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The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

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Draft Legislation:

This is a draft item of legislation and has not yet been made as a UK Statutory Instrument.

Draft Regulations laid before Parliament under paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018, for approval by resolution of each House of Parliament.

Draft Statutory Instruments

2019 No.

Exiting The European Union

Consumer Protection

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Made

***

Coming into force in accordance with regulation 1

The Secretary of State makes the following Regulations in exercise of the powers conferred by section 8(1) of, paragraph 7(2) of Schedule 4 and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018(1).

In accordance with paragraph 1(1) of Schedule 7 to the European Union (Withdrawal) Act 2018 a draft of this instrument has been laid before Parliament and approved by a resolution of each House of Parliament.

The Treasury has consented to the making of these Regulations as required by paragraph 10 of Schedule 4 to the European Union (Withdrawal) Act 2018.

Citation and commencement

1.—(1) These Regulations may be cited as the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, subject to paragraphs (2) to (4), come into force on exit day.

(2) The following regulations come into force on the day that is 4 months after exit day—

(a)regulation 4(4);

(b)regulation 5(3);

(c)regulation 6(3);

(d)regulation 8(2);

(e)regulation 9(2).

(3) Regulation 10, insofar as it inserts regulations 91 to 95, comes into force on 26th May 2020.

(4) Regulation 11, insofar as it inserts regulation 157 to 160, comes into force on 26th May 2022.

Interpretation

2.  In these Regulations—

“the Act” means the European Union (Withdrawal) Act 2018;

“the 2002 Regulations” means the Medical Devices Regulations 2002(2).

PART 1Amendment of the 2002 Regulations

Amendment of Part 1 of the 2002 Regulations

3.—(1) Part 1 of the 2002 Regulations is amended as follows.

(2) After regulation 1(citation and commencement) insert—

Schedules

1A.  Schedules 2 to 28 have effect.;

(3) In regulation 2(3) (interpretation)—

(a)at the start, before “In these Regulations” insert “Subject to Parts VIII and IX,”;

(b)omit the definition of “Association Agreement”;

(c)in the definition of “authorised representative” —

(i)for “established within the Community” substitute “established outside the United Kingdom but within the European Economic Area”,

(ii)for “authorities and bodies in the Community” substitute “authorities and bodies in the European Economic Area”;

(d)after the definition of “clinical data” insert—

“designated standard” has the meaning given in regulation 3A;;

(e)at the end of the definition of “Directive 90/385” insert “as it had effect immediately before exit day”;

(f)at the end of the definition of “Directive 93/42” insert “as it had effect immediately before exit day”;

(g)at the end of the definition of “Directive 98/79” insert “as it had effect immediately before exit day”;

(h)omit the definition of “Directive 2001/83”;

(i)omit the definition of “Directive 2006/42”;

(j)in the definition of “EC CAB” omit “EC”;

(k)omit the definition of “harmonised standard”;

(l)in the definition of “intended for clinical investigation”, in paragraph (b), for “a Member State” substitute “the United Kingdom”;

(m)in the definition of “machinery” for “Article 2(a) of Directive 2006/42” substitute “regulation 4 of the Supply of Machinery (Safety) Regulations 2008(4);”;

(n)in the definition of “medicinal product” for “article 1.2 of Directive 2001/83” substitute “regulation 2(1) of the Human Medicines Regulations 2012(5)”;

(o)for the definition of “Mutual Recognition Agreements” substitute—

“mutual recognition agreement” means an agreement that—

(a)

is between the United Kingdom and a country listed in Schedule 2, and

(b)

covers matters including the conditions under which the United Kingdom and the that country will accept or recognise the results of conformity assessment procedures undertaken by the each other’s designated bodies;;

(p)omit the definition of “national standard”;

(q)in the definition of “notified body”

(i)omit “Part V or”;

(ii)for “the Mutual Recognition Agreements” substitute “a mutual recognition agreement”;

(iii)at the end insert “but, unless the context requires otherwise, does not include a UK notified body”;

(r)in the definition of “placing on the market”—

(i)for “Community” substitute “United Kingdom”;

(ii)at the end insert, “and related expressions must be construed accordingly”;

(s)in the definition of “putting into service” in paragraph (b) for “Community” substitute “United Kingdom”;

(t)in the definition of “stable derivatives device”, in sub-paragraph (a), for “article 1.10 of Directive 2001/83” substitute “regulation 2(2) of the Human Medicines Regulations 2012”;

(u)for the definition of “third party conformity assessment body” substitute—

“third party conformity assessment body” means a body established in a country which is listed in Schedule 2 and designated in accordance with a relevant mutual recognition agreement to carry out conformity assessment procedures for the purposes of these Regulations;

(v)in the definition of “UK notified body” for “regulation 45” substitute “and regulations 4F(8) and 4G(8)”;

(w)after the definition of “UK notified body” insert—

“UK responsible person” means a person established in the United Kingdom who acts on behalf of a manufacturer established outside the United Kingdom in relation to specified tasks with regard to the manufacturer’s obligations under these regulations.

(4) In paragraph (1A), for the words “as amended from time to time” substitute “as they applied immediately before exit day and as modified by Schedule 2A.”.

(5) In regulation 3(6) (scope of these Regulations)—

(a)for the heading substitute, “Scope of Parts II to VII”;

(b)in the opening words before paragraph (a), substitute “Parts II to VII of these Regulations do not apply to”;

(c)in paragraph (a)—

(i)for “Directive 2001/83” in the first place it occurs, substitute “the Human Medicines Regulations 2012”;

(ii)omit “governed by Title X of Directive 2001/83”;

(d)in paragraph (f), for “Council Directive 76/768, as amended” substitute “Regulation (EC) 1223/2009 of the European Parliament and of the Council of 30th November 2009 on cosmetic products;”.

(6) After regulation 3 insert—

Designated standard

3A.(1) In Parts II, III, IV, VIII and IX of these Regulations a “designated standard” means a technical specification which is—

(a)adopted by a recognised standardisation body, for repeated or continuous application, with which compliance is not compulsory; and

(b)designated by the Secretary of State by publishing a reference to the standard and maintaining that publication in a manner the Secretary of State considers appropriate.

(2) For the purposes of paragraph (1), a “technical specification” means a document which prescribes technical requirements to be fulfilled by a device, process, service or system (“the product”) and which lays down—

(a)the characteristics required of a product, including levels of quality, performance, interoperability, environmental protection, health and safety and dimensions;

(b)the requirements applicable to the product as regards the name under which the product is sold, terminology, symbols, testing and test methods, packaging, marking or labelling and conformity assessment procedures; and

(c)the production methods and processes relating to the product, where these have an effect on its characteristics.

(3) For the purposes of this regulation a “recognised standardisation body” means any one of the following organisations—

(a)the European Committee for Standardisation (CEN);

(b)the European Committee for Electrotechnical Standardisation (CENLAC);

(c)the British Standards Institute (BSI).

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the standard to the attention of any person who may have an interest in the standard.

(5) Before publishing the reference to a standard in relation to a technical specification which has been adopted by BSI, the Secretary of State must have regard to whether the technical specification is consistent with technical specifications adopted by the other recognised standardisation bodies.

(6) The Secretary of State may remove from publication the reference to a standard which has been published in accordance with paragraph (1)(b).

(7) Where the Secretary of State removes the reference to a standard from publication, that standard is no longer a designated standard.

(8) In this regulation, a reference to a “device” is a reference to a medical device or its accessory or an in vitro diagnostic medical device or its accessory to which these Regulations apply.

Confidentiality

3B.(1) Subject to paragraph (2), and unless otherwise provided for in these Regulations, all parties involved in the application of these Regulations must respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following—

(a)personal data in accordance with the Data Protection Act 2018(7);

(b)commercially confidential information, trade secrets of a person, including intellectual property rights (unless disclosure is in the public interest);

(c)the effective operation of these Regulations, in particular for the purposes of inspections, investigations or audits.

(2) Paragraph (1) does not affect—

(a)the rights and obligations of the Secretary of State, manufacturers, persons placing products on the market, UK responsible persons, importers, distributors and notified bodies (including UK notified bodies) with regard to the exchange of information and the dissemination of warnings;

(b)obligations to disclose information under the criminal law..

(7) After regulation 4A(8) (transitional provisions for hip, knee and shoulder replacement) insert—

Application of Part VIII to medical devices and their accessories, other than in vitro diagnostic medical devices and their accessories, before 26th May 2020

4B.(1) Part VIII only applies before 26th May 2020 in respect of a device or accessory that is a relevant device for the purposes of Part II or III if the conformity assessment that the person placing it on the market or putting it into service relies on for doing so is the conformity assessment required by Part VIII (rather than by Part II or III).

(2) Accordingly, before 26th May 2020, unless paragraph (1) applies—

(a)Part II continues to apply in respect of a device or accessory that is a relevant device for the purposes of that Part; and

(b)Part III continues to apply in respect of a device or accessory that is a relevant device for the purposes of that Part.

(3) Where Part VIII applies —

(a)Part II ceases to apply, apart from regulations 7A and 19 (to the extent that those regulations otherwise apply, for which see regulations 4D(1) to (5) and 4E(4)); and

(b)Part III ceases to apply, apart from regulations 21A and 30(3) to (5) (to the extent that those regulations otherwise apply, for which see regulations 4D(6) and 4E(4)).

Application of Part IX to in vitro diagnostic medical devices and their accessories before 26th May 2022

4C.(1) Part IX only applies before 26th May 2022 in respect of a device or accessory that is a relevant device for the purposes of Part IV if the conformity assessment that the person placing it on the market or putting it into service relies on for doing so is the conformity assessment required by Part IX (rather than by Part IV).

(2) Accordingly, before 26th March 2022, unless paragraph (1) applies, Part IV continues to apply in respect of a device or accessory that is a relevant device for the purposes of that Part.

(3) Where Part IX applies, Part IV ceases to apply, apart from regulations 33A and 44 (to the extent that those regulations otherwise apply, for which see regulations 4D(8) to (11) and 4E(8)).

Revocations, transitional and saving provisions in respect of the new national registration requirements

4D.(1) Regulation 19 is revoked on the day that is 4 months after exit day (which is the day on which regulation 7A comes into force).

(2) Regulation 7A does not apply until the day that is 8 months after exit day in respect of a device or accessory—

(a)that—

(i)is a relevant device for the purposes of Part II, or

(ii)would be a relevant device for the purposes of Part II, but for the application of regulation 4B(1); and

(b)that is classified (whether or not Part II applies in respect of the device) as belonging to—

(i)Class IIa, as referred to in regulation 7, or

(ii)Class IIb, as referred to in regulation 7, and is also a Group A device (within the meaning given in regulation 52(1)).

(3) Regulation 7A does not apply until the day that is 12 months after exit day in respect of a device or accessory—

(a)that—

(i)is a relevant device for the purposes of Part II, or

(ii)would be a relevant device for the purposes of Part II, but for the application of regulation 4B(1); and

(b)that is classified (whether or not Part II applies in respect of the device) as belonging to Class I, as referred to in regulation 7.

(4) Where regulation 7A does not apply in respect of a device or accessory by virtue of paragraph (2) or (3), regulation 19 continues to have effect after its revocation in respect of that device or accessory, with the modifications in paragraph (5)—

(5) On and after exit day and until its revocation, regulation 19 continues to have effect with the following modifications—

(a)paragraph (3) applies as if for the words “the Community or in a State which is a Party to an Association Agreement” there were substituted “the United Kingdom”; and

(b)as if paragraph (6) were omitted.

(6) Regulation 30(3) is revoked on the day that is 4 months after exit day (which is the day on which regulation 21A comes into force).

(7) On or after exit day and until its revocation, regulation 30(3) continues to have effect with the following modifications—

(a)as if the words “Except as provided in paragraphs (4) and (5)” were omitted;

(b)as if the words “under their own name” were omitted;

(c)as if after Directive 90/385 the following words were inserted “or, if not the manufacturer, the person placing devices on the market under that Article,”.

(8) Regulation 44 is revoked on the day that is 4 months after exit day (which is the day on which regulation 33A comes into force).

(9) Regulation 33A does not apply until the day that is 8 months after exit day in respect of a device or accessory—

(a)that—

(i)is a relevant device for the purposes of Part IV, or

(ii)would be a relevant device for the purposes of Part IV, but for the application of regulation 4C(1); and

(b)that is—

(i)referred to in List B, mentioned in regulation 40(4), or

(ii)a device for self-testing (as defined in relation 32(1)).

(10) Regulation 33A does not apply until the day that is 12 months after exit day in respect of a device or accessory—

(a)that —

(i)is a relevant device for the purposes of Part IV, or

(ii)would be a relevant device for the purposes of Part IV, but for the application of regulation 4C(1); and

(b)that is classified (whether or not Part IX applies in respect of the device) as belonging to Class A, referred to in Schedule 23.

(11) Where regulation 33A does not apply in respect of a device or accessory by virtue of paragraph (9), regulation 44 continues to have effect after its revocation in respect of that device or accessory, with the following modifications—

(a)paragraph (2)(b) applies as if for the words “the Community or a State which is a Party to an Association Agreement” there were substituted “the United Kingdom”; and

(b)as if paragraph (3) were omitted.

(12) On and after exit day and until its revocation, regulation 44 continues to have effect with the following modifications—

(a)paragraph (2)(b) applies as if for the words “the Community or a State which is a Party to an Association Agreement” there were substituted “the United Kingdom”; and

(b)as if paragraph (3) were omitted.

Transitional provisions in respect of the European Commission’s UDI database

4E.(1) Subject to paragraph (3), regulations 91 to 95 do not apply until the date which is 6 months after the date on which the UDI database managed by the European Commission becomes fully functional (a date that the European Commission is required to publish in the Official Journal of the European Union), unless that date (“the operational date”) is before 26th May 2020.

(2) Accordingly, until the operational date—

(a)the following provisions do not apply—

(i)regulation 76(9)and (14)(c)(viii),

(ii)regulation 101(2),

(iii)paragraph 23(3)(h) of Schedule 3,

(iv)paragraph 1(c) of Schedule 6, and

(v)Schedule 8; and

(b)the following provisions only apply with the following modifications—

(i)regulation 100(2), as if the words from “Except for” to “94 to 96,” were omitted; and

(ii)regulation 118(9)(a), as if the words “when the device is registered in accordance with regulation 94 and” were omitted.

(3) Regulation 91(4) only applies in respect of a device to which Part VIII applies, or in respect of an accessory to such a device—

(a)on and after 26th May 2021 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as—

(i)an implantable device, or an accessory to such a device, or

(ii)a Class III device, or an accessory to such a device;

(b)on and after 26th May 2023 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as—

(i)a Class IIa device, or an accessory to such a device, or

(ii)a Class IIb device, or an accessory to such a device;

(c)on and after 26th May 2025 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as a Class 1 device, or an accessory to such a device;

(d)on and after the date which is 2 years after the operational date, in the case of a device considered to be a reusable device, or an accessory to such a device, in circumstances where it is required to bear the UDI carrier on the device or accessory itself.

(4) If the operational date is before 26th May 2020, regulations 7A and 21A cease to apply on the operational date in respect of a device or accessory to which Part VIII applies because regulation 4B(1) applies.

(5) Subject to paragraph (7), regulations 157 to 160 do not apply until the date which is 6 months after the operational date, unless the operational date is before 26th May 2022.

(6) Accordingly, before the operational date—

(a)the following provisions do not apply—

(i)regulation 145(8)and (13)(c)(viii), and

(iii)Schedule 22; and

(b)the following provisions only have effect with the following modifications—

(i)regulation 161(4)(a), as if the words “including the basic UDI-DI” were omitted; and

(ii)regulation 165(2), as if the words from “Except for” to “158 or 160,” were omitted.

(7) Regulation 157(4) only applies in respect of a device to which Part VIII applies, or an accessory to such a device—

(a)on and after 26th May 2023 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 23 as a Class D device, or an accessory to such a device;

(b)on and after 26th May 2025 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 23 as—

(i)a Class C device, or an accessory to such a device, or

(ii)a Class B device, or an accessory to such a device; or

(c)on and after 26th May 2027 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 23 as a Class A device, or an accessory to such a device.

(8) If the operational date is before 26th May 2022, regulation 33A ceases to apply on the operational date in respect of a device or accessory to which Part IX applies because regulation 4C(1) applies.

Application of Parts II and III on and after 26th May 2020, the related transitional provisions and the revocation of Parts II and III on 26th May 2025

4F.(1) Parts II and Part III are revoked on 26th May 2025.

(2) Pending their revocation, Parts II and III cease to apply on 26th May 2020, except as provided for in this regulation.

(3) Subject to paragraph (4), regulations 7A and 21A continue to apply on and after 26th May 2020 unless by virtue of regulation 4E(4) they ceased to apply before that date in respect of devices or accessories to which Part VIII applies (in which case regulations 7A and 21A cease to apply for all purposes on 26th May 2020).

(4) Unless, by virtue of paragraph (3), they ceased to apply for all purposes on 26th May 2020, regulations 7A and 21A cease to apply on the date which is 6 months after the date on which the UDI database managed by the European Commission becomes fully functional (a date that the European Commission is required to publish in the Official Journal of the European Union).

(5) Certificates issued in accordance with Directive 90/385 or Directive 93/42 before 26th May 2020 remain valid on and after 26th May 2020—

(a)if issued before 26th May 2017 otherwise than in accordance with Annex 4 of Directive 90/385 or Annex IV of Directive 93/42, until the end of the period indicated on the certificate or, if sooner, 26th May 2025;

(b)if issued before 26th May 2017 in accordance with Annex 4 of Directive 90/385 or Annex IV of Directive 93/42, until the end of the period indicated on the certificate or, if sooner, 26th May 2022;

(c)if issued on or after 26th May 2017 but before 26th May 2020, until whichever of the following is the soonest—

(i)the end of the period indicated on the certificate,

(ii)the end of the period of 5 years from the date on which the certificate was issued, or

(iii)26th May 2024.

(6) Subject to paragraph (7), Part II or III continues to apply on and after 26th May 2020 in respect of a device or an accessory that is a relevant device for the purposes of Part II or III, in circumstances where—

(a)the conformity assessment that the person placing it on the market or it into service relies on for doing so is the conformity assessment required by Part II or III;

(b)as a consequence, there is in respect of that relevant device a certificate of conformity, the validity of which is preserved by paragraph (5);

(c)since the issuing of that certificate, there have been no significant changes to the design or intended purpose of the relevant device; and

(d)the notified body responsible for that certificate continues to fulfil its obligations in respect of the continued supervision of the relevant device.

(7) The requirements of Part VIII in respect of post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices apply in place of the corresponding requirements of Parts II and III (although regulations 7A and 21A may continue to apply, subject to paragraphs (3) and (4)).

(8) For the purposes of paragraph (6)(d)—

(a)a body does not cease, as a consequence of the withdrawal of the United Kingdom from the European Union, to be the notified body responsible for a certificate if—

(i)it was a notified body designated as a UK notified body in accordance with regulation 45 (designation of notified bodies) as it applied immediately before exit day, and

(ii)before exit day, that designation had not been withdrawn under regulation 45(5);

(b)a notified body fulfils its obligations if it carries out the activities required by the following provisions as they apply to the devices covered by the relevant certificate—

(i)for relevant devices to which Part II applies, the Annexes to Directive 93/42 and in particular sections 5 and 7.5 of Annex II, section 4 of Annex V and section 4 of Annex VI, and

(ii)for relevant devices to which Part III applies, the Annexes to Directive 90/385 and in particular section 5 of Annex 2 and section 4 of Annex 5 to Directive 90/385.

Application of Part IV on and after 26th May 2022, the related transitional provisions and the revocation of Part IV on 26th May 2025

4G.(1) Part IV is revoked on 26th May 2025.

(2) Pending its revocation, Part IV ceases to apply on 26th May 2022, except as provided for in this regulation.

(3) Subject to paragraph (4), regulation 33A continues to apply on and after 26th May 2022 unless by virtue of regulation 4E(8) it ceased to apply before that date in respect of devices or accessories to which Part IX applies (in which case regulation 33A ceases to apply for all purposes on 26th May 2022).

(4) Unless, by virtue of paragraph (3), it ceased to apply for all purposes on 26th May 2022, regulation 33A ceases to apply on the date which is 6 months after the date on which the UDI database managed by the European Commission becomes fully functional (a date that the European Commission is required to publish in the Official Journal of the European Union).

(5) Certificates issued in accordance with Directive 98/79 before 26th May 2022 remain valid on and after 26th May 2022—

(a)if issued before 26th May 2017 otherwise than in accordance with Annex VI of Directive 98/79, until the end of the period indicated on the certificate or, if sooner, 26th May 2025;

(b)if issued before 26th May 2017 in accordance with Annex VI of Directive 98//79, until the end of the period indicated on the certificate or, if sooner, 26th May 2024;

(c)if issued on or after 26th May 2017 but before 26th May 2020, until the end of the period indicated on the certificate or, if sooner, 26th May 2024.

(6) Subject to paragraph (7), Part IV continues to apply on and after 26th May 2022 in respect of a device or an accessory that is a relevant device for the purposes of that Part, in circumstances where—

(a)the conformity assessment that the person placing it on the market or it into service relies on for doing so is the conformity assessment required by Part IV;

(b)as a consequence, there is in respect of that relevant device a certificate of conformity, the validity of which is preserved by paragraph (5);

(c)since the issuing of that certificate, there have been no significant changes to the design or intended purpose of the relevant device; and

(d)the notified body responsible for that certificate continues to fulfil its obligations in respect of the continued supervision of the relevant device.

(7) The requirements of Part IX in respect of post-market surveillance, market surveillance, vigilance and registration of economic operators and of devices apply in place of the corresponding requirements of Part IV (although regulation 33A may continue to apply, subject to paragraphs (3) and (4)).

(8) For the purposes of paragraph (6)(d)—

(a)a body does not cease, as a consequence of the withdrawal of the United Kingdom from the European Union, to be the notified body responsible for a certificate if—

(i)it was a notified body designated as a UK notified body in accordance with regulation 45 (designation of notified bodies) as it applied immediately before exit day, and

(ii)before exit day, that designation had not been withdrawn under regulation 45(5); and

(b)a notified body fulfils its obligations if it carries out the activities required by the Annexes to Directive 98/79 and in particular by section 5 of Annex IV and section 4 of Annex VII to Directive 98/79, as they apply to the devices covered by the relevant certificate.

Revocation of Commission Decision 2002/364 on 26th May 2025 and its effect before that date

4H.(1) Commission Decision 2002/364/EC of 7 May 2002 on the common specifications for in vitro diagnostic medical devices(9) (“the Decision”) (insofar as it is retained EU law) is revoked on 26th May 2025.

(2) Pending its revocation, the Decision has effect as it had effect immediately before exit day.

Revocation of Commission Decision 2010/227

4I.  Commission Decision 2010/227/EU of 19 April 2010 on the European Databank on Medical Devices (Eudamed)(10) is revoked.

Revocation of Regulation (EU) No 207/2012 on 26th May 2025 and its effect before that date

4J.(1) Except as provided for in this regulation, pending its revocation by the European Commission(11), Regulation (EU) No 207/2012 has effect as it had effect immediately before exit day.

(2) Before 26th May 2020, Regulation (EU) No. 207/2012 only applies as regards—

(a)a device or accessory which is a relevant device for the purposes of Part II or III in respect of which Part II or III continue to apply by virtue of regulation 4B(2) or a device to which Part VIII applies by virtue of regulation 4B(1);

and

(b)as if—

(i)the reference to a notified body in Article 8 included reference to a UK notified body, where that UK notified body is responsible for the certificate of conformity that remains valid by virtue of regulation 4F(5), but

(ii)Article 8 were otherwise omitted.

(3) On and after 26th May 2020 but before 26th May 2025, Regulation (EU) No 207/2012 only applies as regards—

(a)a device or accessory that is a relevant device for the purposes of Part II or III in respect of which Part II or III continues to apply by virtue of regulation 4F(6) (subject to regulation 4F(7)) or a device to which Part VIII applies; and

(b)as if—

(i)the reference to a notified body in Article 8 included reference to a UK notified body, where that UK notified body is responsible for the certificate of conformity that remains valid by virtue of regulation 4F(5), but

(ii)Article 8 were otherwise omitted.

Revocation of Regulation (EU) No 722/2012 on 26th May 2025 and its effect before that date

4K.(1) Except as provided for in this regulation, pending its revocation by the European Commission(12), Regulation (EU) No 722/2012 has effect as it had effect immediately before exit day.

(2) Before 26th May 2020, Regulation (EU) No 722/2012 applies as regards—

(a)a device or accessory that is a relevant device for the purposes of Part II or III in respect of which Part II or III continues to apply by virtue of regulation 4B(2);

(b)a device to which Part VIII applies by virtue of regulation 4B(1);

(3) On and after 26th May 2020 but before 26th May 2025, Regulation (EU) No 722/2012 applies as regards a device or accessory that is a relevant device for the purposes of Part II or III in respect of which Part II or III continues to apply by virtue of regulation 4F(6) (subject to regulation 4F(7)) or to devices to which Part VIII applies.

(4) Before 26th May 2025, Regulation (EU) No 722/2012 only applies as regards a UK notified body—

(a)where the UK notified body is responsible for a certificate of conformity issued for the relevant device in accordance with Directive 90/385 or Directive 93/42 that remains valid by virtue of regulation 4F(5); and

(b)to the extent this is necessary for the fulfilment by the UK notified body of its obligations as regards the relevant device for the purposes of Part II or III.

Revocation of Regulation (EU) No 920/2013 on 26th May 2025 and its effect before that date

4L.(1) Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices(13) (“Regulation (EU) No 920/2013”) (insofar as it is retained EU law) is revoked on 26th May 2025.

(2) Except as provided for in this regulation, pending its revocation, Regulation (EU) No 920/2013 has effect as it had effect immediately before exit day.

(3) Before 26th May 2025, Regulation (EU) No 920/2013 only applies as regards a UK notified body—

(a)where the UK notified body is responsible for a certificate of conformity issued for the device or accessory in accordance with Directive 90/385 or Directive 93/42 that remains valid by virtue of regulation 4F(5); and

(b)to the extent this is necessary for the fulfilment by the UK notified body of its obligations as regards the device or accessory for the purposes of Part II or III.

(4) Before 26th May 2025, Regulation (EU) No 920/2013 only applies as regards the functions of the Secretary of State as a designating authority for the purpose of that Regulation, to the extent necessary for the fulfilment by the Secretary of State of the Secretary of State’s obligations as regards the supervision of UK notified bodies.

(5) Paragraph (4) only applies in respect of the functions of the Secretary of State—

(a)which allow for or require the exchange of information with designating authorities in the European Union or with the European Commission; and

(b)insofar as there are in place reciprocal arrangements with the EU, an EU entity, a member State or a public authority in a member State that allow for or require that exchange.

Revocation of Regulation (EU) No 2017/2185 and saving provision

4M.(1) Insofar as it is retained EU law, Commission Implementing Regulation (EU) 2017/2185 of 23 November 2017 on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council(14) (“Regulation (EU) No 2017/2185”) is revoked.

(2) Notwithstanding paragraph (1), where conformity assessment of medical devices under Part VIII or IX requires involvement of a notified body in the European Union and the use of one of the codes listed in Regulation (EU) No. 2017/2185, that that Regulation is saved to the extent necessary to give effect to that requirement.

The classification criteria in Directives 2003/12 and 2005/50

4N.  Where regulation 7 applies either in accordance with regulation 4B(2)(a), or for the purposes of regulation 4D(2)(b) or (3)(b), or by virtue of regulation 4F(6), Directives 2003/12 and 2005/50 apply with the following modifications—

(a)in the case of Directive 2013/12, as if Articles 2 to 4 were omitted; and

(b)in the case of Directive 2005/50, as if Articles 3 to 6 were omitted.

Revocation of Regulation (EU) 2017/745

4O.(1) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (“the Medical Devices Regulation”) (insofar as it is retained EU law) is revoked.

(2) Part VIII applies in respect of a device or accessory placed on the market or put into service before exit day in accordance with the conformity assessment required by the Medical Devices Regulation as it applies to a device or accessory placed on the market or put into service in accordance with Part VIII.

Revocation of Regulation (EU) 2017/746

4P.(1) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“the in vitro diagnostic medical devices Regulation”) (insofar as it is retained EU law) is revoked.

(2) Part IX applies in respect of a device or accessory placed on the market or put into service before exit day in accordance with the conformity assessment required by the Medical Devices Regulation as it applies to a device or accessory placed on the market or put into service in accordance with Part IX.

Modifications to deal with serious shortages

4Q.(1) The Secretary of State may by regulations modify the application of any of the provisions of these Regulations in circumstances where, in the Secretary of State’s opinion, the United Kingdom or any part of the United Kingdom is experiencing or may experience a serious shortage, arising from the withdrawal of the United Kingdom from the European Union, of a device or accessory of a specified description that—

(a)is a relevant device for the purposes of Part II, III or IV; or

(b)would be a relevant device for the purposes of Part II, III or IV but for the application of regulation 4B(1) or 4C(1).

(2) Regulations may only be made under paragraph (1) for the purposes of preventing, remedying or mitigating the serious shortage that in the opinion of the Secretary of State is being or may be experienced.

(3) The reference in paragraph (1) to a serious shortage arising from the withdrawal of the United Kingdom from the European Union includes reference to a serious shortage where the withdrawal of the United Kingdom from the European Union is one but not the only significant factor contributing to the shortage.

(4) No regulations under paragraph (1) may be made, or have effect after the end of the period of 2 years beginning with exit day.

(5) The power to make regulations under paragraph (1) is exercisable by statutory instrument.

(6) Regulations made under paragraph (1) are subject to annulment by resolution of either House of Parliament.

References in other legislation to expressions used in these Regulations

4R.(1) In the following provisions, where reference is made, in whatever form, to the expression “medical device” having the meaning given in regulation 2, to the extent necessary for the practical application of that definition, the reference to regulation 2 is to be construed as a reference also or instead to regulation 69—

(a)the definitions of “electronic cigarette” and “electronic cigarette refill container” in section 368R of the Communications Act 2003(15) (interpretation of Part 4A);

(b)regulation 4(3)(b)(ii) of the National Health Service Commissioning Board (Additional Functions) Regulations 2017(16) (power to conclude and manage framework agreements);

(c)the definition of “medical device” in regulation 2(1) of the Tobacco and Related Products Regulations 2016(17) (interpretation);

(d)the definition of “medical device” in regulation 1(4) of the Nicotine Inhaling Products (Age of Sale and Proxy Purchasing) Regulations 2015(18) (citation, commencement and interpretation);

(e)the definition of “equipment” in regulation 2(1) of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014(19) (interpretation);

(f)the definition of “medical device” in regulation 2(1) of the Restriction on the Use of Certain Hazardous Substances in Electrical and Electrical Equipment Regulations 2012(20) (interpretation); and

(g)the definition of “medical device” in article 3(1) of the Pharmacy Order 2010(21) (interpretation).

(2) In regulation 2(1) of the Restriction on the Use of Certain Hazardous Substances in Electrical and Electrical Equipment Regulations 2012, where reference is made to the expression “in vitro diagnostic medical device” having the meaning given in regulation 2, to the extent necessary for the practical application of that definition, “in vitro diagnostic medical device” is be construed as also or instead having the meaning given to “in vitro diagnostic medical device” in regulation 137.

(3) In sub-paragraph (c) of the definition of “manufacturer” in regulation 1(3) of the Blood Safety and Quality Regulations 2005(22) (citation, commencement and interpretation), the reference made to the definition of “manufacturer” in relation 2(1) is to be construed, to the extent necessary for the practical application of that definition, as if it were defined also or instead by reference to regulation 69.

(4) In the following provisions, where reference is made to regulation 15, to the extent necessary for the practical application of the provision, that reference is to be construed as a reference also or instead to regulation 76(7)—

(a)paragraph 32(3)(e) of Schedule 3 to the National Health Service (General Dental Services Contracts) (Wales) Regulations 2006(23) (other contractual terms – patient records);

(b)paragraph 33(3)(e) of Schedule 3 to the National Health Service (Personal Dental Services Agreements) (Wales) Regulations 2006(24) (other contractual terms – patient records);

(c)paragraph 33(3)(e) of Schedule 3 to the National Health Service (Personal Dental Services Agreements) Regulations 2005(25) (other contractual terms – patient records); and

(d)paragraph 32(3)(e) of Schedule 3 to the National Health Service (General Dental Services Contracts) Regulations 2005(26) (other contractual terms – patient records).

Use in other legislation of a definition of “medical device” based on the definition in Directive 93/42

4S.  In the following provisions, the definition of “medical device” is to be construed, to the extent necessary for the practical application of that definition, as if it were defined also or instead by reference to regulation 69—

(a)regulation 1(3) of the National Health Service (Cross-Border Healthcare) Regulations 3013(27) (citation, commencement, extent and interpretation);

(b)regulation 2 of the National Health Service (Cross-Border Health Care) (Scotland) Regulations 2013(28) (interpretation); and

(c)regulation 2(1) of the Health Services (Cross-Border Health Care) Regulations (Northern Ireland) 2013(29) (interpretation).

References in other legislation to Directives 90/385, 93/42 and 98/79

4T.(1) In section 1(12)(a) of the Human Tissue Act 2004(30) (authorisation of activities for scheduled purposes), the references to Directive 98/79 are to be construed, to the extent necessary for the practical application of that section, as references also or instead to Parts IV and IX.

(2) In regulation 10(5) of the Medicines (Products for Human Use) (Fees) Regulations 2016(31) (fee for advice for other purposes)—

(a)the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to having the meaning given in regulation 2 or 69; and

(b)the reference to paragraph 5 of Annex III to Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to Schedule 11.

(3) In Schedule 1 to the Pressure Equipment (Safety) Regulations 2016(32) (excluded pressure equipment and assemblies), the reference in paragraph 1(f)(iv) to not being covered by Directive 93/42 is to be construed, to the extent necessary for the practical application of that provision, as a reference also or instead to not being covered by Part II or VIII.

(4) In regulation 2 of the Waste Electrical and Electronic Equipment Regulations 2013(33) (interpretation)—

(a)the reference to the expression “active implantable medical device” having the meaning given in Article 1(2)(c) of Directive 90/385 is to be construed, to the extent necessary for the practical application of that definition, as a reference also or instead to it having the meaning given in regulation 2 or in accordance with Schedule 9;

(b)the reference to the expression “medical device” having the meaning given in Article 1(2)(a) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as a reference to it also or instead having the meaning given to it in regulation 2 or 69;

(c)the reference to the expression “accessory” having the meaning given in Article 1(2)(b) of Directive 93/42 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 5 or to “accessory for a medical device” in regulation 69;

(d)the reference to the expression “in vitro diagnostic medical device” having the meaning given in Article 1(2)(b) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as—

(i)having the meaning given to it in regulation 2, or

(ii)also or instead having the meaning given to “in vitro medical device” in regulation 137.

(e)the reference to the expression “accessory” having the meaning given in Article 1(2)(c) of Directive 98/79 is to be construed, to the extent necessary for the practical application of that definition, as also or instead having the meaning given to “accessory” in regulation 32 or to “accessory for an in vitro diagnostic medical device” in regulation 137.

(5) These Regulations are an enactment implementing a relevant Community Directive for the purposes of regulation 4 of the Personal Protective Equipment at Work Regulations (Northern Ireland) 1993(34) (provision of personal protective equipment).

(6) These Regulations are also an enactment implementing a relevant Community Directive for the purposes of regulation 4(5)(a) of the Personal Protective Equipment at Work Regulations 1992(35) (provision of personal protective equipment)..

Amendment of Part II of the 2002 Regulations

4.—(1) Part II of the 2002 Regulations is amended as follows.

(2) In regulation 6 (Scope of Part II) after paragraph (c) insert—

(d)except for the requirement to register under regulation 7A or 19, medical devices or accessories to such devices placed on the market in accordance with Part VIII..

(3) In regulation 7 (Classification of general medical devices), omit paragraph (2).

(4) After regulation 7 insert—

Registration of persons placing general medical devices on the market

7A.(1) No person may place a relevant device on the market in accordance with this Part (or Part VIII insofar as it applies to relevant devices) unless that person—

(a)is established in the United Kingdom; and

(b)has complied with paragraph (2).

(2) A person complies with this paragraph if, before placing the relevant device on the market, the person—

(a)informs the Secretary of State of the address of their registered place of business in the United Kingdom or, if the person does not have a registered place of business, an address in the United Kingdom at which service of any document relating in any way to the person’s placing of the relevant device on the market will be effective;

(b)if they are not the manufacturer of the relevant device, provides the Secretary of State with written evidence that they have the manufacturer’s authority to place the relevant device on the market;

(c)supplies the Secretary of State with a description of the relevant device; and

(d)pays to the Secretary of State the relevant fee in accordance with regulation 53.

(3) Where a person provides the Secretary of State with the written evidence required by paragraph (2)(b), that person is to be regarded as the UK responsible person and that person must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d)forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples or has been given access to the device;

(e)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(f)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(g)terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

(4) In this regulation the references to “technical documentation” and “declaration of conformity” are to be construed in accordance with the following—

(a)where this regulation applies and Part II applies —

(i)the reference to technical documentation is to be construed in accordance with Annex II, III or VII;

(ii)the reference to the declaration of conformity is to be construed in accordance with Annexes II, IV, V, VI and VII as applied by regulation 13;

(b)where this regulation applies and Part VIII applies—

(i)the reference to technical documentation is to be construed in accordance with Schedules 4 and 5;

(ii)the reference to the declaration of conformity is to be construed in accordance with regulation 84..

(5) In regulation 8 (essential requirements for general medical devices), in paragraph (3), for “Annex I to Directive 2006/42” insert “Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008”.

(6) In regulation 9 (determining compliance of general medical devices with relevant essential requirements)—

(a)in paragraph (3)(b)—

(i)in sub-paragraph (i) omit “or another Community language, and”,

(ii)omit sub-paragraph (ii);

(b)in paragraph (9)—

(i)for the words from “Council Directive 89/686/EEC to “protective equipment” substitute “Regulation (EU) 2016/425 of the European Parliament and of the Council of 9th March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC”;

(ii)for “Directive 89/686” substitute “Regulation (EU) 2016/425”.

(7) In regulation 12 (Exemptions from regulations 8 and 10) after paragraph (5) insert—

(6) Regulations 8 and 10 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards, or which is marked other than with a CE marking, which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 8 and 10, may be placed on the market.

(7) In paragraph (6), the Secretary of State, in determining whether another standard requirement, or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 8 and 10, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations..

(8) In regulation 17(36) (Manufacturers etc. and conformity assessment procedures for general medical devices), omit paragraph (3).

(9) Omit regulation 18(37) (UK notified bodies and the conformity assessment procedures for general medical devices).

Amendment of Part III of the 2002 Regulations

5.—(1) Part III of the 2002 Regulations is amended as follows.

(2) In regulation 21(38) (Scope of Part III)—

(a)in paragraph (2), for “Annex I to that Directive” substitute “Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008”;

(b)after paragraph (3) insert—

(4) Except for the requirement to register in accordance with regulation 21A or 30(3) to (5), this Part does not apply to active implantable medical devices and accessories to such devices placed on the market in accordance with Part VIII..

(3) After regulation 21 insert—

Registration of persons placing active implantable medical devices on the market

21A.(1) No person may place a relevant device on the market in accordance with this Part or Part VIII insofar as it applies to relevant devices unless that person—

(a)is established in the United Kingdom; and

(b)has complied with paragraph (2).

(2) A person complies with this paragraph if, before placing the relevant device on the market, the person—

(a)informs the Secretary of State of the address of their registered place of business in the United Kingdom or, if the person does not have a registered place of business, an address in the United Kingdom at which service of any document relating in any way to the person’s placing of the relevant device on the market will be effective;

(b)if they are not the manufacturer of the relevant device, provides the Secretary of State with written evidence that they have the manufacturer’s authority to place the relevant device on the market;

(c)supplies the Secretary of State with a description of each device concerned; and

(d)pays to the Secretary of State the relevant fee in accordance with regulation 53.

(3) Where a person provides the Secretary of State with the written evidence required by paragraph (2)(b), that person is to be regarded as the UK responsible person and that person must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available to the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d)forward to the manufacturer any request by the Secretary of State for samples, or access to a device and verify that the Secretary of State receives the samples or is given access to the device;

(e)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(f)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(g)terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

(4) In this regulation the references to “technical documentation” and “declaration of conformity” are to be construed in accordance with the following—

(a)where this regulation applies and Part III applies—

(i)the reference to technical documentation is to be construed in accordance with Annex 2, 3 or 5;

(ii)the reference to the declaration of conformity is to be construed in accordance with Annexes 2,3 and 5 as applied by regulation 27;

(b)where this regulation applies and Part VIII applies—

(i)the reference to technical documentation is to be construed in accordance with Schedules 4 and 5;

(ii)the reference to the declaration of conformity is to be construed in accordance with regulation 84..

(4) In regulation 23 (Determining compliance of active implantable medical devices with relevant essential requirements), in paragraph 3(b)—

(a)in sub-paragraph (i), omit “or another Community language, and”;

(b)omit sub-paragraph (ii).

(5) In regulation 26 (Exemptions from regulations 22 and 24) after paragraph (3) insert—

(4) Regulations 22 and 24 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a CE marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 22 and 24, may be placed on the market.

(5) In paragraph (4), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 22 and 24, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations..

(6) In regulation 30(39) omit paragraphs (4) and (5).

(7) Omit regulation 31(40) (UK notified bodies and the conformity assessment procedures for active implantable medical devices).

Amendment of Part IV of the 2002 Regulations

6.—(1) Part IV of the 2002 Regulations is amended as follows.

(2) In regulation 33 (Scope of Part IV)—

(a)after paragraph 1(b) insert—

(c)in vitro diagnostic medical devices and accessories to such devices placed on the market in accordance with Part IX except where the requirement to register in accordance with regulation 33A applies in respect of these devices.;

(b)after paragraph 2(b) insert—

(c)devices that are placed on the market in accordance with Part IX except where the requirement to register in accordance with regulation 33A applies in respect of these devices..

(3) After regulation 33 insert—

Registration etc. of persons placing in vitro diagnostic medical devices on the market

33A.(1) No person may place a relevant device on the market in accordance with this Part, or Part IX insofar as it applies to relevant devices, unless that person—

(a)is established in the United Kingdom; and

(b)has complied with paragraph (2).

(2) A person complies with this paragraph if, before placing a relevant device on the market, the person—

(a)informs the Secretary of State of the address of their registered place of business in the United Kingdom or, if the person does not have a registered address, an address in the United Kingdom at which service of any document relating in any way to the person’s placing of a relevant device on the market will be effective;

(b)if they are not the manufacturer of the relevant device, provides the Secretary of State with sufficient written evidence that they have the manufacturer’s authority to place the relevant device on the market;

(c)supplies the Secretary of State with relevant information in relation to each device concerned; and

(d)pays to the Secretary of State the relevant fee in accordance with regulation 53.

(3) Where a person provides the Secretary of State with the evidence required by paragraph (2)(b), that person is to be regarded as the UK responsible person and that person must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d)forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples or has been given access to the device;

(e)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(f)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(g)terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

(4) In this regulation “relevant information” means—

(a)in relation to a new relevant device, a statement indicating that the device is a new relevant device;

(b)if the device consists wholly or partly of reagents, reagent products or calibration and control materials, appropriate information in terms of common technological characteristics and analytes;

(c)if the device does not wholly or partly consist of reagents, reagent products or calibration and control materials, the appropriate indications;

(d)in relation to devices in a list in Annex II and devices for self-testing—

(i)all data allowing for identification of such devices, the analytical and, where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex 1;

(ii)if requested by the Secretary of State, the labelling and instructions for use for when the device is placed on the market or put into service;

(e)in relation to devices for performance evaluation which relate either to devices referred to in a list in Annex II or to devices for self-testing, all data allowing for identification of such devices, the analytical and where appropriate, diagnostic parameters as referred to in Section 3 of Part A of Annex I.

(5) Within two years of the placing of a new relevant device on the market, the Secretary of State may, where the Secretary of State considers it justified, request a report relating to the experience gained with the device subsequent to it being placed on the market.

(6) In this regulation a device is a “new relevant device” if—

(a)there has been no such device continuously available on the United Kingdom or other market during the previous three years for the relevant analyte or other parameter; or

(b)use of the device has involved analytical technology not continuously used in connection with a given analyte or other parameter on the United Kingdom or other market during the previous three years.

(7) In paragraph (3) the references to “technical documentation” and “declaration of conformity” are to be construed in accordance with the following—

(a)where this regulation applies and Part IV applies—

(i)the reference to technical documentation is to be construed in accordance with Annexes III to VIII;

(ii)the reference to the declaration of conformity is to be construed in accordance with Annexes III, IV, V and VII as applied by regulation 40;

(b)where this regulation applies and Part IX applies—

(i)the reference to technical documentation is to be construed in accordance with Schedules 18 and 19;

(ii)the reference to the declaration of conformity is to be construed in accordance with regulation 153..

(4) In regulation 35 (Determining compliance of in vitro diagnostic medical devices with relevant essential requirements), in paragraph (2), omit the words from “if the device may reach a final user” to the end.

(5) In regulation 39 (Exemptions from regulations 34, 36 and 38), after paragraph (2) insert—

(3) Regulations 34 and 36 do not apply where the Secretary of State directs that a relevant device, or a class of relevant devices, which meets other requirements or standards or which is marked other than with a CE marking which the Secretary of State determines is equivalent to the requirements and standards imposed by regulations 34 and 36, may be placed on the market.

(4) In paragraph (3), the Secretary of State, in determining whether a standard or requirement or marking (“the other standard”) is equivalent to a standard or requirement imposed by regulations 34 and 36, must be satisfied that the other standard imposes a degree of safety and quality equivalent to that imposed by those regulations..

(6) In regulation 41 (Manufacturers etc. and conformity assessment procedures for in vitro diagnostic medical devices) in paragraph (5)—

(a)omit from the beginning to “established”;

(b)omit “in the United Kingdom”.

(7) Omit regulation 42 (UK notified bodies and the conformity assessment procedures for in vitro diagnostic medical devices).

Amendment of Part V of the 2002 Regulations

7.—(1) Part V of the 2002 Regulations is amended as follows.

(2) In regulation 45(41) (Designation etc. of UK notified bodies)—

(a)in the heading, omit “Designation etc. of”;

(b)for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”;

(c)omit paragraphs (1) to (3);

(d)in paragraph (5)—

(i)in the introductory wording, omit “under paragraph (1)”;

(ii)in sub-paragraph (c) omit “under paragraph (1)”.

(3) In regulation 47(42)—

(a)in paragraph (1)—

(i)for “an application has been made” substitute “, before exit day, an application was made”;

(ii)for “shall perform those functions”, substitute “shall perform the functions set out in regulation 67A(5)”;

(b)in paragraph (3)—

(i)for the first mention of “notified body” substitute “UK notified body”;

(ii)omit “, if the notified body is within the United Kingdom,”;

(iii)omit “or some other Community language acceptable to the notified body concerned”;

(c)in paragraph (5), for “notified body” in both places it occurs substitute “UK notified body”;

(d)in paragraphs (6) and (8), for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”.

(4) In regulation 48 (Designation etc. of EC conformity assessment bodies)—

(a)in the heading and in each other place it occurs omit “EC”;

(b)for “the Mutual Recognition Agreements” in each place it occurs, substitute “a mutual recognition agreement”;

(c)in paragraph (1) omit “European Community”.

(5) In regulation 49 (Fees charged by UK notified bodies and EC conformity assessment bodies)—

(a)in the heading and in each other place it occurs omit “EC”;

(b)for “the Mutual Recognition Agreements” in both places, substitute “a mutual recognition agreement”;

(c)in paragraph (1), for “under the Medical Devices Directives”, substitute “under these Regulations”.

Amendment of Part VI of the 2002 Regulations

8.—(1) Part VI of the 2002 Regulations is amended as follows.

(2) In regulation 53(43) (Fees in connection with the registration of devices and changes in registration details)—

(a)for “regulation 19 or 44” substitute “regulations 7A, 19, 21A, 33A, 44, 93, 95, 158 or 160”;

(b)after “registration of that person” insert “or, in the case of registration of a device, the device”.

(3) In regulation 54(44) (Fees payable in connection with the designation of UK notified bodies)—

(a)in the heading omit “with the designation etc. of”;

(b)for “the Mutual Recognition Agreements” in both places, substitute “a mutual recognition agreement”;

(c)omit paragraph (1);

(d)omit paragraph (3C);

(e)in paragraph (4), omit sub-paragraph (a).

(4) In regulation 55(45) (Fees payable in connection with the designation etc. of EC conformity assessment bodies —

(a)in the heading and in every other place it occurs omit “EC”;

(b)in paragraph (3), for “the Mutual Recognition Agreements”, substitute “a mutual recognition agreement”.

(5) In regulation 58 (Waivers, reductions and refunds) in paragraph (2)—

(a)at the end of sub-paragraph (a) omit “or”;

(b)omit sub-paragraph (b);

(c)after sub-paragraph (b) in the full out words omit from “(other than” to “the Secretary of State”.

Amendment of Part VII of the 2002 Regulations

9.—(1) Part VII of the 2002 Regulations is amended as follows.

(2) In regulation 59(46)(interpretation of Part VII)—

(a)omit the definition of “registrable device”;

(b)in the definition of “relevant device” after “IV” insert “or a device for the purposes of Part VIII or IX.”.

(3) In regulation 60(47) (designation etc. of authorised representatives)—

(a)for the heading substitute “Status of UK responsible person”;

(b)omit paragraphs (1) and (2);

(c)for paragraph (3), substitute—

A UK responsible person—

(a)may be proceeded against as a person placing the device on the market for the purposes of these regulations;

(b)in relation to the supply of the device to a person within the United Kingdom after it has been placed on the market, may be proceeded against as a person supplying the device after it has been placed on the market..

(d)in paragraph (4), for “an authorised representative” substitute “a UK responsible person”.

(4) In regulation 61(48) (enforcement etc.)—

(a)in paragraph (8) in sub-paragraph (a)—

(i)in paragraph (i), after “essential requirement” insert “, a general safety and performance requirement”;

(ii)in paragraph (ii), omit “set out in the Medical Devices Directives”;

(b)in sub-paragraph (b), after “performance evaluation” insert “or study”.

(5) In regulation 62 (compliance notices) in paragraph (1)—

(i)after “performance evaluation” insert “or study”;

(ii)for “the manufacturer or his authorised representative” substitute “any person”.

(6) In regulation 63(49) (restriction notices) in paragraph (1)—

(i)in sub-paragraph (a), after “performance evaluation” insert “or study”;

(ii)in sub-paragraph (b), after “performance evaluation” insert “or study”.

(7) Omit regulation 65(centralised system of records etc.).

(8) In regulation 67(50) (review), for “2019” substitute “2025”.

(9) Omit Schedule 1(51) (association agreements).

(10) For Schedule 2(52) (mutual recognition agreements) substitute—

Regulation 1A

SCHEDULE 2Mutual Recognition Agreement countries

  • Australia

  • New Zealand

  • Canada

  • The United States of America

  • The Swiss Confederation.

PART 2New Part VIII of the Medical Devices Regulations

10.  After regulation 67 of the 2002 Regulations insert—

PART VIIIRestatement of the Rights, powers, liabilities, obligations, restrictions, remedies and procedures recognised under the Medical Devices Regulation (see regulation 4O)

Scope and Definitions

Subject matter and Scope

68.(1) This Part lays down the rules for and applies to the placing on the market, the making available on the market and the putting into service of—

(a)medical devices for human use; and

(b)accessories to such medical devices.

(2) This Part also applies to—

(a)clinical investigations concerning medical devices for human use and accessories to such devices; and

(b)the groups of products without an intended medical purpose listed in Schedule 16.

(3) Devices with both an intended medical and non-medical purpose must fulfil the requirements applicable to devices with an intended medical purpose and those applicable to devices without an intended medical purpose.

(4) For the purposes of this Part and Schedules 3 to 16 medical devices, accessories to medical devices and products listed in Schedule 16 are referred to as ‘devices’.

(5) The Secretary of State may by Regulations amend the list in Schedule 16.

(6) This Part does not apply to—

(a)relevant devices placed on the market in accordance with Part II or Part III;

(b)subject to paragraph (7), in vitro diagnostic medical devices placed on the market under Part IX;

(c)medicinal products as defined by regulation 2 of the Human Medicines Regulations 2012;

(d)advanced therapy medicinal products covered by regulation 2A of the Human Medicines Regulations 2012;

(e)human blood, human blood products, plasma or blood cells of human origin or devices which incorporate, when placed on the market or put into service, such blood products, plasma or cells except for devices referred to in paragraph (8);

(f)cosmetic products covered by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products;

(g)transplants, tissues or cells of animal origin or their derivatives, or products containing or consisting of them; but this Part does apply to devices which utilise tissues or cells of animal origin (or their derivatives) which are non-viable or rendered non-viable;

(h)transplants, tissues or cells of human origin, or their derivatives, covered by the Human Tissue (Quality and Safety for Human Application) Regulations 2007(53) or by the Human Fertilisation and Embryology Act 1990(54) or products containing or consisting of them but this Part does apply to devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable;

(i)products, other than those in paragraphs (e), (g) and (h), that contain or consist of viable biological material or viable organisms, including living micro-organisms, bacteria fungi or viruses in order to achieve or support the intended purposes of the product;

(j)food covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the principles and requirements of food law, establishing the European Food Safety Agency and laying down procedures in matters of food safety.

(7) Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device covered by Part IX, is governed by this Part but the requirements of Part IX also apply to the in vitro diagnostic medical device part of the device.

(8) Subject to sub-paragraph (9), any device which, when placed on the market or put into service, incorporates, as an integral part, a substance which, if used separately, would be considered a medicinal product (including a product derived from human blood or blood plasma) and that has an action ancillary to that of the device, must be assessed and authorised in accordance with this Part.

(9) If the action of the device is ancillary to that of the medicinal product, the product must be governed by the Human Medicines Regulations 2012.

(10) Where paragraph (9) applies, the general safety and performance requirements set out in Schedule 3 must also apply to the device part of the product.

(11) Subject to paragraph (12), any device which is intended to administer a medicinal product is governed by this Part without prejudice to the provisions of the Human Medicines Regulations 2012 .

(12) If the device intended to administer a medicinal product and the medicinal product are placed on the market in such a way that they form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single integral product must be governed by the Human Medicines Regulations 2012.

(13) Where paragraph (12) applies, the relevant general safety and performance requirements set out in Schedule 3 apply to the device part of the single integral product.

(14) A device which, when placed on the market, or put into service, incorporates, as an integral part, non-viable cells of human origin or their derivatives that have an action ancillary to that of the device must be assessed and authorised in accordance with this Part but the provisions for donation, procurement and testing laid down in the Human Tissue (Quality and Safety for Human Application) Regulations 2007 also apply.

(15) If a device which, when placed on the market, or put into service, incorporates, as an integral part, non-viable cells of human origin or their derivatives that have an action which is principal and not ancillary to that of the device and that product is not governed by the Human Medicines Regulations 2012, the product must be governed by the Human Tissue (Quality and Safety for Human Application) Regulations 2007 but the general safety and performance requirements set out in Schedule 3 also apply to the device.

(16) Where a device is also machinery within the meaning of the Supply of Machinery (Safety) Regulations 2008(55) and where—

(a)a hazard under that legislation exists; and

(b)the provisions of that legislation are more specific than the general safety and performance requirements set out in Schedule 3,

the device must also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008.

(17) This Part does not affect the application of the Ionising Radiation (Basic Safety Standards) (Miscellaneous Provisions) Regulations 2018(56) or any of the other measures which immediately before exit day transposed Council Directive 2013/59/Euratom(57) and which are retained EU law.

(18) This Part does not affect the power of the Secretary of State to restrict the use of any specific type of device in relation to aspects not covered by this Part.

(19) This Part does not affect the organisation, delivery or financing of health services and medical care including—

(a)the rules relating to the supply of medical devices on a medical prescription;

(b)requirements relating to—

(i)the dispensing of medical devices by healthcare institutions or healthcare professionals;

(ii)the use of certain medical devices being accompanied by specific professional counselling.

(20) This Part does not restrict the freedom of the press or freedom of expression in so far as those freedoms are guaranteed under the law.

Definitions

69.  In this Part and in Schedules 3 to 16—

“accessory for a medical device” means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical devices to specifically enable the medical device to be used in accordance with its intended purpose or to specifically and directly assist the medical functionality of the medical device in terms of its intended purpose;

“active device” means—

(a)

any device, which depends for its operation on a source of energy (other than that generated by the human body for that purpose, or by gravity) and which acts by changing the density of or converting that energy;

(b)

software;

but a device is not an active device if it is intended to transmit energy, substances or other elements between an active device and the patient without any significant change;

“adverse event” means any untoward occurrence, unintended disease or injury or any untoward clinical sign, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

“agglomerate”, in the definition of “nanomaterial”, means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the surface areas of the external components;

“aggregate”, in the definition of “nanomaterial”, means a particle comprised of strongly bound or fused particles;

“authorised health professional” has the same meaning as in regulation 2 of the Medicines for Human Use (Clinical Trials) Regulations 2004(58);

“authorised representative” means any person established outside the United Kingdom but within the European Economic Area who has received and accepted a written mandate from a manufacturer located outside the European Economic Area, to act on the manufacturer’s behalf in carrying out certain obligations under Regulation (EU) 2017/745;

“benefit-risk determination” means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;

“CE marking of conformity” or “CE marking” means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Part and with any other applicable legislation;

“clinical benefit” means the positive impact of the device on the health of an individual, expressed in terms of a measurable, meaningful and relevant clinical outcome, including outcomes related to diagnosis, or positive impact on patient management or public health;

“clinical data” means information concerning safety or performance that is generated from the use of a device and is sourced from the following—

(a)

clinical investigations of the device concerned;

(b)

clinical investigations or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated;

(c)

reports published in peer reviewed scientific literature on other clinical experience of either the device or a device for which equivalence to the device in question can be demonstrated;

(d)

clinically relevant information coming from post market surveillance, in particular the post-market clinical follow up;

“clinical evaluation” means a systematic investigation and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance including clinical benefits, of the device when used as intended by the manufacturer;

“clinical evidence” means clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits, when used as intended by the manufacturer;

“clinical investigation” mean a systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device;

“clinical investigation plan” means a document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation;

“clinical performance” means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;

“common specifications” or “CS” must be construed in accordance with regulation 75;

“compatibility” means the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose to do any or all of the following—

(a)

perform without losing or compromising the ability to perform as intended,

(b)

integrate or operate without the need for modification or adaptation of any part of the combined devices,

(c)

be used together without conflict, interference or adverse reaction;

“conformity assessment” means the process demonstrating whether the requirements of this Part have been fulfilled;

“conformity assessment body” means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

“corrective action” means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;

“custom-made device” means any device specifically made in accordance with a written prescription of a registered medical practitioner, or any other person authorised to write a prescription by virtue of their professional qualification which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual condition or need but the following devices are not custom-made devices—

(a)

mass-produced devices which need to be adapted to meet the specific requirements of a professional user, and

(b)

devices which are mass produced by means of an industrial manufacturing process in accordance with the written prescriptions of any authorised person;

“derivative” means a non-cellular substance which has been extracted from human or animal tissue or cells through a manufacturing process but where the final substance used for manufacturing of the device does not itself contain any cells or tissues;

“designated standard” has the same meaning as in regulation 3A;

“device deficiency” in relation to an investigational device means any inadequacy in its identity, quality, durability, reliability, safety or performance, including malfunction, use errors or inadequacy in information supplied by the manufacturer;

Directive 2001/83/EC” means Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(59) as it applies in European Union law;

“distributor” means any person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service;

“economic operator” means a manufacturer, an authorised representative, a UK responsible person, an importer, a distributor or a person referred to in regulation 87(1) and 87(4);

“ethics committee” means an independent body established or recognised under the Care Act 2014(60) and empowered to give opinions for the purposes of this Part;

“falsified device” means any device with a false presentation of its identity, of its source or its CE marking certificates or documents relating to CE marking procedures, but a device is not a falsified device where the false presentation is unintentional;

“field safety notice” means a communication sent by the manufacturer to users or customers in relation to field safety corrective action;

“field safety corrective action” means corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risk of serious incident in relation to a device made available on the market;

“fully refurbishing” (in the definition of “manufacturer”) means—

(a)

complete rebuilding of a device already placed on the market or put into service; or

(b)

the making of a new device from used devices, to bring it into conformity with this Part,

combined with the assignment of a new lifetime to the refurbished device;

“generic device group” means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

“health institution” means an organisation (based in the United Kingdom) the primary purpose of which is the care or treatment of patients or the promotion of public health;

“implantable device” means any device (including those which are wholly or partly absorbed) which is intended through clinical intervention—

(a)

to be totally introduced into the human body and to remain in place after the procedure;

(b)

to replace an epithelial surface or the surface of the eye and to remain in place after the procedure; or

(c)

to be partially introduced into the human body and to remain in place for at least 30 days after the procedure;

“importer” means any person established within the United Kingdom that places on the market a device from a country outside the United Kingdom;

“incident” in relation to a device made available on the market means any malfunction or deterioration in its characteristics or performance of a device, including use-error due to its ergonomic features, any inadequacy in the information supplied by the manufacturer and any undesirable side effects;

“informed consent” means a subject’s free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject’s decision to participate or, in the case of minors or incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation;

“instructions for use” means the information provided by the manufacturer to inform the user of the device’s intended purpose, proper use and of any precautions to be taken;

“intended purpose” means the use for which the device is intended as set out in—

(a)

the data supplied by the manufacturer on the label;

(b)

the instructions for use;

(c)

the promotional or sales material; or

(d)

promotional statements;

and as specified by the manufacturer in the clinical evaluation;

“interoperability” is the ability of two or more devices, including software from the same manufacturer or from different manufacturers, to do any or all of the following—

(a)

exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data;

(b)

communicate with each other;

(c)

work together as intended;

“invasive device” means any device which, in whole or in part, penetrates inside the body, either through a body orifice or through the surface of the body;

“investigational device” means a device that has been assessed in a clinical trial;

“investigator” means the individual responsible for the conduct of a clinical investigation at a clinical investigation site;

“label” means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

“lay person” means an individual who does not have formal education in the relevant field of healthcare or medical practice;

“legally designated representative”, has the meaning given to the term “legal representative” in Part 1 of Schedule 1(61) to the Medicines for Human Use (Clinical Trials) Regulations 2004;

“making available on the market” means any supply of a device, other than an investigational device, for distribution, consumption or use on the United Kingdom market in the course of a commercial activity, whether in return for payment or free of charge and related expressions must be construed accordingly;

“manufacturer” means a person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark;

“market surveillance” means the activities carried out and measures taken by the Secretary of State to check and ensure that devices comply with the requirements set out in this Part and do not endanger health safety or any other aspect of public interest protection;

“medical device” means—

(a)

any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes—

(i)

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

(ii)

diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

(iii)

investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

(iv)

providing information by means of in vitro examination of specimens derived from the human body, including organ, blood, and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means;

(b)

any device for the control or support of conception;

(c)

products specifically intended for the cleaning, disinfection or sterilisation of—

(i)

medical devices referred to in sub-paragraphs (a) and (b);

(ii)

accessories to medical devices; or

(iii)

products listed in Schedule 16;

“minor” means a person under the age of 16 years;

“nanomaterial” means—

(a)

natural, incidental or manufactured material containing particles in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1-100nm; or

(b)

fullerenes, graphene flakes and single wall carbon nanotubes with one of more external dimensions below 1nm;

“non-viable” means having no potential for metabolism or multiplication;

“notified body” means a conformity assessment body designated in accordance with Regulation (EU) 2017/745;

“particle”, in the definition of “nanomaterial”, means a minute piece of matter with defined physical boundaries;

“performance” means the ability of a device to achieve its intended purpose as stated by the manufacturer;

“placing on the market” means the first making available of a device, other than an investigational device, on the United Kingdom market and related expressions must be construed accordingly;

“post-market surveillance” means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purposes of identifying any need to immediately apply any necessary corrective or preventative actions;

“post market clinical follow-up” (PMCF) means a continuous process of updating the clinical evaluation;

“procedure pack” means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose;

“putting into service” means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the United Kingdom market for the first time for its intended purpose, and related expressions must be construed accordingly;

“recall” means any measure aimed at achieving the return of a device that has already been made available to the end user;

“Regulation (EU) 2017/745” means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC(62) as it has effect in European Union law;

“reprocessing” in relation to a used device means the process, including the cleaning disinfection, sterilisation and related procedures, and the testing and restoration of the technical and functional safety of the device, carried out in order to allow its safe reuse;

“risk” means the combination of the probability of occurrence of harm and the severity of that harm;

“serious adverse event” means any adverse event that led to any of the following—

(a)

death;

(b)

serious deterioration in the health of the subject, that resulted in any of the following—

(i)

life-threatening illness or injury,

(ii)

permanent impairment of a body structure or body function,

(iii)

hospitalisation or prolongation of hospitalisation,

(iv)

medical or surgical intervention to prevent life threatening illness or injury or permanent impairment to a body structure or body function,

(v)

chronic disease;

(c)

foetal distress, foetal death or congenital physical or mental impairment or birth defect;

“serious incident” means an incident that directly or indirectly led, might have led or might lead to any of the following—

(a)

the death of a patient, user or other person;

(b)

the temporary or permanent deterioration of a patient’s, user’s or other person’s state of health;

(c)

a serious public health threat;

“serious public health threat” means an event which could result in imminent risk of death, serious deterioration in the person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place or time;

“single-use device” means a device that is intended to be used on one individual during a single procedure;

“sponsor” means any person who takes responsibility for the initiation of the clinical investigation, the management of the clinical investigation and the setting up of the financing of the clinical investigation;

“subject” means the individual who participates in the clinical investigation;

“system” means a combination of products, whether or not they are packaged together, which are intended to be interconnected or combined to achieve a specific medical purpose;

“Unique Device Identifier” (‘UDI’) means a series of numeric or alphanumeric characters that is created through internationally recognised and accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;

“UDI system”, “UDI database” and related expressions have the meaning given in, or are to be construed in accordance with, in Part C of Schedule 8;

“UK responsible person” has the same meaning as in regulation 2;

“user” means a healthcare professional or lay person who uses a device;

“withdrawal” means any measure aimed at preventing a device in the supply chain from being made available on the market.

Regulatory status of products and amendment of definitions

70.(1) Subject to paragraph (3), the Secretary of State may by regulations determine whether or not a specific product, or category or group of products, falls within the definition of a medical device or an accessory to a medical device.

(2) The Secretary of State may by regulations amend the definition of “nanomaterial” and associated definitions in regulation 69—

(a)in the light of technical and scientific progress; and

(b)taking into account definitions agreed at international level.

(3) Before making regulations under paragraph (1), the Secretary of State must consult such persons, agencies or bodies as the Secretary of State considers it appropriate to consult.

Making available on the market and putting into service of devices, obligations of economic operators. Reprocessing, CE marking, Free Movement

Placing on the market and putting into service

71.(1) A device to which this Part applies may be placed on the market or put into service only if it complies with this Part when duly supplied and properly installed, maintained and used in accordance with its intended purpose.

(2) A device to which this Part applies must meet the general safety and performance requirements set out in Schedule 3 which apply to it, taking into account its intended purpose.

(3) Demonstration of the general safety and performance requirements must include a clinical evaluation in accordance with regulation 102.

(4) Devices that are manufactured and used within health institutions must be considered as having been put into service.

(5) With the exception of the relevant safety and performance requirements set out in Schedule 3, the requirements of this Part do not apply to a device which is manufactured and used only within health institutions provided that—

(a)the device is not transferred to another legal entity;

(b)manufacture and use of the device occurs under appropriate quality management systems;

(c)the health institution justifies in its documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance, by an equivalent device available on the market;

(d)on request from the Secretary of State, the health institution provides the Secretary of State with information (which must include justification for its manufacturing, modification and use of such devices) on the use of the devices;

(e)the health institution draws up and makes publically available a statement setting out—

(i)the name and address of the manufacturing health institution,

(ii)the details necessary to identify the devices,

(iii)a declaration that the devices meet the general safety and performance requirements set out in Schedule 3 or, where applicable, information on which requirements are not fully met and a reasoned justification for not meeting those requirements;

(f)the health institution draws up a document which makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices and the intended purpose, and which is sufficiently detailed to enable the Secretary of State to ascertain whether the general safety and performance requirements set out in Schedule 3 are met;

(g)the health institution takes all necessary measures to ensure that the device is manufactured in accordance with the documentation referred to in sub-paragraph (f);

(h)the health institution reviews experience gained from the clinical use of the devices and takes all necessary corrective actions.

(6) The Secretary of State may require a health institution which has complied with paragraph (5) to provide the Secretary of State with any further information about the devices which it has manufactured or used.

(7) The Secretary of State may restrict the manufacture and the use of a specified type of device manufactured in accordance with paragraph (5) and, for the purpose of considering such a restriction, must be permitted access to inspect the activities of health institutions.

(8) Paragraph (5) does not apply to devices that are manufactured on an industrial scale.

Distance Sales

72.(1) A device offered by means of information society services to a person established in the United Kingdom must comply with this Part.

(2) A device which is—

(a)not placed on the market;

(b)used for the provision of a diagnostic or therapeutic service used in the context of a commercial activity, whether in return for payment or free of charge; and

(c)offered by means of information society services or by other means of communication (whether directly or through intermediaries) to a person in the United Kingdom,

must comply with this Part.

(3) The Secretary of State may require a person offering a device, as described in paragraph (1) or providing a service described in paragraph (2), to provide the Secretary of State with a copy of the declaration of conformity relating to the device.

(4) In this regulation “information society service” means a “service” within the meaning of Article 1(1)(b) of Directive 2015/1535/EU of the European Parliament and of the Council of 9 September 2015(63) (as it has effect in European Union law).

Claims

73.  In the labelling, instructions for use, making available, putting into service or advertising of a device a person must not use text, names, trademarks, pictures, figurative or other signs that may mislead the user or the patient with regard to the device’s intended purpose, safety or performance by—

(a)ascribing functions and properties to a device which the device does not have;

(b)creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c)failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; or

(d)suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Use of designated standards

74.(1) Devices that are in conformity with the designated standards, or the relevant parts of those standards, are presumed to be in conformity with the requirements of this Part covered by those standards or relevant parts of those standards.

(2) Paragraph (1) also applies to system or process requirements to be fulfilled in accordance with this Part by economic operators or sponsors, including those relating to quality management systems, risk management, post market surveillance systems, clinical investigations, clinical evaluation or post-market clinical follow up (‘PMCF’).

Common Specifications

75.(1) Subject to paragraphs (5) and (6), in this Part “common specifications” (CS) means common specifications which are—

(a)adopted by the European Commission in accordance with the procedure set down in Article 9(1) of Regulation (EU) 2017/745; and

(b)designated by the Secretary of State by publishing a reference to the CS and maintaining that publication in a manner in which the Secretary of State considers appropriate.

(2) Devices that comply with CS adopted in accordance with paragraph (1) or specified in regulations made under paragraph (6), are presumed to be in conformity with the requirements of this Part covered by CS or the relevant parts of the CS.

(3) Manufacturers must comply with CS adopted in accordance with paragraph (1), or specified in regulations made under paragraph (6), unless they can justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent to the CS.

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw CS to the attention of any person who may have an interest in the CS.

(5) The Secretary of State may cancel the designation of CS by removing from publication the reference to the CS published in accordance with paragraph (1)(b) and, where the Secretary of State has done so, that CS is no longer a CS.

(6) Where the European Commission have not adopted a common specification but the Secretary of State is of the opinion that a common specification is necessary to address urgent public health concerns, the Secretary of State may by regulations specify a CS and publish the CS and designate it in accordance with paragraph (1)(b).

General obligations of manufacturers

76.(1) When placing devices on the market or putting them into service, manufacturers must ensure that they have been designed and manufactured in accordance with the requirements of this Part.

(2) Manufacturers must establish, document, implement and maintain a system for risk management as described in paragraph 3 of Schedule 3.

(3) Manufacturers must conduct a clinical evaluation in accordance with the requirements set out in regulation 102 and Schedule 14 including PMCF.

(4) Manufacturers of devices other than custom-made devices must draw up and keep up to date technical documentation for those devices.

(5) The technical documentation in paragraph (4) must—

(a)be such as to allow the conformity of the device with the requirements of this Part to be assessed;

(b)include the elements set out in Schedules 4 and 5.

(6) Where the Secretary of State considers it necessary in the light of technical progress, the Secretary of State may by regulations amend Schedules 4 and 5.

(7) Manufacturers of custom-made devices must draw up, keep up to date and keep available for the Secretary of State documentation in accordance with paragraph 12(2) of Schedule 13.

(8) Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, must draw up a declaration of conformity in accordance with regulation 84, and affix the CE marking of conformity in accordance with regulation 85.

(9) Manufacturers must comply with the obligations relating to the UDI system referred to in regulation 91 and with the registration obligations referred to in regulations 93 and 95.

(10) Manufacturers must keep the technical documentation, the declaration of conformity and, if applicable, a copy of any relevant certificate (including amendments and supplements), available for the Secretary of State—

(a)in the case of implantable devices for a period of at least 15 years after the last device covered by the declaration of conformity has been placed on the market;

(b)in the case of all other devices, for a period of at least 10 years after the last device covered by the declaration of conformity has been placed on the market.

(11) The Secretary of State may require a manufacturer to provide the technical documentation and such a request may be for the entirety of the documentation or for a summary.

(12) A manufacturer with a registered place of business outside the United Kingdom must ensure that the person responsible for placing the device on the United Kingdom market has the necessary documentation permanently available.

(13) Manufacturers must ensure that procedures are in place to keep series production in conformity with the requirements of this Part including—

(a)ensuring that changes in device design or characteristics and changes in the designated standards or CS by reference to which the conformity of the device is declared are adequately, and in a timely manner, taken into account;

(b)ensuring that for devices (other than investigational devices) a quality management system, which is proportionate to the risk class and type of device is established, documented, implemented, maintained, kept up to date and continually improved.

(14) The quality management system required by paragraph (13) must—

(a)cover all parts and elements of the manufacturer’s organisation dealing with the quality of processes, procedures and devices;

(b)govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Part;

(c)provide details of at least the following—

(i)a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

(ii)the identification of applicable general safety and performance requirements and exploration of options to address those requirements;

(iii)the responsibility of the management;

(iv)resource management, including selection and control of suppliers and sub-contractors;

(v)risk management as set out in paragraph 3 of Schedule 3;

(vi)clinical evaluation in accordance with regulation 102 and Schedule 14, including PMCF;

(vii)product realisation, including planning, design, development, production and service provision;

(viii)verification of the UDI assignments made in accordance with regulation 91 to all relevant devices and ensuring consistency and validity of information provided in accordance with regulation 93;

(ix)setting-up, implementation and maintenance of a post-market surveillance system, in accordance with regulation 121;

(x)processes for handling communication with the Secretary of State (and authorities in other relevant states), notified bodies, other economic operators, customers and any other stakeholders;

(xi)processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;

(xii)management of corrective and preventive actions and verification of their effectiveness;

(xiii)processes for monitoring and measurement of output, data analysis and product improvement.

(15) Manufacturers must implement and keep up to date the post market surveillance system in accordance with regulation 121.

(16) Manufacturers must ensure that—

(a)the device is accompanied by the information set out in paragraph 23 of Schedule 3;

(b)the particulars on the label are indelible, easily legible and clearly comprehensible to the intended user or patient.

(17) Manufacturers who consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Part must—

(a)immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate;

(b)inform the distributors of the device in question and, where applicable, the authorised representative, the UK responsible person and importers accordingly;

(c)where the device presents a serious risk, immediately inform the Secretary of State and, where applicable, the notified body that issued a certificate for the device, in particular, of the non-compliance and of any corrective action taken.

(18) Manufacturers must have a system for recording and reporting incidents and field safety corrective actions as described in regulation 125 and regulation 126.

(19) Manufacturers must, when they are required to do so by the Secretary of State in relation to a device—

(a)provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of the device;

(b)cooperate with the Secretary of State on any corrective action to be taken to eliminate or, if that is not possible, mitigate the risks posed by the device which they have placed on the market or put into service;

(c)provide samples of the device free of charge or, where that is impracticable, grant access to the device.

(20) A manufacturer who fails to cooperate with a requirement made under paragraph (19) may be subject to enforcement action under Part VII or to any other enforcement measures available to the Secretary of State under consumer protection legislation.

(21) Subject to the Data Protection Act 2018(64) and to the protection of any intellectual property rights, the Secretary of State must, where there is reason to believe that a device has caused damage and where a request is made in writing by a person in sub-paragraph (a), (b) or (c) facilitate the provision of the information and documentation mentioned in paragraph (19) to—

(a)any person who has been or could have been injured by the device;

(b)any person entitled to bring an action on behalf of the person in sub-paragraph (a); or

(c)any other person reasonably believed to have been affected by the damage caused by the device.

(22) The Secretary of State need not comply with paragraph (21) where disclosure of the information and documentation is to be dealt with in legal proceedings.

(23) Where a manufacturer has entered into an arrangement with another person to design or manufacture a device, the identity of that other person must form part of the information submitted in accordance with regulation 95.

(24) Manufacturers must, taking account of the risk class of a device and the type of device which they produce and the size of their enterprise, hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability arising from damage caused by each such device.

UK responsible person

77.  A person regarded as the UK responsible person must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d)forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples or has been given access to the device;

(e)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(f)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(g)terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

General obligations of importers

78.(1) Importers must only place devices on the market which are in conformity with this Part.

(2) In order to place a device on the market, importers must ensure that—

(a)the device has been CE marked and that the declaration of conformity of the device has been drawn up;

(b)its manufacturer or, if applicable its authorised representative, is identified;

(c)the device is labelled in accordance with this Part and accompanied by the required instructions for use;

(d)where applicable, a UDI has been assigned by the manufacturer in accordance with regulation 91.

(3) Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Part, the importer—

(a)must not place the device on the market until it has been brought into conformity; and

(b)must inform the manufacturer.

(4) Where an importer considers or has reason to believe that a device presents a serious risk or is a falsified device, the importer must also inform the Secretary of State.

(5) Importers must indicate on the device or on its packaging or in a document accompanying the device—

(a)their name,

(b)if applicable, their registered trade name or registered trade mark,

(c)if applicable, their registered place of business or the address at which they can be contacted.

(6) Importers must ensure that any additional label does not obscure information on the label provided by the manufacturer.

(7) Importers must verify that the device has been registered with the Secretary of State and must add their name to the registration.

(8) Importers must—

(a)ensure that while a device is under their responsibility, storage or transport conditions do not jeopardise a device’s compliance with the general safety and performance requirements set out in Schedule 3;

(b)comply with any conditions set by the manufacturer.

(9) Importers must keep a register of—

(a)complaints about devices;

(b)non-conforming devices;

(c)recalls of devices;

(d)withdrawals of devices;

and must provide the manufacturer or distributor with any information reasonably requested by them in order to allow them to investigate complaints.

(10) Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Part must—

(a)inform the manufacturer and, if applicable, the authorised representative and the UK responsible person;

(b)cooperate with the manufacturer and the Secretary of State to ensure the necessary corrective action to bring the device into conformity, to withdraw or recall it, is taken.

(11) Where a device presents a serious risk, importers must immediately inform the Secretary of State and, if applicable, the notified body that issued the certificate and must give details of the non-compliance giving rise to the risk and of any corrective action.

(12) Importers who receive complaints from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market must immediately inform the manufacturer and if applicable the authorised representative and the UK responsible person.

(13) Importers must keep the declaration of conformity and any relevant certificate for the period referred to in regulation 76(10).

(14) Importers must, if required by the Secretary of State to do so—

(a)cooperate with the Secretary of State on any action to eliminate or, if that is not possible, mitigate the risks posed, by devices which they have placed on the market;

(b)provide samples of a device or, if that is impractical, grant the Secretary of State access to the device.

General obligations of distributors

79.(1) When making a device available on the market, distributors must, in the context of their activities, comply with the requirements of this Part.

(2) Before making a device available on the market, distributors must ensure that all the following requirements are met—

(a)the device has been CE marked and the declaration of conformity of the device has been drawn up;

(b)the device is accompanied by the information supplied by the manufacturer in accordance with regulation 76(16);

(c)for imported devices, the importer has complied with the requirements set out in regulation 78(5);

(d)that, where applicable, a UDI has been assigned by the manufacturer.

(3) In order to meet the requirements of sub-paragraphs (a), (b) and (d) of paragraph (2) the distributor may apply a sampling method that is representative of the devices supplied by the distributor.

(4) Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Part, the distributor must—

(a)not make the device available on the market until it has been brought into conformity;

(b)inform the manufacturer;

(c)where applicable, inform the importer, the authorised representative and the UK responsible person.

(5) Where a distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, the distributor must, in addition to complying with paragraph (4) also inform the Secretary of State.

(6) Distributors must ensure that, while the device is under their responsibility, storage and transport conditions comply with the conditions set by the manufacturer.

(7) Where a distributor considers or has reason to believe that a device which that distributor has made available on the market is not in conformity with this Part, the distributor must—

(a)inform the manufacturer and where applicable, the manufacturer’s authorised representative, the UK responsible person and the importer;

(b)cooperate with the manufacturer and with the Secretary of State and, where applicable, the manufacturer’s authorised representative, UK responsible person and the importer to ensure the necessary corrective action to bring the device into conformity, to withdraw or to recall the device, is taken.

(8) Where the distributor considers or has reason to believe that a device which it has made available on the market presents a serious risk it must immediately inform the Secretary of State.

(9) Distributors must, unless the relevant information will be provided by another economic operator, upon request by the Secretary of State, provide the Secretary of State with all the information at their disposal and necessary to demonstrate the conformity of the device.

(10) Distributors must, at the Secretary of State’s request—

(a)cooperate with the Secretary of State on any action taken to eliminate the risks posed by devices which they have made available on the market;

(b)provide free samples of the device or, if that is impractical, grant the Secretary of State access to the device.

Person responsible for regulatory compliance

80.(1) Subject to paragraph (4), manufacturers must have available within their organisation at least one person who is responsible for regulatory compliance and who possesses the requisite expertise in the field of medical devices.

(2) Subject to paragraph (3), the requisite expertise in paragraph (1) may be demonstrated by either of the following—

(a)a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised by the Secretary of State as equivalent in—

(i)law,

(ii)medicine,

(iii)pharmacy,

(iv)engineering, or

(v)another relevant scientific discipline,

and at least one year of professional experience in regulatory affairs management relating to medical devices;

(b)4 years of professional experience in—

(i)regulatory affairs, or

(ii)in quality management systems relating to medical devices.

(3) Where a manufacturer manufactures custom-made devices the requisite experience may be demonstrated by having at least 2 years of professional expertise within a relevant field of manufacturing.

(4) Micro and small businesses, within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises(65) (as it has effect in European Union law), are not required to have a person responsible for regulatory compliance within their organisation but must have such a person permanently and continuously at their disposal.

(5) The person responsible for regulatory compliance must at least be responsible for ensuring that—

(a)the conformity of devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before the device is released;

(b)the technical documentation and declaration of conformity are drawn up and kept up-to date;

(c)the post market surveillance obligations are complied with in accordance with regulation 76(15);

(d)the reporting obligations referred to in regulations 125 to 128 are fulfilled;

(e)in the case of investigational devices, the statement referred to in paragraph 4(1) of Chapter II of Schedule 15 is issued.

(6) If a number of persons are jointly responsible for regulatory compliance their respective areas of responsibility must be stipulated in writing.

(7) The person responsible for regulatory compliance must not suffer any disadvantage within the manufacturer’s organisation in relation to the person’s proper fulfilment of their duties, regardless of whether or not they are employees of the organisation.

Cases in which obligations of manufacturers apply to importers, distributors or other persons

81.(1) A distributor, importer or other person has the obligations of a manufacturer if that person does any of the following—

(a)makes available on the market a device under its name, registered trade name or registered mark, except in cases where a distributor or importer enters into an agreement with manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Part;

(b)changes the intended purpose of a device already placed on the market or put into service;

(c)modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.

(2) Paragraph (1) does not apply to a person who, without changing its intended purpose, assembles or adapts for an individual patient a device which is already on the market.

(3) For the purposes of paragraph (1)(c) the following are not to be considered to be a modification of a device that could affect its compliance with the applicable requirements—

(a)provision of information supplied by the manufacturer, in accordance with paragraph 23 of Schedule 3, relating to a device already on the market and of further information which is necessary in order to market the device;

(b)changes to the outer packaging of a device already placed on the market, including a change of the pack size, if the repackaging is carried out in such conditions that the original condition of the device cannot be affected but, for devices placed on the market in a sterile condition, the original condition of the device must be presumed to be adversely affected if the packaging necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.

(4) A distributor or importer that carries out any of the activities mentioned in paragraph (3) must indicate on the device or, where that is impractical, on the packaging or in a document accompanying the device—

(a)the activity carried out;

(b)the name of the importer or distributor;

(c)any registered trade name or trade mark of the importer or distributor;

(d)the registered place of business and the address at which the importer or distributor can be contacted.

(5) Distributors and importers who carry out the activities in paragraph (3) must have a quality management system in place which—

(a)ensures that the activities in paragraph (3) are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy;

(b)contains procedures which ensure that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in order to respond to safety issues or to bring the device into conformity with this Part.

(6) At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities in paragraph (3) must—

(a)inform the manufacturer and the Secretary of State of the intention to make a relabelled or repackaged device available;

(b)upon request, provide the manufacturer and the Secretary of State with a sample or mock-up of the relabelled or repackaged device (including any translated label and instructions for use);

(c)submit to the Secretary of State a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in paragraph (3), attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraph (4).

Single-use devices and their reprocessing

82.(1) Reprocessing and further use of single-use devices may only take place in accordance with this Part.

(2) Subject to paragraph (4), any person who reprocesses a single-use device to make it suitable for further use must be considered a manufacturer of the reprocessed device and must assume the obligations of a manufacturer in this Part.

(3) A person who reprocesses a device must be considered to be the producer for the purposes of Part I of the 1987 Act.

(4) Where single-use devices are reprocessed and used within a health institution, the Secretary of State may direct that not all the rules relating to manufacturers obligations laid down in this Part apply provided that the following conditions are met—

(a)the safety and performance of the reprocessed device is equivalent to that of the original device and the requirements of regulation 71(5) are complied with;

(b)the reprocessing is performed in accordance with the CS detailing requirements concerning—

(i)risk management, including the analysis of the construction and material, related properties of the device (reverse engineering) and procedures to detect changes in the design of the original device as well as of its planned application after reprocessing;

(ii)the validation of procedures for the entire process, including cleaning steps;

(iii)the product release and performance testing;

(iv)the quality management system;

(v)the reporting of incidents involving devices that have been reprocessed; and

(vi)the traceability of reprocessed devices.

(5) The Secretary of State must encourage and may require health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other information on the reprocessed devices that patients are treated with.

(6) The Secretary of State may also direct that the provisions of paragraph (4) apply where single-use devices are processed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to the health institution and the external reprocessor complies with the requirements of paragraph (4).

(7) Reprocessing of devices may only be performed in accordance with any designated standards that cover the matters outlined in paragraph (4)(b) and may not be performed unless such designated standards have been adopted.

(8) Only single-use devices that have been placed on the market in accordance with Part II or this Part of these Regulations may be reprocessed.

(9) Only reprocessing of single-use devices that are considered safe according to the latest scientific evidence may be carried out.

(10) The name and address of the person referred to in paragraph (2) and the other relevant information referred to in paragraph 23 of Schedule 3 must be indicated on the label and, where applicable, in the instructions for use of the reprocessed device.

(11) The name and address of the manufacturer of the original single-use device must no longer appear on the label, but must be mentioned in the instructions for use of the reprocessed device.

Implant card and information to be supplied to the patient with an implanted device

83.(1) The manufacturer of an implantable device must provide, together with the device, the following—

(a)information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer;

(b)any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions;

(c)any information about the expected lifetime of the device and any necessary follow-up;

(d)any other information to ensure safe use of the device by the patient, including the information in paragraph (u) of sub-paragraph (6) of paragraph 23 of Schedule 3.

(2) The information referred to in paragraph (1)—

(a)must be provided, for the purpose of making it available to the particular patient who has been implanted with the device, by means that allow rapid access to the information;

(b)must be written in a way that is readily understood by a lay person and must be updated where appropriate, such updates being made available to the patient on the manufacturer’s website;

(c)for the information referred to in paragraph (1)(a), must be on an implant card delivered with the device.

(3) Health institutions must—

(a)make the information referred to in paragraph (1) available by means which allow rapid access to that information, to any patients who have been implanted with the device,

(b)provide those patients with the implant card.

(4) The requirements of this regulation do not apply to the following implants—

(a)Sutures;

(b)Staples;

(c)dental fillings;

(d)dental braces;

(e)tooth crowns;

(f)screws;

(g)wedges;

(h)plates;

(i)wires;

(j)pins;

(k)clips;

(l)connectors.

(5) The Secretary of State may, by regulations, amend the list in paragraph (4) by adding other types of implants to it or by removing implants from the list.

Declaration of conformity

84.(1) The declaration of conformity must state that the requirements specified in this Part or, where relevant, in Regulation (EU) 2017/745 or both sets of requirements, have been fulfilled in relation to the device that is covered.

(2) The manufacturer must continuously update the declaration of conformity and the declaration of conformity must—

(a)contain the information set out in Schedule 6;

(b)be in English.

(3) Where a device is subject to other legislation which requires a declaration of conformity by the manufacturer, a single declaration of conformity must be drawn up in respect of all the legislation applicable to the device and must contain the information required for identification of the legislation to which the declaration relates.

(4) By drawing up the declaration of conformity, the manufacturer assumes responsibility for compliance with the requirements of this Part and all other legislation applicable to the device.

CE marking of conformity

85.(1) Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Part must bear the CE marking of conformity set out in Schedule 7.

(2) The CE marking—

(a)must be affixed visibly, legibly and indelibly to the device or its sterile packaging;

(b)where such affixing is not possible or not warranted on account of the nature of the device, must be affixed to the packaging;

(c)must also appear in any instructions for use and on any sales packaging.

(3) The CE marking must be affixed before the device is placed on the market and may be followed by a pictogram or any other mark indicating a special risk or use.

(4) Where applicable, the CE marking must be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in regulation 98 and the identification number must also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.

(5) Where devices are subject to other legislation which also provides for the affixing of the CE marking, the CE marking must indicate that the devices also fulfil the requirements of that other legislation.

Devices for special purposes

86.(1) The Secretary of State must not create obstacles to—

(a)investigational devices being supplied to an investigator for the purpose of a clinical investigation if they meet the requirements of this Part;

(b)custom made devices which meet the requirements of this Part.

(2) Other than investigational devices which already bear a CE marking, the devices to which paragraph (1) relates must not bear a CE marking.

(3) Custom-made devices must be accompanied by the statement referred to in paragraph 1 of Schedule 13 which must be identified by name, an acronym or a numerical code.

(4) The Secretary of State may require a manufacturer of a custom-made device to send to the Secretary of State a list of such devices.

(5) The Secretary of State must not create obstacles to the showing of devices, which do not comply with this Part, at trade fairs, exhibitions, demonstrations or similar events provided that the following conditions are met—

(a)a visible sign clearly indicates that such a device is intended for presentation or demonstration purposes;

(b)that such a device cannot be made available until it has been brought into compliance with this Part.

System and procedure packs

87.(1) A person who combines devices bearing a CE mark with other devices or products listed in paragraph (2), in a manner that is compatible with the intended purpose of the devices or other products and within the limits specified by their manufacturer, for the purpose of placing them on the market as a system or procedure pack, must draw up a statement.

(2) The devices or other products mentioned in paragraph (1) are—

(a)other devices bearing the CE marking;

(b)in vitro diagnostic medical devices bearing the CE marking in conformity with Part IX;

(c)other products which conform with legislation that applies to them only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.

(3) In the statement required by paragraph (1), the person must declare that—

(a)they have verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturer’s instructions and have carried out their activities in accordance with those instructions;

(b)they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;

(c)the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.

(4) Any person who sterilises system or procedure packs referred to in paragraph (1) for the purpose of placing them on the market, may apply either the procedure set out in Schedule 10 or the procedure set out in Part A of Schedule 12 and must draw up a statement declaring that the sterilisation has been carried out in accordance with the manufacturer’s instructions.

(5) Where —

(a)a system or procedure pack consists of devices or products which do not bear the CE marking;

(b)the chosen combination of devices is not compatible (having regard to their original intended purpose); or

(c)sterilisation has not been carried out in accordance with the manufacturer’s instructions the system or procedure pack must be treated as a device in its own right, must be subject to the relevant conformity assessment procedure in regulation 98 and the person who creates the system or procedure pack must assume the obligations of a manufacturer.

(6) The system or procedure packs referred to in paragraph (1)—

(a)must not themselves bear an additional CE marking;

(b)must bear the name, registered trade name or registered trade mark and the address of the person intending to place a system or procedure pack on the market in accordance with paragraphs (1) or (3);

(c)must be accompanied by the information referred to in paragraph 23 of Schedule 3.

(7) The statement referred to in paragraph (2) must be kept, in respect of the devices which have been combined, at the disposal of the Secretary of State for the period specified in regulation 76(10) and, where different periods would apply to different devices within the system or procedure pack, the longest period must apply.

Parts and components

88.(1) Any person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, must—

(a)ensure that the item does not adversely affect the safety and performance of the device; and

(b)keep available supporting evidence of that for the Secretary of State.

(2) An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device is considered to be a device and must meet the requirements laid down in this Part.

Identification and traceability of devices, registration of devices and of economic operators, summary of safety and performance and clinical performance

Identification within the supply chain

89.(1) Distributors and importers must cooperate with manufacturers (or, if applicable, the manufacturer’s authorised representative and UK responsible person) to achieve an appropriate level of traceability of devices.

(2) Economic operators must, where applicable, be able to identify the following to the Secretary of State, for the period referred to in regulation 76(10)—

(a)any economic operator to whom they have directly supplied a device;

(b)any economic operator who has directly supplied them with a device;

(c)any health institution or healthcare professional to which they have directly supplied a device.

Medical devices nomenclature

90.(1) The Secretary of State must ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other persons required by this Part to use that nomenclature.

(2) The Secretary of State must also endeavour to ensure that nomenclature is available to other stakeholders free of charge, where reasonably practicable.

Unique device identification system

91.(1) ‘UDI system’ must consist of –

(a)production of a UDI that comprises—

(i)a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Schedule 8;

(ii)a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Schedule 8;

(b)placing of the UDI on the label of the device or on its packaging;

(c)storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs (8) and (9) of this regulation respectively;

(d)establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with regulation 94.

(2) Before placing a device, other than a custom-made device, on the market, the manufacturer must assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of an issuing entity.

(3) Before a device, other than a custom-made or investigational device, is placed on the market the manufacturer must ensure that the information referred to in Part B of Schedule 8 about the device is correctly submitted and transferred to the UDI database referred to in regulation 94.

(4) UDI carriers must be placed on the label of the device and on all higher levels of packaging but “higher levels of packaging” does not include shipping containers.

(5) The UDI must be used for reporting serious incidents and field safety corrective actions in accordance with regulation 125.

(6) The Basic UDI-DI of the device must appear on the declaration of conformity referred to in regulation 84.

(7) As part of the technical documentation referred to in Schedule 4 the manufacturer must keep up-to-date a list of the UDIs that it has assigned.

(8) Economic operators must store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to—

(a)Class III implantable devices;

(b)the devices, categories or groups of devices determined by regulations made under paragraph (12)(a).

(9) Health institutions must store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices are Class III implantable devices.

(10) For devices other than Class III implantable devices, the Secretary of State may require, health institutions to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.

(11) The Secretary of State may require healthcare professionals to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.

(12) The Secretary of State may by regulations—

(a)determine the devices, categories or groups of devices mentioned in paragraph (8);

(b)amend the list of information set out in Part B of Schedule 8 in the light of technical progress;

(c)amend Schedule 8 in the light of international developments and technical progress.

(13) In this regulation, regulation 93 and Schedule 8 “issuing entity” means an organisation designated by the European Commission for the purpose of issuing UDIs pursuant to Regulation (EU) 2017/745.

UDI database

92.(1) The Secretary of State must set up and manage a UDI database to validate, collate, process and make available to the public the information mentioned in Part B of Schedule 8.

(2) The UDI database may be a separate database or form part of a larger database which may include the system required by regulation 94.

(3) In designing the UDI database, the Secretary of State must—

(a)take into account the general principles set out in paragraph 5 of Part C Schedule 8;

(b)ensure that UDI-PIs and commercially confidential product information cannot be included in the database.

(4) The core data elements to be provided to the UDI database, referred to in Part B of Schedule 8 must be accessible to the public free of change.

(5) The technical design of the UDI database must ensure maximum accessibility to information, including multi-user access and automatic uploads and downloads of that information.

(6) The Secretary of State must provide for technical and administrative support to manufacturers and other users of the UDI database.

(7) The UDI database must also be set up to manage the information and core data elements in respect of devices falling under Part IX.

Registration of devices

93.(1) Before placing a device, other than a custom-made device, on the market, the manufacturer must, in accordance with the rules of the issuing entity referred to in regulation 91(13), assign a Basic UDI-DI, as defined in Part C of Schedule 8, to the device and must provide it to the Secretary of State together with the other core data elements referred to in—

(a)Part B of Schedule 8 related to that device;

(b)Paragraph 2 in Part A of Schedule 8.

(2) Before placing on the market a system or procedure pack pursuant to regulation 87(1) and (4), that is not a custom-made device, the person responsible must assign to the system or procedure pack, in compliance with the rules of the issuing entity, a Basic UDI-DI and must provide it to the UDI database together with the other core data elements referred to in Part B of Schedule 8 related to that system or procedure pack.

(3) Where a manufacturer is not established in the United Kingdom, the UK responsible person must ensure that the manufacturer has complied with paragraphs (1) or (2).

Electronic system for registration of devices and economic operators

94.  The Secretary of State must set up and manage an electronic system to—

(a)create a registration number for the purpose of identifying the manufacturer and, where applicable, the importer, authorised representative, the UK responsible person and distributor; and

(b)register the information provided for in paragraph 1 and paragraph 2 (with the exception of paragraph 2(b)) of Part A of Schedule 8.

Registration of economic operators

95.(1) No person may place a device, other than a custom made device, on the market, unless that person is—

(a)established in the United Kingdom;

(b)has complied with paragraph (2).

(2) Before placing a device, other than a custom made device, on the market—

(a)a manufacturer, falling within paragraph (1)(a), must register with the electronic system referred to in regulation 94 and provide the information set out in paragraph 1 of Part A of Schedule 8;

(b)where there is no manufacturer established in the United Kingdom, the person placing the product on the market is to be regarded as the UK responsible person and that person must register with the electronic system referred to in regulation 94 and provide the information set out in paragraph 1 of Part A of Schedule 8.

(3) Unless they have already registered as a person within paragraph (2)(b), importers must also provide the relevant information in paragraph 1 of Part A of Schedule 8.

(4) Within one week of a change occurring in the information referred to in paragraph (2), the person providing the relevant information in accordance with paragraphs (2) or (3) must update the information in the electronic system referred to in regulation 94.

(5) Not later than one year after the submission of the information referred to in paragraph (2), and every second year after that, the person must confirm the accuracy of the information.

(6) Notwithstanding the person’s responsibility for the accuracy of the information, the Secretary of State must verify the information provided under paragraph (2).

(7) The information entered in the electronic system must be accessible to the public.

(8) The Secretary of State may use the information provided under paragraph (2) for the purpose of charging a fee in connection with carrying out the activities set out in this Part.

Summary of safety and clinical performance

96.(1) For implantable devices and for Class III devices, other than custom-made or investigational devices, a manufacturer must draw up a summary of safety and clinical performance.

(2) The summary of safety and clinical performance must be written in a way that is clear to the intended user and, if applicable, to the patient and must be made available to the public.

(3) The manufacturer must state on the label or the instructions for use where the summary of safety and clinical performance can be found.

(4) The summary of safety and clinical performance must include at least the following—

(a)identification of the device and the manufacturer including the Basic UDI-DI;

(b)the intended purpose of the device, any indications or contraindications and the target populations;

(c)a description of the device, including a reference to any previous generations or variants and a description of the differences;

(d)where relevant, a description of any accessories, other devices and products which are intended to be used in combination with the device;

(e)possible diagnostic therapeutic alternatives;

(f)the summary of clinical evaluation as referred to in Schedule 14, and relevant information on post-market clinical follow-up;

(g)suggested profile and training for users;

(h)information on any residual risks and any undesirable side effects, warnings and precautions.

(5) The Secretary of State may by regulations set out the form and presentation of the data elements to be included in the summary of safety and clinical performance.

Classification and conformity assessment

Classification of devices

97.  Devices must be divided into Classes I, IIa, IIb and III according to the classification rules in Schedule 9.

Conformity assessment procedures

98.(1) Subject to regulation 100, before placing a device on the market, putting a device into service or making a device available on the market, a person must ensure that the manufacturer has undertaken an assessment of the conformity of the device in accordance with the applicable conformity assessment procedures outlined in paragraphs (2) to (10) and set out in Schedules 10 to 12.

(2) Class III devices, other than custom-made or investigational devices, must be subject to—

(a)a conformity assessment as specified in Chapters I and III of Schedule 10; or

(b)a conformity assessment as specified in Schedule 11 coupled with a conformity assessment as specified in Schedule 12.

(3) Subject to paragraph (4), Class IIb devices, other than customer-made or investigational devices, must be subject to a conformity assessment—

(a)as specified in Chapters I and III of Schedule 10, including an assessment of the technical documentation as specified in paragraph 2 of that Schedule of at least one representative device per generic device group; or

(b)a conformity assessment based on type examination as specified in Schedule 11 coupled with a conformity assessment based on product conformity verification as specified in Schedule 12.

(4) For Class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors, the assessment of the technical documentation as specified in paragraph 2 of Schedule 10 must apply for every device.

(5) The Secretary of State may, by regulations, add to, or remove items from, the list of exempted Class IIb devices in paragraph (4), but the Secretary of State may only add to that list where the technology is well established and where the technology is similar to the devices listed.

(6) Class IIa devices, other than custom made or investigational devices, must be subject to—

(a)a conformity assessment as specified in Chapters I and III of Schedule 10, including an assessment of the technical documentation as specified in paragraph 2 of that Schedule of at least one representative device for each category of devices; or

(b)a conformity assessment specified in paragraph 8 or paragraph 12 of Schedule 12 along with the technical documentation (as set out in Schedules 4 and 5 for at least one representative device for each category of device.

(7) Subject to paragraph (8), Class I devices, other than custom-made or investigational devices, must be subject to a conformity assessment procedure which consists of the manufacturer issuing the declaration of conformity referred to in regulation 84 after drawing up the technical documentation set out in Schedules 4 and 5.

(8) If Class I devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments, the manufacturer must apply the procedures set out in—

(a)Chapters I and III of Schedule 10; or

(b)Part A of Schedule 12.

(9) Subject to paragraph (10), custom-made devices must be subject to the conformity assessment procedure set out in Schedule 13 and draw up the statement set out in paragraph 1(g) of that Schedule.

(10) Class III custom made implantable devices must, in addition to the procedure in paragraph (9), be subject to—

(a)the conformity assessment specified in Chapter I of Schedule 10; or

(b)the conformity assessment specified in Part A of Schedule 12.

(11) Devices which incorporate a medicinal product the action of which is ancillary to that of the device as set out in regulation 68(8), must, in addition to the procedures set out in paragraphs (2), (3), (6) or (7), also be subject to the procedure specified in Section 5.2 of Annex IX or, if applicable, Section 6 of Annex X to Regulation (EU) 2017/45.

(12) Devices which are manufactured utilising animal or human tissues and which fall within this Part in accordance with regulation 68(6)(g) and 68(6)(h), must, in addition to the procedures set out in paragraphs (2), (3), (6) or (7), also be subject to the procedure specified in Section 5.3 of Annex IX or that Section read with Section 6 of Annex X to Regulation (EU) 2017/745.

(13) Investigational devices must be subject to the requirements set out in regulations 103 to 119.

Involvement of notified bodies in conformity assessment procedures

99.(1) Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned.

(2) The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.

Exceptions to the conformity assessment procedures

100.(1) The requirements of regulation 98 do not apply where, on request, the Secretary of State has authorised the placing on the market, making available on the market or putting into service within the United Kingdom of a specific device and where that authorisation is granted for the purpose of protecting public health or patient safety or health.

(2) Except for the requirement to register in accordance with regulations 93 or 95, the requirements of this Part do not apply where the Secretary of State directs that a relevant device (or a class of relevant devices), which meets other requirements or standards (or which is marked other than with a CE marking) which the Secretary of State considers to be equivalent to the requirements and standards imposed by this Part, may be placed on the market.

(3) In paragraph (2), a standard or requirement is equivalent to a standard or requirement imposed by this Part if, in respect of the relevant device (or class of relevant devices), the standard or requirement provides for an equivalent level of safety and quality to that imposed by this Part.

Certificate of free sale

101.(1) For the purpose of export and upon request by a manufacturer, the Secretary of State must issue a certificate of free sale declaring that the manufacturer has its registered place of business in the United Kingdom and that the device in question, bearing the CE marking in accordance with this Part, may be marketed in the United Kingdom.

(2) The certificate of free sale must set out the Basic UDI-DI of the device as provided to the UDI database under regulation 92 and, where a notified body has issued a certificate, the certificate of free sale must set out the unique number identifying the certificate issued by the notified body.

Clinical evaluation and clinical investigations

Clinical evaluation

102.(1) Conformity with the relevant general safety and performance requirements set out in Schedule 3, the evaluation of undesirable side-effects and the acceptability of the benefit-risk-ratio referred to in paragraphs 1 and 8 of Schedule 3, must be based on clinical data which provides sufficient clinical evidence and, where applicable, the relevant data referred to in Schedule 5.

(2) The manufacturer must specify and justify the level of clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements and that level of clinical evidence must be appropriate in view of the characteristics of the device and its intended purpose.

(3) Manufacturers must plan, conduct and document a clinical evaluation in accordance with this Part and with Part A of Schedule 14.

(4) A clinical evaluation must be based on the following—

(a)a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where the following conditions are satisfied—

(i)it is demonstrated that the device subject to clinical evaluation for the intended purpose is equivalent to the device to which the data relate, in accordance with paragraph 3 of Schedule 14,

(ii)the data adequately demonstrate compliance with the relevant general safety and performance requirements;

(b)a critical evaluation of the results of all available clinical investigations, taking duly into consideration whether the investigations were performed under regulations 103 to 119 and Schedule 15;

(c)a consideration of currently available alternative treatment options for that purpose, if any.

(5) Subject to paragraphs (6), (8) and (9), clinical investigations must be performed for implantable devices and Class III devices.

(6) A clinical investigation need not be performed on an implantable device or a Class III device if the following conditions are met—

(a)the device has been designed by modifying a device already marketed by the same manufacturer;

(b)the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with paragraph 3 of Schedule 14 and this demonstration has been endorsed by the notified body;

(c)the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements.

(7) For the purposes of paragraph (6)(c), the Secretary of State may request the PMCF plan for the purposes of checking that the plan is appropriate and includes post market studies to demonstrate the safety and performance of the device.

(8) A clinical investigation need not be performed on an implantable device or a Class III device if, in addition to the conditions set out in paragraph (6), the following conditions are also met—

(a)the device (the second device) has been demonstrated by its manufacturer to be equivalent to a device (the first device) which has already been marketed by a manufacturer other than manufacturer of the second device;

(b)the two manufacturers have a contract in place which explicitly allows the manufacturer of the second device full access, on an ongoing basis, to the technical documentation of the relating to the first device;

(c)the clinical evaluation of the first device was performed in compliance with this Part or Regulation (EU) 2017/745 and the manufacturer of the second device provides clear evidence of that to the Secretary of State.

(9) A clinical investigation need not be performed on any of the following list of implantable devices or Class III devices provided the clinical evaluation is based on sufficient clinical data and the device is in compliance with a designated standard—

(a)devices which have been lawfully placed on the market or put into service in accordance with Parts II or III of these Regulations and for which the clinical evaluation—

(i)is based on sufficient clinical data, and

(ii)is in compliance with the relevant product-specific CS for clinical evaluation of that kind of device, where such CS is available; or

(b)devices that are—

(i)staples,

(ii)sutures,

(iii)dental fillings,

(iv)dental braces,

(v)tooth crowns,

(vi)screws,

(vii)wedges,

(viii)plates,

(ix)wires,

(x)pins,

(xi)clips, or

(xii)connectors.

(10) Where justified in view of well-established technologies, similar to those used in the devices listed in paragraph (9)(b), and where justified in order to protect the health and safety of individuals or to protect public health generally, the Secretary of State may by regulations amend the list in paragraph (9)(b) by adding or removing devices from the list.

(11) In the case of products without an intended medical purpose listed in Schedule 16—

(a)the requirement to demonstrate a clinical benefit in accordance with this Part must be understood as a requirement to demonstrate the performance of the device;

(b)clinical evaluations of these products must be based on relevant data concerning safety (including data from post-market surveillance, PMCF and where applicable specific clinical evaluation);

(c)clinical investigations must be performed for these products unless reliance on existing clinical data from an analogous medical device is duly justified.

(12) Without prejudice to paragraph (5), where the demonstration of conformity with general safety and performance requirements based on clinical data is not deemed appropriate, adequate justification for any such exception—

(a)must be given based on the results of the manufacturer’s risk management and on consideration of the specifics of the interaction between the device and the human body, the clinical performance intended and the claims of the manufacturer;

(b)the manufacturer must duly substantiate in the technical documentation referred to in Schedule 4 why it considers a demonstration of conformity with general safety and performance requirements that is based on the results of non-clinical testing methods alone, including performance evaluation, bench testing and pre-clinical evaluation, to be adequate.

(13) The clinical evaluation and its documentation must be updated throughout the life cycle of the device concerned with—

(a)clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Schedule 14 and the post-market surveillance plan referred to in regulation 122;

(b)for Class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in regulation 96 must be updated at least annually.

(14) The clinical evaluation, its results and the clinical evidence derived from it must be documented in a clinical evaluation report as referred to in paragraph 4 of Schedule 14, which, except for custom-made devices, must be part of the technical documentation referred to in Schedule 4 relating to the device concerned.

General requirements regarding clinical investigations conducted to demonstrate conformity of devices

103.(1) Where they are carried out as part of a clinical evaluation for the purposes of a conformity assessment with a view to placing a device on the market, clinical investigations must be designed, authorised, conducted, recorded and reported in accordance with the provisions of this regulation and in particular regulations 104 to 119 and Schedule 15, and carried out for one or more of the following purposes—

(a)to establish and verify that, under normal conditions of use, a device is designed, manufactured and packaged in such a way that falls within the definition of a medical device in regulation 69, and achieves the performance intended as specified by its manufacturer;

(b)to establish and verify the clinical benefits of a device as specified by its manufacturer;

(c)to establish and verify the clinical safety of the device and to determine any undesirable side-effects, under normal conditions of use of the device, and assess whether they constitute acceptable risks when weighed against the benefits to be achieved by the device.

(2) Where the sponsor of a clinical investigation is not established in the United Kingdom—

(a)that sponsor must ensure that a person is established in the United Kingdom as its legal representative;

(b)such legal representative must be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Part, and must be the addressee for all communications with the sponsor provided for in this Part;

(c)any communication with that legal representative must be deemed to be a communication with the sponsor.

(3) Clinical investigations must be designed and conducted in such a way that—

(a)the rights, safety, dignity and well-being of the subjects participating in a clinical investigation are protected and prevail over all other interests;

(b)the clinical data generated are scientifically valid, reliable and robust.

(4) Clinical investigations must be subject to a scientific and ethical review for which—

(a)the ethical review must be performed by an ethics committee;

(b)the Secretary of State must ensure that the procedures for review by ethics committees are compatible with the procedures set out in this Part for the assessment of the application for authorisation of a clinical investigation;

(c)at least one lay person must participate in the ethical review.

(5) A clinical investigation as referred to in paragraph (1) may be conducted only where all of the following conditions are met—

(a)the clinical investigation is the subject of an authorisation by the Secretary of State, in accordance with this Part;

(b)an ethics committee has not issued a negative opinion in relation to the clinical investigation;

(c)the sponsor, or its legal representative or a contact person pursuant to paragraph (2), is established in the United Kingdom;

(d)vulnerable populations and subjects are appropriately protected in accordance with regulations 105 to 108;

(e)the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;

(f)unless regulation 108 applies, the subject or, where the subject is not able to give informed consent, the subject’s legally designated representative has given informed consent in accordance with regulation 104;

(g)the subject or, where the subject is not able to give informed consent, the subject’s legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;

(h)the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning the subject in accordance with the Data Protection Act 2018 are safeguarded;

(i)the clinical investigation has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the clinical investigation plan and constantly monitored;

(j)the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, a qualified dental practitioner or any other authorised health professional entitled to provide the relevant patient care under clinical investigation conditions;

(k)no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on the subject’s legally designated representative, to participate in the clinical investigation;

(l)the investigational device in question—

(i)conforms to the applicable general safety and performance requirements set out in Schedule 3, apart from the aspects covered by the clinical investigation;

(ii)with regard to the aspects covered by the clinical investigation, every precaution has been taken to protect the health and safety of the subjects which includes, where appropriate, technical and biological safety testing and pre-clinical evaluation, as well as provisions in the field of occupational safety and accident prevention, taking into consideration the state of the art;

(m)the requirements of Schedule 15 are fulfilled;

(n)the sponsor, the sponsor’s legal representative and as appropriate the investigator must have sufficient insurance (or equivalent financial resources) in place to cover their liability arising from the clinical investigation.

(6) Any subject, or, where the subject is not able to give informed consent, the subject’s legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the clinical investigation at any time by revoking his or her informed consent.

(7) Subject to the provisions of the Data Protection Act 2018, the withdrawal of the informed consent in accordance with paragraph (6) must not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.

(8) The investigator must be an authorised health professional qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care and other personnel involved in conducting a clinical investigation must be authorised health professionals in the relevant medical field and in clinical research methodology,

(9) The facilities where the clinical investigation is to be conducted must be suitable for the clinical investigation and must be similar to the facilities where the device is intended to be used.

Informed consent

104.(1) Informed consent—

(a)must be written, dated and signed by the person performing the interview referred to in paragraph 104(2)(c), and by the subject or, where the subject is not able to give informed consent, the subject’s legally designated representative after having been duly informed in accordance with paragraph 104(2);

(b)may, where the subject is unable to write, be given and recorded through appropriate alternative means in the presence of at least one impartial witness and, in that case, the witness must sign and date the informed consent document;

(c)must be documented and a copy of that document or record be provided to the subject or to the subject’s legally designated representative;

(d)is only valid if adequate time is given for the subject, or the subject’s legally designated representative, to consider his or her decision to participate in the clinical investigation.

(2) Information given to the subject or, where the subject is not able to give informed consent, the subject’s legally designated representative, for the purposes of obtaining his or her informed consent must—

(a)enable the subject or the subject’s legally designated representative to understand—

(i)the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation;

(ii)the subject’s rights and guarantees regarding his or her protection, in particular the subject’s right to refuse to participate in and the right to withdraw from the clinical investigation at any time without any resulting detriment and without having to provide any justification;

(iii)the conditions under which the clinical investigation is to be conducted, including the expected duration of the subject’s participation in the clinical investigation;

(iv)the possible treatment alternatives, including the follow-up measures if the participation of the subject in the clinical investigation is discontinued;

(b)be kept comprehensive, concise, clear, relevant, and understandable to the subject or his or her legally designated representative;

(c)be provided in a prior interview with a member of the investigating team who is appropriately qualified;

(d)include information about the applicable damage compensation system referred to in regulation 109;

(e)include information about the availability of the clinical investigation results in accordance with paragraph (5).

(3) The information referred to in paragraph (2) must be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, the subject’s legally designated representative.

(4) In the interview referred to in paragraph (2)(c)—

(a)special attention must be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information; and

(b)the member of the investigating team must ensure that the subject has understood the information.

(5) The subject must be informed that a clinical investigation report and a summary presented in terms understandable to the intended user will be made available irrespective of the outcome of the clinical investigation, and must be informed, to the extent possible, when they have become available.

(6) A minor who is capable of forming an opinion and assessing the information given to him or her, must also assent in order to participate in a clinical investigation.

(7) Where appropriate, this regulation is to be read subject to regulation 108 (Clinical investigations in emergency situations).

Clinical investigations on incapacitated subjects

105.(1) In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a clinical investigation may be conducted only where, in addition to the conditions set out in regulation 103(5), all of the following conditions are met—

(a)unless regulation 108 applies, the informed consent of their legally designated representative has been obtained;

(b)unless regulation 108 applies, the incapacitated subjects have received the information referred to in regulation 104(2) in a way that is adequate in view of their capacity to understand it;

(c)the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in regulation 104(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;

(d)no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;

(e)the clinical investigation is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in clinical investigations on persons able to give informed consent, or by other research methods;

(f)the clinical investigation relates directly to a medical condition from which the subject suffers;

(g)there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the incapacitated subject outweighing the risks and burdens involved.

(2) The subject, as far as possible, should take part in the informed consent procedure.

Clinical investigations on minors

106.  A clinical investigation on minors may be conducted only where, in addition to the conditions set out in regulation 103(5), all of the following conditions are met—

(a)unless regulation 108 applies, the informed consent of their legally designated representative has been obtained;

(b)unless regulation 108 applies, the minors have received the information referred to in regulation 104(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;

(c)the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in regulation 104(2) to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator;

(d)no incentives or financial inducements are given to the subject or his or her legally designated representative except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation;

(e)the clinical investigation is intended to investigate treatments for a medical condition that only occurs in minors or the clinical investigation is essential with respect to minors to validate data obtained in clinical investigations on persons able to give informed consent or by other research methods;

(f)the clinical investigation either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;

(g)there are scientific grounds for expecting that participation in the clinical investigation will produce a direct benefit to the minor subject outweighing the risks and burdens involved;

(h)the minor must take part in the informed consent procedure in a way adapted to his or her age and mental maturity;

(i)if, during a clinical investigation, a person reaches the age of 16 years, that person’s express informed consent must be obtained before they can continue to participate in the clinical investigation.

Clinical investigations on pregnant or breastfeeding women

107.  A clinical investigation on a pregnant or breastfeeding woman may be conducted only where, in addition to the conditions set out in regulation 103(5), all of the following conditions are met—

(a)the clinical investigation has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;

(b)where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;

(c)no incentives or financial inducements are given to the subject except for compensation for expenses and loss of earnings directly related to the participation in the clinical investigation.

Clinical investigations in emergency situations

108.(1) Informed consent to participate in a clinical investigation may be obtained, and information on the clinical investigation may be given, after the decision to include the subject in the clinical investigation, provided that decision is taken at the time of the first intervention on the subject in accordance with the clinical investigation plan for that clinical investigation and that all of the following conditions are fulfilled—

(a)due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the clinical investigation;

(b)there are scientific grounds to expect that participation of the subject in the clinical investigation will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering or improving the health of the subject, or in the diagnosis of its condition;

(c)it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from the subject’s legally designated representative;

(d)the investigator certifies that they are not aware of any objections to participate in the clinical investigation previously expressed by the subject;

(e)the clinical investigation relates directly to the subject’s medical condition because of which it is not possible, within the therapeutic window, to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the clinical investigation is of such a nature that it may be conducted exclusively in emergency situations;

(f)the clinical investigation poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject’s condition.

(2) Where paragraph (1) applies, informed consent in accordance with regulation 104 must be sought to continue the participation of the subject in the clinical investigation, and information on the clinical investigation must be given, in accordance with the following requirements—

(a)for incapacitated subjects and minors, the informed consent must be sought by the investigator from his or her legally designated representative without undue delay and the information referred to in regulation 104(2) must be given as soon as possible to the subject and to the subject’s legally designated representative;

(b)for all other subjects, the informed consent must be sought by the investigator without undue delay from the subject or the subject’s legally designated representative, whichever can be done sooner, and the information referred to in regulation 104(2)must be given as soon as possible to the subject or his or her legally designated representative, as applicable.

(3) For the purposes of paragraph (2)(b), where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the clinical investigation must be obtained from the subject as soon as the subject is capable of giving informed consent.

(4) Where consent is not given, the subject or, where applicable, the subject’s legally designated representative must be informed of the right to object to the use of data obtained from the clinical investigation.

Damage compensation

109.  Sponsors must, taking account of the risk class of a device, the type of device and the size of the enterprise, hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability arising from damage caused by a clinical investigation.

Application for clinical investigations

110.(1) The sponsor of a clinical investigation must submit an application to the Secretary of State accompanied by the documentation referred to in Chapter II of Schedule 15.

(2) Within 10 days of receiving the application, the Secretary of State must notify the sponsor as to whether the clinical investigation falls within the scope of this Part and as to whether the application dossier is complete in accordance with Chapter II of Schedule 15.

(3) Within one week of any change occurring in relation to the documentation referred to in Chapter II of Schedule 15, the sponsor must—

(a)up-date the relevant data;

(b)make that change to the documentation clearly identifiable;

(c)notify the Secretary of State of the update.

(4) Where the Secretary of State finds that the clinical investigation applied for does not fall within the scope of this Part or that the application dossier is not complete, the Secretary of State must inform the sponsor and must set a time limit of maximum 10 days for the sponsor to comment, but the Secretary of State may extend this period by a maximum of 20 days where appropriate.

(5) Where—

(a)the sponsor has not provided comments within the time limit referred to in the paragraph (4), the application must be deemed to have lapsed;

(b)the sponsor considers the application does fall under the scope of this Part or is complete but the Secretary of State does not agree, the application must be considered to have been rejected.

(6) The Secretary of State must notify the sponsor within 5 days of receipt of the comments or of the requested additional information, whether the clinical investigation is considered as falling within the scope of this Part or that the application is complete.

(7) The Secretary of State may extend the notification periods referred to in paragraphs (2) and (6) each by a further 5 days.

(8) The validation date of the application is to be considered—

(a)the date on which the sponsor is notified in accordance with paragraphs (2) and (6); or

(b)where the sponsor is not notified, the last day of the periods referred to in paragraph (4).

(9) The sponsor may start a clinical investigation in the following circumstances—

(a)in the case of —

(i)investigational Class I devices or non-invasive Class IIa and Class IIb devices, immediately after the validation date of the application pursuant to paragraph (8); or

(ii)investigational devices, other than those referred to in paragraph (i) as soon as the Secretary of State has notified the sponsor of the Secretary of State’s authorisation; and

(b)in both cases, provided a negative opinion has not been issued by an ethics committee in the United Kingdom in respect of the clinical investigation.

(10) For the purposes of paragraph (9)(a)(ii), the Secretary of State must notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph (8) and the Secretary of State may extend this period by a further 20 days for the purpose of consulting with experts.

Assessment by Secretary of State

111.(1) The Secretary of State must ensure that the persons validating and assessing the clinical investigation application, or deciding on it do not have conflicts of interest and in particular are—

(a)independent of—

(i)the sponsor;

(ii)the investigators involved;

(iii)the person financing the clinical investigation; and

(b)free of any undue influence.

(2) The Secretary of State must ensure that the assessment is done jointly by an appropriate number of persons who collectively have the necessary qualifications and experience.

(3) The Secretary of State—

(a)must assess whether the clinical investigation is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected;

(b)must, while taking into account applicable designated standards, examine in particular—

(i)the demonstration of compliance of the investigational device with the applicable general safety and performance requirements, apart from the aspects covered by the clinical investigation, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects and this includes, where appropriate, assurance of technical and biological safety testing and pre-clinical evaluation;

(ii)whether the risk-minimisation solutions employed by the sponsor are described in designated standards and, in those cases where the sponsor does not use those standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by those designated standards;

(iii)whether the measures planned for the safe installation, putting into service and maintenance of the investigational device are adequate;

(iv)the reliability and robustness of the data generated in the clinical investigation, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;

(v)whether the requirements of Schedule 15 are met;

(vi)in the case of devices for sterile use, evidence of the validation of the manufacturer’s sterilisation procedures or information on the reconditioning and sterilisation procedures which have to be conducted by the investigation site;

(vii)the demonstration of the safety, quality and usefulness of any components of animal or human origin or of substances, which may be considered medicinal products in accordance with the Human Medicines Regulations 2012.

(4) The Secretary of State must refuse the authorisation of the clinical investigation if—

(a)the application dossier submitted remains incomplete;

(b)the device or the submitted documents, especially the investigation plan and the investigator’s brochure, do not correspond to the state of scientific knowledge, and the clinical investigation, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients;

(c)the requirements of regulation 103 (General requirements for clinical investigations conducted to demonstrate the conformity of devices) are not met; or

(d)any assessment under paragraph (3) is negative.

Appeal rights relating to regulations 110 and 111

112.(1) Where the sponsor is dissatisfied with a decision taken by the Secretary of State under regulation 110(6) or regulation 111(4), the sponsor or the sponsor’s legal representative in the United Kingdom may require the Secretary of State to seek advice from such person as the Institute determines as to—

(a)whether the clinical investigation falls within this Part; or

(b)whether the Secretary of State correctly refused the authorisation.

(2) Where the sponsor acts in accordance with paragraph (1), the sponsor is responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute.

(3) In this regulation, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.

Conduct of a clinical investigation

113.(1) The sponsor and the investigator must ensure that the clinical investigation is conducted in accordance with the approved clinical investigation plan.

(2) The sponsor—

(a)must ensure adequate monitoring of the conduct of the clinical investigation in order to—

(i)verify that the rights, safety and wellbeing of the subjects are protected;

(ii)that the reported data are reliable and robust;

(iii)that the conduct of the clinical investigation is in compliance with the requirements of this Part;

(b)must determine the extent and nature of the monitoring on the basis of an assessment taking into consideration all the characteristics of the clinical investigation including the following—

(i)the objective and methodology of the clinical investigation;

(ii)the degree of deviation of the intervention from normal clinical practice.

(3) All clinical investigation information must be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the Data Protection Act 2018.

(4) Appropriate technical and organisational measures must be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network.

(5) The Secretary of State must inspect, at an appropriate level, investigation sites to check that clinical investigations are conducted in accordance with the requirements of this Part and with the approved investigation plan.

(6) The sponsor must establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the investigation.

Clinical investigations regarding devices bearing a CE marking within the intended purpose of those devices

114.(1) Where—

(a)a clinical investigation is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with regulation 85, (‘PMCF investigation’); and

(b)the investigation would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome,

the sponsor must notify the Secretary of State at least 30 days prior to its commencement.

(2) The sponsor must include documentation referred to in Chapter II of Schedule 15 as part of the notification.

(3) The following provisions apply to PMCF investigations—

(a)sub-paragraphs (b) to (k) and (m) of regulation 103(5);

(b)regulations 116 to 118;

(c)regulation 119(6);

(d)the relevant provisions of Schedule 15.

Clinical investigations regarding devices bearing a CE marking outside the intended purpose of those devices

115.  Regulations 103 to 120 apply where a clinical investigation is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with regulation 85.

Substantial modifications to clinical investigations

116.(1) If a sponsor intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, the sponsor must—

(a)within one week of deciding to introduce modifications, notify the Secretary of State of the reasons for and the nature of those modifications;

(b)include an updated version of the relevant documentation referred to in Chapter II of Schedule 15 as part of the notification;

(c)ensure that changes to the relevant documentation are clearly identifiable.

(2) The Secretary of State must assess any substantial modification to the clinical investigation in accordance with the procedure laid down in regulation 111.

(3) The sponsor may implement the modifications referred to in paragraph (1) at the earliest 38 days after the notification referred to in that paragraph, unless—

(a)the Secretary of State has notified the sponsor of the Secretary of State’s refusal based on the grounds referred to in regulation 111(4) or on considerations of public health, subject and user safety or health, of public policy, or

(b)an ethics committee has issued a negative opinion in relation to the substantial modification to the clinical investigation.

(4) The Secretary of State may extend the period referred to in paragraph (3) by a further 7 days, for the purpose of consulting with experts.

Corrective measures to be taken by the Secretary of State

117.(1) Where the Secretary of State has grounds for considering that the requirements set out in this Part are not met, the Secretary of State may take any of the following measures—

(a)revoke the authorisation for the clinical investigation;

(b)suspend or terminate the clinical investigation;

(c)require the sponsor to modify any aspect of the clinical investigation.

(2) Before the Secretary of State takes any of the measures referred to in paragraph (1), the Secretary of State must, except where immediate action is required, ask the sponsor or the investigator or both for their opinion which must be delivered within 7 days.

Information from the sponsor at the end of a clinical investigation or in the event of a temporary halt or early termination

118.(1) Subject to paragraph (2), if the sponsor has temporarily halted a clinical investigation or has terminated a clinical investigation early, the sponsor must inform the Secretary of State within 15 days of the temporary halt or early termination, providing a justification for that halt or termination.

(2) Where the sponsor has temporarily halted the clinical investigation or terminated early it early on safety grounds, the sponsor must inform the Secretary of State of that halt or termination within 24 hours.

(3) The end of a clinical investigation is deemed to coincide with the last visit of the last subject unless another point in time for such end is set out in the clinical investigation plan.

(4) The sponsor must notify the Secretary of State of the end of a clinical investigation and that notification must be made within 15 days of the end of the clinical investigation.

(5) Irrespective of the outcome of the clinical investigation but subject to paragraph (7), within one year of the end of the clinical investigation or within 3 months of the early termination or temporary halt, the sponsor must submit to the Secretary of State a clinical investigation report as referred to in paragraph 2(8) of Chapter I and paragraph 7 of Chapter III of Schedule 15.

(6) The clinical investigation report must—

(a)be accompanied by a summary presented in terms that are easily understandable to the intended user;

(b)be submitted by the sponsor to the Secretary of State along with that summary.

(7) Where, for scientific reasons, it is not possible to submit the clinical investigation report within one year of the end of the investigation, it must—

(a)be submitted as soon as it is available;

(b)specify in the clinical investigation plan, referred to in paragraph 3 of Chapter II of Schedule 15, when the results of the clinical investigation are going to be available, together with a justification for why the report cannot be submitted within one year of the end of the investigation.

(8) The Secretary of State–

(a)may issue guidelines regarding the content and structure of the summary of the clinical investigation report;

(b)may issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis (and may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of clinical investigations).

(9) The summary and the clinical investigation report referred to in paragraph (6) must—

(a)in circumstances other than those provided for in sub-paragraphs (b) and (c), be made publicly accessible, at the latest when the device is registered in accordance with regulation 93 and before it is placed on the market;

(b)in cases of early termination or temporary halt, become publicly accessible immediately after submission; or

(c)if the device is not registered in accordance with regulation 93, become publicly accessible within one year of the summary and the report having been submitted pursuant to paragraph (5).

Recording and reporting of adverse events that occur during clinical investigations

119.(1) The sponsor must fully record all of the following—

(a)any adverse event of a type identified in the clinical investigation plan as being critical to the evaluation of the results of that clinical investigation;

(b)any serious adverse event;

(c)any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(d)any new findings in relation to any event referred to in sub-paragraphs (a) to (c);

(2) The sponsor must report, without delay (but having regard to paragraph (3)), to the Secretary of State, all of the following—

(a)any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;

(b)any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(c)any new findings in relation to any event referred to in sub-paragraphs (a) and (b).

(3) The period for reporting must take account of the severity of the event and, where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.

(4) Upon request by the Secretary of State, the sponsor must provide all information referred to in paragraph (1).

(5) The sponsor must also report to the Secretary of State any event referred to in paragraph (2) that occurred in a country outside the United Kingdom in which a clinical investigation is performed under the same clinical investigation plan as the one applying to a clinical investigation covered by this Part.

(6) This regulation does not apply to PMCF investigations referred to in regulation 114 but the provisions on vigilance provided for in regulations 125 to 128 apply instead of this regulation.

Requirements regarding other clinical investigations

120.(1) Clinical investigations, not performed pursuant to any of the purposes listed in regulation 103(1), must comply with the provisions of regulation 103(2) to 103(3), sub-paragraphs (b), (c), (d), (f), (h), and (l) of regulation 103(5) and regulation 103(8).

(2) In order to protect the rights, safety, dignity and well-being of subjects and the scientific and ethical integrity of clinical investigations not performed for any of the purposes listed in regulation 103(1), Secretary of State may by regulations define any additional requirements for such investigations.

POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

Post-market surveillance
Post-market surveillance system of the manufacturer

121.(1) For each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device and that system must be an integral part of the manufacturer’s quality management system referred to in regulation 76(14).

(2) The post-market surveillance system must be suited to—

(a)actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime;

(b)drawing the necessary conclusions;

(c)determining, implementing and monitoring any preventive and corrective actions.

(3) The manufacturer must ensure that—

(a)data gathered by the manufacturer’s post-market surveillance system is used in particular—

(i)to update the benefit-risk determination and to improve the risk management as referred to in Part 1 of Schedule 3;

(ii)to update the design and manufacturing information, the instructions for use and the labelling;

(iii)to update the clinical evaluation;

(iv)to update the summary of safety and clinical performance referred to in regulation 96;

(v)for the identification of needs for preventive, corrective or field safety corrective action;

(vi)for the identification of options to improve the usability, performance and safety of the device;

(vii)when relevant, to contribute to the post-market surveillance of other devices;

(viii)to detect and report trends in accordance with regulation 126;

(b)the technical documentation is updated accordingly.

(4) If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer must—

(a)implement the appropriate measures and inform the Secretary of State and, where applicable, the notified body;

(b)where a serious incident is identified or a field safety corrective action is implemented, report that incident in accordance with regulation 125.

Post-market surveillance plan

122.  The post-market surveillance system referred to in regulation 121 must be based on a post-market surveillance plan, the requirements for which are set out in paragraph 1(2) of Schedule 5 and, for devices other than custom-made devices, the post-market surveillance plan must be part of the technical documentation specified in Schedule 4.

Post-market surveillance report

123.(1) Manufacturers of Class I devices must prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in regulation 122 together with a rationale and description of any preventive and corrective actions taken.

(2) The report must be updated when necessary and made available to the Secretary of State upon request.

Periodic safety update report

124.(1) Manufacturers of Class IIa, Class IIb and Class III devices must prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in regulation 122 together with a rationale and description of any preventive and corrective actions taken.

(2) Throughout the lifetime of the device concerned, that PSUR must set out—

(a)the conclusions of the benefit-risk determination;

(b)the main findings of the PMCF;

(c)the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

(3) Manufacturers of Class IIb and Class III devices must—

(a)update the PSUR at least annually;

(b)ensure that, except in the case of custom-made devices, the is part of the technical documentation as specified in Schedules 4 and 5.

(4) Manufacturers of Class IIa devices must—

(a)update the PSUR when necessary and at least every 2 years;

(b)ensure that, except in the case of custom-made devices, the PSUR is part of the technical documentation as specified in Schedules 4 and 5.

(5) For custom-made devices, the PSUR must be part of the documentation referred to in paragraph 12(2) of Schedule 13.

(6) For Class III or implantable devices a manufacturer must—

(a)submit the PSUR to the notified body involved in the conformity assessment;

(b)make available to the Secretary of State the evaluation of the PSUR made by the notified body.

(7) For devices other than Class III devices a manufacturer must—

(a)make the PSUR available to the notified body involved in the conformity assessment;

(b)upon request by the Secretary of State, make the PSUR available to the Secretary of State.

Reporting of serious incidents and field safety corrective actions

125.(1) Manufacturers of devices made available on the market, other than investigational devices, must report, to the Secretary of State the following—

(a)any serious incident involving devices made available on the market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to regulation 126;

(b)any field safety corrective action in respect of devices made available on the market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the market, if the reason for the field safety corrective action is not limited to the device made available in the third country.

(2) The period for the reporting referred to in paragraph (1) must take account of the severity of the serious incident.

(3) Subject to paragraphs (4) and (5), manufacturers must report any serious incident as referred to in paragraph (1)(a) immediately after they have established the causal relationship between that incident and their device, or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.

(4) In the event of a serious public health threat, the report referred to in paragraph (1) must be provided not later than 2 days after the manufacturer becomes aware of the threat.

(5) In the event of death or an unanticipated serious deterioration in a person’s state of health, the report must be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.

(6) Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.

(7) If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it must nevertheless submit a report within the timeframe required in accordance with paragraphs (2) to (5).

(8) Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer must, without undue delay, report the field safety corrective action referred to in paragraph (1)(b) in advance of the field safety corrective action being undertaken.

(9) For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the Secretary of State, has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.

(10) The Secretary of State must—

(a)take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the Secretary of State suspected serious incidents referred to in paragraph (1)(a);

(b)record reports received from healthcare professionals, users and patients.

(11) Where the Secretary of State obtains such reports on suspected serious incidents referred to in paragraph (1)(a) from healthcare professionals, users or patients, the Secretary of State must take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.

(12) Where the manufacturer of the device concerned considers that an incident is a serious incident, it must provide a report in accordance with paragraphs (1) to (5) on that serious incident to the Secretary of State and must take the appropriate follow-up action in accordance with regulation 127.

(13) Where—

(a)the manufacturer of the device considers that an incident is not a serious incident or is an expected undesirable side-effect which will be covered by trend reporting in accordance with regulation 126, the manufacturer must provide an explanatory statement;

(b)the Secretary of State does not agree with the conclusion of the explanatory statement, the Secretary of State may require the manufacturer—

(i)to provide a report in accordance with paragraphs (1) to (5);

(ii)to ensure that appropriate follow-up action is taken in accordance with regulation 127.

Trend reporting

126.(1) Manufacturers must report to the Secretary of State any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side-effects that could have a significant impact on the benefit-risk analysis referred to in paragraphs (1) and (5) of Schedule 3 and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits.

(2) The significant increase must be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices in question, during a specific period as specified in the technical documentation and product information.

(3) The manufacturer must specify how to manage the incidents referred to in paragraph (1) and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in regulation 122.

(4) The Secretary of State may conduct assessments on the trend reports referred to in paragraph (1) and require the manufacturer to adopt appropriate measures in accordance with this Part in order to ensure the protection of public health and patient safety.

Analysis of serious incidents and field safety corrective actions

127.(1) Following the reporting of a serious incident pursuant to regulation 125(1), a manufacturer must—

(a)without delay, perform the necessary investigations in relation to the serious incident and the devices concerned;

(b)include a risk assessment of the incident and field safety corrective action taking into account criteria as referred to in paragraph (4)(a) as appropriate.

(2) A manufacturer must—

(a)cooperate with the Secretary of State during the investigations referred to in paragraph (1);

(b)not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the Secretary of State of such action.

(3) The Secretary of State must take the necessary steps to ensure that any information regarding a serious incident that has occurred, or a field safety corrective action that has been or is to be undertaken, and that is brought to the Secretary of State’s knowledge in accordance with regulation 125, is evaluated, if possible together with the manufacturer and, where relevant the notified body concerned.

(4) For the purposes of the evaluation referred to in paragraph (3), the Secretary of State must evaluate—

(a)the risks arising from the reported serious incident and evaluate any related field safety corrective actions, taking into account the protection of public health and criteria such as—

(i)causality, detectability and probability of recurrence of the problem;

(ii)frequency of use of the device;

(iii)probability of occurrence of direct or indirect harm;

(iv)the severity of that harm;

(v)the clinical benefit of the device;

(vi)the intended and potential users;

(vii)the population affected;

(b)the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the principle of inherent safety contained in Schedule 3.

(5) Upon request by the Secretary of State, manufacturers must provide all documents necessary for the risk assessment.

(6) The Secretary of State must monitor the manufacturer’s investigation of a serious incident and where necessary, the Secretary of State may intervene in a manufacturer’s investigation or initiate an independent investigation.

(7) A manufacturer must provide a final report to the Secretary of State setting out its findings from the investigation which must set out conclusions and where relevant indicate corrective actions to be taken.

(8) In the case of devices referred to in regulation 68(8) and where the serious incident or field safety corrective action may be related to a substance which, if used separately, would be considered to be a medicinal product, the Secretary of State must ensure that those responsible for licensing medicinal products are informed of that serious incident or field safety corrective action.

(9) In the case of —

(a)devices referred to in regulation 68(6)(h);

(b)devices falling under regulation 68(14),

and where the serious incident or field safety corrective action may be related to the derivatives of tissues or cells of human origin utilised for the manufacture of the device, the Secretary of State must inform the Human Tissue Authority.

(10) A manufacturer must ensure that information about the field safety corrective action taken—

(a)is brought without delay to the attention of users of the device in question by means of a field safety notice;

(b)except in cases of urgency, the content of the draft field safety notice must be submitted to the Secretary of State to allow the Secretary of State to make comments.

(11) The field safety notice must—

(a)allow the correct identification of the device or devices involved;

(b)explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons;

(c)clearly indicate all the actions to be taken by users;

(d)be accessible to the public.

Analysis of vigilance data

128.(1) The Secretary of State must put in place systems and processes to actively monitor the data available, in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.

(2) Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the Secretary of State must inform the manufacturer, or where applicable the UK responsible person, which must then take the necessary corrective actions.

Electronic system on vigilance and on post market surveillance

129.(1) The Secretary of State must set up and manage an electronic system to collate and process the following information—

(a)the reports by manufacturers on serious incidents and field safety corrective actions;

(b)the periodic summary reports by manufacturers;

(c)the reports by manufacturers on trends;

(d)the PSURs;

(e)the field safety notices by manufacturers.

(2) The Secretary of State must ensure that healthcare professionals and the public receive appropriate information contained in the electronic system referred to in paragraph (1).

(3) The Secretary of State—

(a)may make arrangements with other countries or international organisations for the purpose of granting access (at an appropriate level) to the electronic system referred to in paragraph (1);

(b)must only make any such arrangements on the basis of reciprocity;

(c)must base any such arrangements on data protection rules equivalent to those applicable in the United Kingdom.

Market surveillance

Market surveillance activities

130.(1) The Secretary of State must—

(a)perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples;

(b)take account of established principles regarding risk assessment and risk management, vigilance data and complaints.

(2) The Secretary of State must—

(a)draw up an annual surveillance activity plan;

(b)allocate a sufficient number of material and competent human resources in order to carry out those activities.

(3) In order to fulfil the obligations laid down in paragraph (1), the Secretary of State—

(a)may require economic operators to make available the documentation and information necessary for the purpose of carrying out those activities and, where justified, to provide the necessary samples of devices or access to devices free of charge;

(b)must carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, suppliers or subcontractors, and, where necessary, at the facilities of professional users.

(4) The Secretary of State must prepare and publish an annual summary of the results of surveillance activity.

(5) The Secretary of State may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or are falsified devices where the Secretary of State deems it necessary to do so in the interests of the protection of public health.

(6) Following each inspection carried out for the purposes referred to in paragraph (1), the Secretary of State must—

(a)draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Part;

(b)set out in the report any corrective actions needed.

(7) The Secretary of State must—

(a)communicate the content of the report referred to in paragraph (6) to the economic operator that has been the subject of the inspection;

(b)before adopting the final report, give that economic operator the opportunity to submit comments.

(8) The Secretary of State must—

(a)at least every 4 years, review and assess the functioning of market surveillance activities;

(b)make a summary of the results accessible to the public.

(9) Where appropriate, the Secretary of State must cooperate with the authorities of third countries with a view to exchanging information, providing technical support and promoting activities relating to market surveillance.

Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

131.  Where the Secretary of State, based on data obtained by vigilance or market surveillance activities or on other information, has reason to believe that a device—

(a)may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or

(b)otherwise does not comply with the requirements laid down in this Part,

the Secretary of State must carry out an evaluation covering all requirements laid down in this Part relating to the risk presented by the device, or to any other non-compliance of the device and the relevant economic operators must cooperate with the Secretary of State.

Procedure for dealing with devices presenting an unacceptable risk to health and safety

132.(1) Where, having performed an evaluation pursuant to regulation 131, the Secretary of State finds that the device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the Secretary of State must—

(a)without delay, require a manufacturer of the devices, and all other relevant economic operators established in the United Kingdom, to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Part relating to the risk presented by the device;

(b)in a manner that is proportionate to the nature of the risk, restrict the making available of the device on the market, subject the making available of the device for specific requirements, withdraw the device from the market, or recall it, within a reasonable period that is clearly defined and communicated to the relevant economic operator.

(2) The economic operators as referred to in paragraph (1) must, without delay, ensure that all appropriate corrective action is taken throughout the United Kingdom in respect of all the devices concerned that they have made available on the market.

(3) Where the economic operator as referred to in paragraph (1) does not take adequate corrective action within the period referred to in paragraph (1), the Secretary of State must take all appropriate measures to prohibit or restrict the making available of the device on the market, to withdraw the device or to recall it.

Other non-compliance

133.(1) Where, having performed an evaluation pursuant to regulation 131, the Secretary of State finds that a device does not comply with the requirements laid down in this Part but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the Secretary of State must require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non- compliance.

(2) Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph (1), the Secretary of State must, without delay, take all appropriate measures to restrict or prohibit the product being made available on the market or to ensure that it is recalled or withdrawn from the market.

Preventive health protection measures

134.  Where the Secretary of State, after having performed an evaluation which indicates a potential risk related to a device or a specific category or group of devices, considers that, in order to protect the health and safety of patients, users or other persons or other aspects of public health, the making available on the market or putting into service of a device or a specific category or group of devices should be prohibited, restricted or made subject to particular requirements or that such device or category or group of devices should be withdrawn from the market or recalled, the Secretary of State may take any necessary and justified measures in accordance with Part VII of these Regulations or under relevant consumer protection legislation.

Regulations

135.(1) Regulations under this Part may—

(a)make different provision for different purposes or different areas;

(b)make consequential, incidental, transitional or supplemental provision.

(2) A power to make regulations under this Part is exercisable by the Secretary of State by statutory instrument.

(3) A statutory instrument which contains regulations under this Part is subject to annulment in pursuance of a resolution of each House of Parliament..

PART 3New part IX of the Medical Devices Regulations

11.  After regulation 135 (as inserted by regulation 10) insert—

PART IXThe rights, powers, liabilities, obligations, restrictions, remedies and procedures recognised under the in vitro diagnostic Medical Devices Regulation (see regulation 4P)

Scope and definitions

Subject matter and scope

136.(1) This Part lays down the rules for and applies to the placing on the market, the making available on the market and the putting into service of—

(a)in vitro diagnostic medical devices for human use; and

(b)accessories to such medical devices.

(2) This Part also applies to performance studies concerning in vitro diagnostic medical devices and accessories to such devices.

(3) For the purposes of this Part and Schedules 17 to 28 in vitro diagnostic medical devices and accessories to in vitro diagnostic medical devices are referred to as ‘devices’.

(4) This Part does not apply to—

(a)relevant devices placed on the market in accordance with Part IV;

(b)products for general laboratory use or research-use only products, unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination;

(c)invasive sampling products or products which are directly applied to the human body for the purpose of obtaining a specimen;

(d)internationally certified reference materials;

(e)materials used for external quality assessment schemes.

(5) Any device which, when placed on the market or put into service, incorporates, as an integral part, a medical device as defined in regulation 69 is governed by Part VIII, but the requirements of this Part apply to the in vitro diagnostic medical device part.

(6) Where a device is also machinery within the meaning of the Supply of Machinery (Safety) Regulations 2008(66) and where—

(a)a hazard under that legislation exists;

(b)the provisions of that legislation are more specific than the general safety and performance requirements set out in Schedule 17,

the device must meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008.

(7) This Part does not affect the application of the Ionising Radiation (Basic Safety Standards) (Miscellaneous Provisions) Regulations 2018 or any of the other measures which immediately before exit day transposed Directive 2013/59/Euratom and which are retained EU law .

(8) This Part does not affect the power of the Secretary of State to restrict the use of any specific type of device in relation to aspects not covered by this Part.

(9) This Part does not affect the organisation, delivery or financing of health services and medical care, including—

(a)the rules relating to the supply of devices on a medical prescription;

(b)requirements relating to—

(i)the dispensing of devices by certain health professionals or health care institutions; use certain devices;

(ii)the use of certain devices being accompanied by specific professional counselling.

(10) This Part does not restrict the freedom of the press or freedom of expression.

Definitions

137.  In this Part and Schedules 17 to 28—

“accessory for an in vitro diagnostic medical device” means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical devices to specifically enable the in vitro diagnostic medical devices to be used in accordance with its intended purpose or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device in terms of its intended purpose;

“adverse event” means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study;

“analytical performance” means the ability of a device to correctly detect or measure a particular analyte;

“authorised representative” means any person established outside the United Kingdom but within the European Economic Area, who has received and accepted a written mandate from a manufacturer, located outside the European Economic Area, to act on the manufacturer’s behalf in carrying out certain obligations under Regulation (EU) 2017/746;

“benefit risk determination” means the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer;

“calibrator” means a measurement reference material used in the calibration of a device;

“CE marking of conformity” or “CE marking” means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Part and other applicable legislation providing for its affixing;

“clinical benefit” means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;

“clinical evidence” means clinical data and performance evaluation results, pertaining to a device of a sufficient number and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefits, when used as intended by the manufacturer;

“clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;

“common specifications” or “CS” must be construed in accordance with regulation 144;

“companion diagnostic” means device which is essential for the safe and effective use of a corresponding medicinal product to—

(a)

identify, before or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or

(b)

identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;

“compatibility” is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose to do any or all of the following—

(a)

perform without losing or compromising the ability to perform as intended;

(b)

integrate or operate without the need for modification or adaption of any part of the combined devices;

(c)

be used together without conflict, interference or adverse reaction;

“conformity assessment” means the process demonstrating whether the requirements of this Part relating to a device have been fulfilled;

“conformity assessment body” means a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection;

“control material” means a substance, material or article intended by its manufacturer to be used to verify the performance characteristics of a device;

“corrective action” means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation;

“designated standard” has the same meaning as in regulation 3A;

“device deficiency” in relation to a device for performance study, means any inadequacy in its identity, quality, durability, reliability, safety or performance including malfunction, use errors or inadequacy in information supplied by the manufacturer;

“device for near-patient testing” means any device that is not intended for self-testing but is intended to perform testing outside the laboratory environment, generally near to, or at the side of, the patient by a health professional;

“device for performance study” means a device intended by the manufacturer to be used in a performance study but does not include a device intended to be used for research purposes with no medical objective;

“device for self-testing” means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;

“diagnostic sensitivity” means the ability of a device to identify the presence of a target marker associated with a particular disease or condition;

“diagnostic specificity” means the ability of a device to recognise the absence of a target marker associated with a particular disease or condition;

“distributor” means any person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;

“economic operator” means a manufacturer, an authorised representative, a UK responsible person, an importer or a distributor;

“ethics committee” means an independent body established or recognised under the Care Act 2014;

“falsified device” means any device with a false presentation of its identity, of its source or its CE marking certificates or documents relating to CE marking procedures, but a device is not a falsified device where any non-compliance is unintentional;

“field safety corrective action” means corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market;

“field safety notice” means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action;

“fully refurbishing” for the purposes of the definition of manufacturer, means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Part, combined with the assignment of a new lifetime to the refurbished device;

“generic device group” means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics;

“health institution” means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health;

“importer” means any person established within the United Kingdom that places a device on the market from a country outside the United Kingdom;

“incident” in relation to a device made available on the market, means—

(a)

any malfunction or deterioration in its characteristics or performance, including use-error due to its ergonomic features and any inadequacy in the information supplied by the manufacturer;

(b)

any harm as a consequence of a medical decision; or

(c)

action taken or not taken on the basis of information or results provided by the device;

“informed consent” means a subject’s free and voluntary expression of his or her willingness to participate in a particular performance study, after having been informed of all aspects of the performance study that are relevant to the subject’s decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the performance study;

“instructions for use” means the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken;

“intended purpose” means the use for which a device is intended as set out in—

(a)

the data supplied by the manufacturer on the label;

(b)

the instructions for use; or

(c)

the promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation;

“interoperability” is the ability of 2 or more devices, including software, from the same manufacturer or from different manufacturers to do any or all of the following—

(a)

exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data;

(b)

communicate with each other;

(c)

work together as intended;

“interventional clinical performance study” means a clinical performance study where the test results may influence patient management decisions or may be used to guide treatment;

“investigator” means an individual responsible for the conduct of a performance study at a performance study site;

“in vitro diagnostic medical device” means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following—

(a)

concerning a physiological or pathological process or state;

(b)

concerning congenital physical or mental impairments;

(c)

concerning the predisposition to a medical condition or a disease;

(d)

to determine the safety and compatibility with potential recipients;

(e)

to predict treatment response or reactions;

(f)

to define or monitor therapeutic measures; and

specimen receptacles must also be deemed to be in vitro diagnostic medical devices;

“kit” means a set of components that are packaged together and intended to be used to perform a specific in vitro diagnostic examination;

“label” means the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices;

“lay person” means an individual who does not have formal education in a relevant field of healthcare or medical discipline;

“legally designated representative”, has the meaning given to the term “legal representative” in Part 1 of Schedule 1 to the Medicines for Human Use (Clinical Trials) Regulations 2004;

“likelihood ratio” means the likelihood of a given result arising in an individual with the target clinical condition or physiological state compared to the likelihood of the same result arising in an individual without that clinical condition or physiological state;

“making available on the market” means any supply of a device, other than a device for performance study, for distribution, consumption or use on the United Kingdom market in the course of a commercial activity, whether in return for payment or free of charge;

“manufacturer” means a person who manufacturers or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;

“market surveillance” means the activities carried out and measures taken by public authorities to check and ensure that devices comply with the requirements set out in the relevant legislation and do not endanger health, safety or any other aspect of public interest protection;

“medical device” has the same meaning as in regulation 69;

“negative predictive value” means the ability of a device to separate true negative results from false negative results for a given attribute in a given population;

“notified body” means a conformity assessment body designated in accordance with Regulation (EU) 2017/746;

“performance of a device” means the ability of a device to achieve its intended purpose as claimed by the manufacturer and consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;

“performance evaluation” means an assessment and analysis of data to establish or verify the scientific validity, the analytical and, where applicable, the clinical performance of a device;

“performance study” means a study undertaken to establish or confirm the analytical or clinical performance of a device;

“performance study plan” means a document that describes the rationale, objectives, design methodology, monitoring, statistical considerations, organisation and conduct of a performance study;

“placing on the market” means the first making available of a device, other than a device for performance study, on the United Kingdom market;

“positive predictive value” means the ability of a device to separate true positive results from false positive results for a given attribute in a given population;

“post-market surveillance” means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions;

“post-market performance follow-up” (PMPF) means a continuous process of updating the performance evaluation;

“predictive value” means the probability that a person with a positive device test result has a given condition under investigation, or that a person with a negative device test result does not have a given condition;

“putting into service” means the making available of a device, other than a device for performance study, to the final user as being ready for use on the United Kingdom market for the first time for its intended purpose;

“recall” means any measure aimed at achieving the return of a device that has already been made available to the end user;

“Regulation (EU) 2017/746” means Regulation (EU) 2017/746 of the European Parliament and of the Council of 5th April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU(67) as it has effect in European Union Law;

“risk” means the combination of the probability of occurrence of harm and the severity of that harm;

“scientific validity of an analyte” means the association of an analyte with a clinical condition or a physiological state;

“serious adverse event” means any adverse event that led to any of the following—

(a)

a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual’s offspring;

(b)

death;

(c)

serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following—

(i)

life-threatening illness or injury;

(ii)

permanent impairment of a body structure or a body function;

(iii)

hospitalisation or prolongation of patient hospitalisation;

(iv)

medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function;

(v)

chronic disease;

(d)

foetal distress, foetal death or a congenital physical or mental impairment or birth defect;

“serious incident” means any incident that directly or indirectly led, might have led or might lead to any of the following—

(a)

the death of a patient, user or other person;

(b)

the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health;

(c)

serious public health threat;

“serious public health threat” means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time;

“single-use device” means a device that is intended to be used during a single procedure;

“specimen receptacle” means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination;

“sponsor” means any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the performance study;

“subject” means an individual who participates in a performance study and whose specimens undergo in vitro examination by a device for performance study or by a device used for control purposes;

“UK responsible person” has the same meaning as in regulation 2;

“Unique Device Identifier” (“UDI”) means a series of numeric or alphanumeric characters that is created through internationally recognised and accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market;

“UDI system”, “UDI database” and related expressions have the meaning given in, or are to be construed in accordance with, in Part C of Schedule 22;

“user” means any healthcare professional or lay person who uses a device;

“withdrawal” means any measure aimed at preventing a device in the supply chain from being further made available on the market.

Regulatory status of products

138.(1) Subject to paragraph (2), the Secretary of State may by regulations determine whether or not a specific product, category or group of products, falls within the definition of an in vitro diagnostic medical device or an accessory to an in vitro diagnostic medical device.

(2) Before making regulations under paragraph (1), the Secretary of State must consult such persons, agencies, or bodies as the Secretary of State considers appropriate to consult.

Genetic information, counselling and informed consent

139.  The Secretary of State must ensure that where a genetic test is used on individuals, in the context of healthcare and for the medical purposes of diagnostics, improvement of treatment, predictive or prenatal testing—

(a)the individual being tested or, where applicable, his or her legally designated representative is provided with relevant information on the nature, the significance and the implications of the genetic test, as appropriate;

(b)subject to paragraph (2), there is appropriate access to counselling in the case of the use of genetic tests that provide information on the genetic predisposition for medical conditions or diseases which are generally considered to be untreatable according to the state of science and technology.

(2) Paragraph (1)(b) does not apply in cases where a diagnosis of a medical condition or a disease which the individual being tested is already known to have is confirmed by a genetic test or in cases where a companion diagnostic is used.

Making available on the market and putting into service of devices, obligations of economic operators, CE marking

Placing on the market and putting into service

140.(1) A device to which this Part applies may be placed on the market or put into service only if it complies with this Part when duly supplied and properly installed, maintained and used in accordance with its intended purpose.

(2) A device to which this Part applies must meet the general safety and performance requirements set out in Schedule 17 which apply to it, taking into account its intended purpose.

(3) Demonstration of conformity with the general safety and performance requirements must include a performance evaluation in accordance with regulation 167.

(4) Devices that are manufactured and used within health institutions, with the exception of devices for performance studies, must be considered as having been put into service.

(5) With the exception of the relevant general safety and performance requirements set out in Schedule 17, the requirements of this Part do not apply to a device which is manufactured and used only within a health institution, provided that all of the following conditions are met—

(a)the device is not transferred to another legal entity;

(b)manufacture and use of the devices occur under appropriate quality management systems;

(c)the laboratory of the health institution is compliant with standard EN ISO 15189 and, where applicable, provisions regarding accreditation;

(d)the health institution justifies in its documentation that the specific needs of the target patient group cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market;

(e)on request from the Secretary of State, the health institution provides the Secretary of State with information (which must include justification for its manufacturing, modification and use of such devices) on the use of the device to the Secretary of State;

(f)the health institution draws up a declaration which it must make publicly available, including—

(i)the name and address of the manufacturing health institution;

(ii)the details necessary to identify the devices;

(iii)a declaration that the device meets the general safety and performance requirements set out in Schedule 17 and, where applicable, information on which requirements are not fully met and a reasoned justification for not meeting those requirements;

(g)for Class D devices (and for other classes of device in accordance with the rules set out in Schedule 23) the health institution draws up a document which makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices and the intended purpose, and which is sufficiently detailed to enable the Secretary of State to ascertain that the general safety and performance requirements set out in Schedule 17 are met;

(h)the Secretary of State may apply the provisions of sub-paragraph (g) also to Class A, B or C devices in accordance with the rules set out in Schedule 23;

(i)the health institution must take all necessary measures to ensure that all devices are manufactured in accordance with the document referred to in sub-paragraph (g);

(j)the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.

(6) The Secretary of State may require a health institution which has complied with paragraph (5) to submit to the Secretary of State any further relevant information about such devices which it has manufactured and used.

(7) The Secretary of State may restrict the manufacture and use of a specified type of device manufactured in accordance with paragraph (5) and, for the purposes of considering such a restriction, must be permitted access to inspect the activities of the health institutions.

(8) Paragraph (5) does not apply to the devices that are manufactured on an industrial scale.

Distance sales

141.(1) A device offered by means of information society services to a person established in the United Kingdom must comply with this Part.

(2) A device which is—

(a)not placed on the market;

(b)used for the provision of a diagnostic or therapeutic service used in the context of a commercial activity, whether in return for payment or free of charge; and

(c)offered by means of information society services or by other means of communication (whether directly or through intermediaries) to a person in the United Kingdom,

must comply with this Part.

(3) The Secretary of State may require a person offering a device, as described in paragraph (1) or providing a service described in paragraph (2) relating to the device.

(4) In this regulation “information society service” means a “service” within the meaning of Article 1(1)(b) of Directive 2015/1535/EU of the European Parliament and of the Council of 9th September 2015 (as it has effect in European Union Law).

Claims

142.  In the labelling, instructions for use, making available, putting into service and advertising of devices, a person must not use text, names, trademarks, pictures and figurative or other signs which may mislead the user or the patient with regard to the device’s intended purpose, safety and performance by—

(a)ascribing functions and properties to the device which the device does not have;

(b)creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;

(c)failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose; or

(d)suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.

Use of standards

143.(1) Devices that are in conformity with the designated standards, or the relevant parts of those standards, are presumed to be in conformity with the requirements of this Part which cover those designated standards or relevant parts of those standards.

(2) Paragraph (1) also applies to system or process requirements to be fulfilled in accordance with this Part by economic operators or sponsors, including those relating to quality management systems, risk management, post market surveillance systems, performance studies, clinical evaluation or post-market performance follow-up (‘PMPF’).

Common specifications

144.(1) Subject to paragraphs (5) and (6), in this Part “common specifications” (CS) means common specifications which are—

(a)adopted by the European Commission in accordance with the procedure set down in Article 9(1) of Regulation (EU) 2017/746;

(b)designated by the Secretary of State by publishing a reference to the CS and maintaining that publication in a manner in which the Secretary of State considers appropriate.

(2) Devices that comply with CS adopted and designated in accordance with paragraph (1) or specified in regulations made under paragraph (5) are presumed to be in conformity with the requirements of this Part covered by CS or the relevant parts of the CS.

(3) Manufacturers must comply with CS adopted and designated in accordance with paragraph (1), or specified in regulations made under paragraph (6), unless they can justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent to the CS.

(4) When considering whether the manner of publication of a reference is appropriate in accordance with paragraph (1)(b), the Secretary of State must have regard to whether the publication will draw the CS to the attention of any person who may have an interest in the CS.

(5) The Secretary of State may cancel the designation by removing from publication the reference to the CS published in accordance with paragraph (1)(b) and, where he does so, that CS is no longer a CS.

(6) Where the European Commission have not adopted a common specification but the Secretary of State is of the opinion that a common specification is necessary to address urgent public health concerns, the Secretary of State may by regulations specify a CS and designate it in accordance with paragraph (1)(b).

General obligations of manufacturers

145.(1) When placing their devices on the market or putting them into service, manufacturers must ensure that they have been designed and manufactured in accordance with the requirements of this Part.

(2) Manufacturers must establish, document, implement and maintain a system for risk management as described in paragraph 3 of Schedule 17.

(3) Manufacturers must conduct a performance evaluation in accordance with the requirements set out in regulation 167 and Schedule 27, including a PMPF.

(4) Manufacturers must draw up and keep up to date the technical documentation for their devices.

(5) The technical documentation mentioned in paragraph (4) must—

(a)be such as to allow the conformity of the device with the requirements of this Part to be assessed;

(b)include the elements set out in Schedules 18 and 19.

(6) Where the Secretary of State considers it necessary in the light of technical progress, the Secretary of State may by regulations amend Schedules 18 and 19.

(7) Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than devices for performance study, must draw up a declaration of conformity in accordance with regulation 151, and affix the CE marking of conformity in accordance with regulation 152.

(8) Manufacturers must comply with the obligations relating to the UDI system referred to in regulation 157 and with the registration obligations referred to in regulations 158 and 160.

(9) Manufacturers must keep the technical documentation, the declaration of conformity and, if applicable, a copy of the relevant certificate (including any amendments and supplements) available for the Secretary of State for a period of at least 10 years after the last device covered by the declaration of conformity has been placed on the market.

(10) The Secretary of State may require a manufacturer to provide the technical documentation and such a request may be for the entirety of the documentation or for a summary.

(11) A manufacturer with place of business outside the United Kingdom must ensure that the person placing the product on the market has the necessary documentation permanently available.

(12) Manufacturers must ensure that procedures are in place to keep series production in conformity with the requirements of this Part including—

(a)ensuring that changes in product design or characteristics and changes in the standards or CS by reference to which the conformity of a product is declared are adequately, and in a timely manner, taken into account;

(b)ensuring that for devices (other than devices for performance study) a quality management system, which is proportionate to the risk class and type of device is established, documented, implemented, maintained, kept up to date and continually improved.

(13) The quality management system required by paragraph (12) must—

(a)cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures and devices;

(b)govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Part;

(c)provide details of at least the following—

(i)a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;

(ii)the identification of applicable general safety and performance requirements and exploration of options to address those requirements;

(iii)the responsibility of the management;

(iv)resource management, including selection and control of suppliers and sub-contractors;

(v)risk management as set out in paragraph 3 of Schedule 17;

(vi)performance evaluation, in accordance with regulation 167 and Schedule 27, including PMPF;

(vii)product realisation, including planning, design, development, production and service provision;

(viii)verification of the UDI assignments made in accordance with regulation 157 to all relevant devices and ensuring consistency and validity of information provided in accordance with regulation 158;

(ix)setting-up, implementation and maintenance of a post-market surveillance system, in accordance with regulation 185;

(x)processes for handling communication with the Secretary of State (and authorities in other states), notified bodies, other economic operators, customers and any other stakeholders;

(xi)management of corrective and preventive actions and verification of their effectiveness;

(xii)processes for monitoring and measurement of output, data analysis and product improvement.

(14) Manufacturers of devices must implement and keep up to date the post-market surveillance system in accordance with regulation 185.

(15) Manufacturers must ensure that—

(a)the device is accompanied by the information set out in paragraph 20 of Schedule 17 in English;

(b)the label is indelible, easily legible and clearly comprehensible to the intended user or patient.

(16) Manufacturers that consider or have reason to believe that a device which they have placed on the market or put into service is not in conformity with this Part must—

(a)immediately take the necessary corrective action to bring that device into conformity, to withdraw it or to recall it, as appropriate;

(b)inform the distributors of the device in question and, where applicable, the authorised representative, the UK responsible person and importers accordingly;

(c)where the device presents a serious risk, immediately inform the Secretary of State and, where applicable, the notified body that issued a certificate for the device in particular, of the non-compliance and of any corrective action taken.

(17) Manufacturers must have a system for recording and reporting of incidents and field safety corrective actions as described in regulations 190 and 191.

(18) Manufacturers must, when they are required to do so by the Secretary of State—

(a)provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of the device;

(b)cooperate with the Secretary of State on any corrective action needed to eliminate or, if that is not possible, mitigate the risks posed by the device which they have placed on the market or put into service;

(c)provide samples of the device free of charge or, where that is impracticable, grant access to the device.

(19) A manufacturer who fails to cooperate with a requirement imposed by paragraph (18) or who provides documentation which is incomplete or incorrect, may be subject to enforcement action under Part VII or to any other enforcement measures available to the Secretary of State under consumer protection legislation.

(20) Subject to the Data Protection Act 2018(68) and to the protection of any intellectual property rights, the Secretary of State must, where there is reason to believe that a device has caused damage and where a request is made in writing by a person in sub-paragraph (a), (b) or (c), facilitate the provision of the information and documentation mentioned in paragraph (18) to—

(a)any person who has been or could have been injured by the device;

(b)any person entitled to bring an action on behalf of the person in sub-paragraph (a); or

(c)any other person reasonably believed to have been affected by the damage caused by the device.

(21) The Secretary of State need not comply with the requirement in paragraph (20) where the disclosure of the information and documentation is to be dealt with in legal proceedings.

(22) Where a manufacturer has entered into an arrangement with another person to design or manufacture a device the identity of that other person must form part of the documentation submitted in accordance with regulation 160.

(23) Manufacturers must, taking account of the risk class of a device, the type of device and the size of the enterprise, hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability arising from damage caused by a device.

UK responsible person

146.  A person regarded as the UK responsible person must—

(a)ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

(b)keep available for inspection by the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

(c)in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

(d)forward to the manufacturer any request by the Secretary of State for samples, or access to a device and ensure that the Secretary of State receives the samples or has been given access to the device;

(e)cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

(f)immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;

(g)terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the Secretary of State and, if applicable, the relevant notified body of that termination.

General obligations of importers

147.(1) Importers must place on the market only devices which are in conformity with this Part.

(2) In order to place a device on the market, importers must ensure that—

(a)the device has been CE marked and that the declaration of conformity of the device has been drawn up;

(b)its manufacturer or, if applicable, its authorised representative, is identified;

(c)the device is labelled in accordance with this Part and accompanied by the required instructions for use;

(d)where applicable, a UDI has been assigned by the manufacturer in accordance with regulation 157.

(3) Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Part, the importer must—

(a)not place the device on the market until it has been brought into conformity;

(b)inform the manufacturer and, if applicable, the manufacturer’s authorised representative and UK responsible person;

(4) Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, the importer must also inform the Secretary of State.

(5) Importers must indicate on the device or on its packaging or in a document accompanying the device—

(a)their name;

(b)if applicable, their registered trade name or registered trade mark;

(c)if applicable, their registered place of business;

(d)the address at which they can be contacted.

(6) Importers must ensure that any additional label does not obscure any information on the label provided by the manufacturer.

(7) Importers must verify that the device has been registered with the Secretary of State and must add their name to the registration.

(8) Importers must —

(a)ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Schedule 17;

(b)comply with any conditions set by the manufacturer.

(9) Importers must keep a register of —

(a)complaints about devices;

(b)non-conforming devices;

(c)recalls of devices;

(d)withdrawals of devices;

and must provide the manufacturer and distributors with any information reasonably requested by them, in order to allow them to investigate complaints.

(10) Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Part must—

(a)immediately inform the manufacturer and, if applicable, the manufacturer’s authorised representative and UK responsible person;

(b)cooperate with the manufacturer, the manufacturer’s authorised representative and UK responsible person and the Secretary of State to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it, is taken.

(11) Where a device presents a serious risk, importers must immediately inform the Secretary of State and, if applicable, the notified body that issued a certificate, and must give details, in particular, of the non-compliance giving rise to the risk and of any corrective action taken.

(12) Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market must immediately forward this information to the manufacturer and, if applicable, the manufacturer’s authorised representative and UK responsible person.

(13) Importers must keep a copy of the declaration of conformity and any relevant certificate, for the period referred to in regulation 145(9).

(14) Importers must, if required by the Secretary of State to do so—

(a)cooperate with the Secretary of State on any action to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market;

(b)provide samples of a device or, if that is impractical, grant the Secretary of State access to the device.

General obligations of distributors

148.(1) When making a device available on the market, distributors must, in the context of their activities, comply with the requirements of this Part.

(2) Before making a device available on the market, distributors must ensure that all the following requirements are met—

(a)the device has been CE marked and that the declaration of conformity of the device has been drawn up;

(b)the device is accompanied by the information supplied by the manufacturer in accordance with regulation 145(15);

(c)for imported devices, the importer has complied with the requirements set out in regulation 147(8);

(d)where applicable, a UDI has been assigned by the manufacturer.

(3) In order to meet the requirements of sub-paragraphs (a), (b) and (d) of paragraph (2) the distributor may apply a sampling method that is representative of the devices supplied by the distributor.

(4) Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Part, the distributor must—

(a)not make the device available on the market until it has been brought into conformity;

(b)inform the manufacturer;

(c)where applicable, inform the importer.

(5) Where a distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, the distributor must, in addition to complying with paragraph (4) also inform the Secretary of State.

(6) Distributors must ensure that, while the device is under their responsibility, storage and transport conditions comply with the conditions set by the manufacturer.

(7) Where a distributor considers or has reason to believe that a device which it has made available on the market is not in conformity with this Part, the distributor must—

(a)inform the manufacturer and where applicable, the manufacturer’s authorised representative, UK responsible person and the importer;

(b)cooperate with the manufacturer, with the Secretary of State, where applicable, with the manufacturer’s authorised representative, the UK responsible person and with the importer to ensure the necessary corrective action to bring the device into conformity, to withdraw or to recall the device, is taken.

(8) Where the distributor considers or has reason to believe that a device which it has made available on the market presents a serious risk it must immediately inform the Secretary of State.

(9) Distributors must, unless the relevant information will be provided by another economic operator, upon request by the Secretary of State, provide the Secretary of State with all the information at their disposal and necessary to demonstrate the conformity of the device.

(10) Distributors must, at the Secretary of State’s request—

(a)cooperate with the Secretary of State on any action taken to eliminate the risks posed by devices which they have made available on the market;

(b)provide free samples of the device or, if that is impractical, grant the Secretary of State access to the device.

Person responsible for regulatory compliance

149.(1) Subject to paragraph (4), manufacturers must have available within their organisation at least one person who is responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices.

(2) Subject to paragraph (3), the requisite expertise in paragraph may be demonstrated by either of the following—

(a)a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised by the Secretary of State as equivalent in—

(i)law;

(ii)medicine;

(iii)pharmacy;

(iv)engineering; or

(v)another relevant scientific discipline,

and at least one year of professional experience in regulatory affairs management relating to medical devices;

(b)4 years of professional experience in—

(i)regulatory affairs; or

(ii)in quality management systems relating to in vitro diagnostic medical devices.

(3) Where a manufacturer manufacturers custom-made devices the requisite experience may be demonstrated by having at least 2 years of professional expertise within a relevant field of manufacturing.

(4) Micro and small businesses, within the meaning of Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises(69) (as it applies in European Union law), are not required to have a person responsible for regulatory compliance within their organisation but must have such a person permanently and continuously at their disposal.

(5) The person responsible for regulatory compliance must at least be responsible for ensuring that—

(a)the conformity of devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before the device is released;

(b)the technical documentation and declaration of conformity are drawn up and kept up-to date;

(c)the post market surveillance obligations are complied with in accordance with regulation 145(14);

(d)the reporting obligations referred to in regulations 190 to 193 are fulfilled;

(e)in the case of investigational devices, the statement referred to in paragraph 3(a) of Chapter II of Schedule 28 is issued.

(6) If a number of persons are jointly responsible for regulatory compliance their respective areas of responsibility must be stipulated in writing.

(7) The person responsible for regulatory compliance must not suffer any disadvantage within the manufacturer’s organisation in relation to the person’s proper fulfilment of their duties, regardless of whether or not they are employees of the organisation.

Cases in which obligations of manufacturers apply to importers, distributors or other persons

150.(1) A distributor, importer or other person has the obligations of a manufacturer if that person does any of the following—

(a)makes available on the market a device under its name, registered trade name or registered mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Part;

(b)changes the intended purpose of a device already placed on the market or put into service;

(c)modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected;

(2) Paragraph (1) does not apply to a person who, without changing its intended purpose, assembles or adapts for an individual patient a device which is already on the market.

(3) For the purposes of paragraph (1)(c) the following are not to be considered to be a modification of a device that could affect its compliance with the applicable requirements—

(a)provision of information supplied by the manufacturer, in accordance with paragraph 20 of Schedule 17, relating to a device already on the market and of further information which is necessary in order to market the device;

(b)changes to the outer packaging of a device already placed on the market, including a change of the pack size, if the repackaging is carried out in such conditions that the original condition of the device cannot be affected but, for devices placed on the market in a sterile condition, the original condition of the device must be presumed to be adversely affected if the packaging necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.

(4) A distributor or importer that carries out any of the activities mentioned in paragraph (3) must indicate on the device or, where that is impractical, on the packaging or in a document accompanying the device—

(a)the activity carried out;

(b)the name of the importer or distributor;

(c)any registered trade name or trade mark of the importer or distributor;

(d)the registered place of business and the address at which the importer or distributor can be contacted.

(5) Distributors and importers who carry out the activities in paragraph (3) must have a quality management system in place which—

(a)ensures that the activities in paragraph (3) are performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy;

(b)contains procedures which ensure that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in order to respond to safety issues or to bring the device into conformity with this Part.

(6) At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities in paragraph (3) must—

(a)inform the manufacturer and the Secretary of State of the intention to make a relabelled or repackaged device available;

(b)upon request, provide the manufacturer and the Secretary of State with a sample or mock-up of the relabelled or repackaged device (including any translated label and instructions for use);

(c)submit to the Secretary of State a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in paragraph (3), attesting that the quality management system of the distributor or importer complies with the requirements laid down in paragraphs (4) and (5).

Declaration of conformity

151.(1) The declaration of conformity must state that the requirements specified in this Part, or the equivalent provisions of Regulation (EU) 2017/746, have been fulfilled in relation to the device that is covered and the manufacturer must continuously update the declaration of conformity.

(2) The declaration of conformity must, at least, contain the information set out in Schedule 20 and must be in English.

(3) Where a device is subject to other legislation which requires a declaration of conformity by the manufacturer, a single declaration of conformity must be drawn up in respect of all the legislation applicable to the device and must contain the information required for identification of the legislation to which the declaration relates.

(4) By drawing up the declaration of conformity, the manufacturer assumes responsibility for compliance with the requirements of this Part and all other legislation applicable to the device.

CE marking of conformity

152.(1) Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements of this Part must bear the CE marking of conformity, as presented in Schedule 21.

(2) The CE marking—

(a)must be affixed visibly, legibly and indelibly to the device or its sterile packaging;

(b)where such affixing is not possible or not warranted on account of the nature of the device, must be affixed to the packaging;

(c)must also appear in any instructions for use and on any sales packaging.

(3) The CE marking must be affixed before the device is placed on the market and it may be followed by a pictogram or any other mark indicating a special risk or use.

(4) Where applicable, the CE marking must be followed by the identification number of the notified body responsible for the conformity assessment procedures set out in regulation 163 and the identification number must also be indicated in any promotional material which mentions that a device fulfils the requirements for CE marking.

(5) Where devices are subject to other legislation which also provides for the affixing of the CE marking, the CE marking must indicate that the devices also fulfil the requirements of that other legislation.

Devices for special purposes

153.(1) The Secretary of State must not create obstacles to devices for performance study being supplied to an investigator for the purpose of a clinical investigation if they meet the requirements of this Part.

(2) The devices to which paragraph (1) relates must not bear a CE marking.

(3) The Secretary of State must not create obstacles to the showing of devices, which do not comply with this Part, at trade fairs, exhibitions, demonstrations or similar events provided that the following conditions are met—

(a)a visible sign clearly indicates that such a device are intended for presentation or demonstration purposes;

(b)that such a device cannot be made available until it has been brought into compliance with this Part.

Parts and components

154.(1) Any person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, must—

(a)ensure that the item does not adversely affect the safety and performance of the device;

(b)keep supporting evidence available for the Secretary of State.

(2) An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device is considered to be a device and must meet the requirements laid down in this Part.

Identification and traceability of devices, registration of devices and of economic operators, summary of safety and performance and clinical performance

Identification within the supply chain

155.(1) Distributors and importers must cooperate with manufacturers (or the manufacturer’s authorised representative and UK responsible person) to achieve an appropriate level of traceability of devices.

(2) Economic operators must, where applicable, be able to identify the following to the Secretary of State, for the period referred to in regulation 145(9)—

(a)any economic operator to whom they have directly supplied a device;

(b)any economic operator who has directly supplied them with a device;

(c)any health institution or healthcare professional to which they have directly supplied a device.

Medical devices nomenclature

156.(1) The Secretary of State must ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other persons required by this Part to use that nomenclature.

(2) The Secretary of State must also endeavour to ensure that nomenclature is available to other stakeholders free of charge, where reasonably practicable.

Unique device identification system

157.(1) ‘UDI system’ must consist of –

(a)production of a UDI that comprises—

(i)a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Schedule 22;

(ii)a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Schedule 22;

(b)placing of the UDI on the label of the device or on its packaging;

(c)storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs (8) and (9) respectively;

(d)establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with regulation 159.

(2) Before placing a device, other than a device for performance study, on the market, the manufacturer must assign to the device and, if applicable, to all higher levels of packaging, a UDI created in compliance with the rules of an issuing entity.

(3) Before a device, other than a device for performance study, is placed on the market the manufacturer must ensure that the information referred to in Part B of Schedule 22 about the device is correctly submitted and transferred to the UDI database referred to in regulation 92.

(4) UDI carriers must be placed on the label of the device and on all higher levels of packaging but “higher levels of packaging” does not include shipping containers.

(5) The UDI must be used for reporting serious incidents and field safety corrective actions in accordance with regulation 190.

(6) The Basic UDI-DI of the device must appear on the declaration of conformity referred to in regulation 151.

(7) As part of the technical documentation referred to in Schedule 18 the manufacturer must keep up-to-date a list of the UDIs that it has assigned.

(8) Economic operators must store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to the devices, categories or groups of devices determined by regulations made under paragraph (10).

(9) The Secretary of State may require healthcare institutions or healthcare professionals to store and keep, preferably by electronic means, the UDI of the devices with which they have been supplied.

(10) The Secretary of State may by regulations—

(a)determine the devices, categories or groups of devices mentioned in paragraph (8);

(b)amend the list of information set out in Part B of Schedule 22 in the light of technical progress;

(c)amend Schedule 22 in the light of international developments and technical progress.

(11) In this regulation and regulation 158 “issuing entity” means an organisation designated by the European Commission for the purpose of issuing UDIs pursuant to Regulation 2017/746 of the European Parliament and the Council of 5th April 2017 as it applies in the European Union(70).

Registration of devices (ex Art 26)

158.(1) Before placing a device, other than a custom-made device, on the market, the manufacturer must, in accordance with the rules of the issuing entity referred to in regulation 157(2), assign a Basic UDI-DI to the device and must provide it to the UDI database together with the other core data elements referred to in Part B of Schedule 22 related to that device.

(2) Where a manufacturer is not established in the United Kingdom, the UK responsible person must ensure that the manufacturer has complied with paragraph (1).

Electronic system for registration of economic operators

159.(1) The Secretary of State must set up and manage an electronic system to create a registration number for the purpose of identifying the manufacturer and, where applicable, the importer, authorised representative, the UK responsible person and distributor.

(2) The details of the information to be provided to the electronic system are set out in paragraph 1 of Part A of Schedule 22.

Registration of economic operators

160.(1) No person may place a device on the market unless that person is—

(a)established in the United Kingdom;

(b)has complied with paragraph (2).

(2) Before placing a device on the market—

(a)a manufacturer must register with the electronic system referred to in regulation 159 and provide the information set out in paragraph 1 of Part A of Schedule 22;

(b)where there is no manufacturer established in the United Kingdom, the person placing the product on the market is to be regarded as the UK responsible person and that person must register with the electronic system referred to in regulation 159.

(3) Unless they have already registered as a person within paragraph (2)(b), importers must also provide the relevant information in paragraph 1 of Part A of Schedule 22.

(4) Within one week of a change occurring in the information referred to in paragraph (2), the person must update the information in the electronic system referred to in regulation 159.

(5) Not later than one year after the submission of the information referred to in paragraph (2), and every second year after that, the person must confirm the accuracy of the information.

(6) Notwithstanding the person’s responsibility for the accuracy of the information, the Secretary of State must verify the information provided under paragraph (2).

(7) The information entered in the electronic system must be accessible to the public.

(8) The Secretary of State may use the information provided under paragraph (2) for the purpose of charging a fee in connection with carrying out the activities set out in this Part.

Summary of safety and performance

161.(1) For Class C and D devices, other than devices for performance studies, a manufacturer must draw up a summary of safety and performance.

(2) The summary of safety and performance must be written in a way that is clear to the intended user and, if applicable, to the patient and must be made available to the public.

(3) The manufacturer must state on the label or the instructions for use where the summary of safety and performance can be found.

(4) The summary of safety and clinical performance must include at least the following—

(a)identification of the device and the manufacturer including the Basic UDI-DI;

(b)the intended purpose of the device, any indications or contraindications and the target populations;

(c)a description of the device, including a reference to any previous generations or variants and a description of the differences;

(d)where relevant, a description of any accessories, other devices and products which are intended to be used in combination with the device;

(e)possible diagnostic therapeutic alternatives;

(f)the summary of performance evaluation as referred to in Schedule 27, and relevant information on PMPF;

(g)suggested profile and training for users;

(h)information on any residual risks and any undesirable side effects, warnings and precautions.

(5) The Secretary of State may by regulations set out the form and presentation of the data elements to be included in the summary of safety and performance.

Classification of devices

162.  Devices to which this Part applies must be divided into Classes A, B, C and D, according to the classification rules in Schedule 23.

Conformity assessment procedures

163.(1) Before placing a device on the market, putting a device into service or making a device available on the market, a person must ensure that the manufacturer has undertaken an assessment of the conformity of the device in accordance with the applicable conformity assessment procedures outlined in paragraphs (2) to (10) and set out in Schedules 24 to 26.

(2) Class D devices, other than devices for performance study, must be subject to—

(a)a conformity assessment as specified in Parts 1 and 3 of Schedule 24; or

(b)a conformity assessment as specified in Schedule 25 coupled with a conformity assessment as specified in Schedule 26.

(3) In addition to the procedures in paragraph (2) for Class D devices for self-testing and near patient testing, the manufacturer must follow the procedure for technical documentation assessment set out in paragraph 3 of Schedule 24.

(4) Class C devices, other than devices for performance study, must be subject to conformity assessment procedure—

(a)as specified in Parts 1 and 3 of Schedule 24, including an assessment of the technical documentation of at least one representative device per generic device group; or

(b)as specified in Schedule 25 coupled with a conformity assessment as specified in Schedule 26 (except for paragraph 4).

(5) In addition to the procedures in paragraph (4) for Class C devices for self-testing and near patient testing, the manufacturer must follow the procedure for technical documentation assessment set out in paragraph 3 of Schedule 24.

(6) Class B devices, other than devices for performance study, must be subject to a conformity assessment as specified in Parts 1 and 3 of Schedule 24, including an assessment of the technical documentation for at least one representative device per category of devices.

(7) In addition to the procedures in paragraph (6) for Class B devices for self-testing and near patient testing, the manufacturer must follow the procedure for technical documentation assessment set out in paragraph 3 of Schedule 24.

(8) Subject to paragraph (9), Class A devices, other than devices for performance study, must declare the conformity of their products by issuing a declaration of conformity referred to in regulation 151, after drawing up the technical documentation set out in Schedules 18 and 19.

(9) If Class A devices are placed on the market in a sterile condition, the manufacturer must apply the procedures set out in Schedule 24 or in Schedule 26.

(10) Devices for performance study must be subject to the requirements of regulations 168 to 185.

Involvement of notified bodies

164.(1) Where the conformity assessment procedure requires the involvement of a notified body, the manufacturer may apply to a notified body of its choice, provided that the chosen notified body is designated for conformity assessment activities related to the types of devices concerned.

(2) The manufacturer may not lodge an application in parallel with another notified body for the same conformity assessment procedure.

Exceptions to conformity assessment and CE marking etc.

165.(1) The requirements of regulation 164 do not apply where—

(a)on request, the Secretary of State has authorised the placing on the market, making available on the market or putting into service within the United Kingdom of a specific device;

(b)where that authorisation is granted for the purpose of protecting public health or patient safety or health.

(2) Except for the requirement to register in accordance with regulations 158 or 160, the requirements of this Part do not apply where the Secretary of State directs that a relevant device (or a class of relevant devices), which meets other requirements or standards (or which is marked other than with a CE marking) which the Secretary of State considers to be equivalent to the requirements and standards imposed by this Part, may be placed on the market.

(3) In paragraph (2), a standard or requirement is equivalent to a standard or requirement imposed by this Part if, in respect of the relevant device (or class of relevant devices), the standard or requirement provides for an equivalent level of safety and quality to that imposed by this Part.

Certificate of free sale

166.(1) For the purpose of export and upon request by a manufacturer, the Secretary of State must issue a certificate of free sale declaring that the manufacturer has its registered place of business in the United Kingdom and that the device in question, bearing the CE marking in accordance with this Part, may be marketed in the United Kingdom.

(2) The certificate of free sale must set out the Basic UDI-DI of the device as provided to the UDI database under regulation 92 and, where a notified body has issued a certificate, the certificate of free sale must set out the unique number identifying the certificate issued by the notified body.

Clinical evaluation, performance evaluation and performance studies

Performance evaluation and clinical evidence

167.(1) Confirmation of conformity with relevant general safety and performance requirements set out in Schedule 17, in particular those concerning the performance characteristics referred to in Part 1 and paragraph 9 of Schedule 17, under the normal conditions of the intended use of the device, and the evaluation of the interference and cross-reactions and of the acceptability of the benefit-risk ratio referred to in paragraphs 1 and 8 of Schedule 17, must be based on scientific validity, analytical and clinical performance data providing sufficient clinical evidence, including where applicable relevant data as referred to in Schedule 19.

(2) The manufacturer must specify and justify the level of the clinical evidence necessary to demonstrate conformity with the relevant general safety and performance requirements and that level of clinical evidence must be appropriate in view of the characteristics of the device and its intended purpose.

(3) Manufacturers must plan, conduct and document a performance evaluation in accordance with this regulation and with Part A of Schedule 27.

(4) The clinical evidence must support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation, following a performance evaluation plan.

(5) A performance evaluation must follow a defined and methodologically sound procedure for the demonstration of the following, in accordance with this regulation and with Part A of Schedule 27—

(a)scientific validity;

(b)analytical performance;

(c)clinical performance.

(6) The data and conclusions drawn from the assessment of the elements in paragraph (5) must constitute the clinical evidence for the device and the clinical evidence must be such as to scientifically demonstrate, by reference to the state of the art in medicine, that the intended clinical benefit will be achieved and that the device is safe.

(7) The clinical evidence derived from the performance evaluation must provide scientifically valid assurance, that the relevant general safety and performance requirements set out in Schedule 17, are fulfilled, under normal conditions of use.

(8) Clinical performance studies in accordance with paragraph 2 of Part A of Schedule 27 must be carried out unless it is duly justified to rely on other sources of clinical performance data.

(9) The scientific validity data, the analytical performance data and the clinical performance data, their assessment and the clinical evidence derived from that data, shall be documented in the performance evaluation report referred to in paragraph 1(21) to (22) of Part A of Schedule 27.

(10) The performance evaluation report must be part of the technical documentation, referred to in Schedule 18, relating to the device concerned.

(11) The performance evaluation and its documentation shall be updated throughout the life cycle of the device concerned with data obtained from implementation of the manufacturer’s PMPF plan in accordance with Part B of Schedule 27 and the post-market surveillance plan referred to in regulation 187.

(12) The performance evaluation report for Class C and D devices must be updated when necessary, but at least annually, with the data referred to in the paragraph (11) and the summary of safety and performance referred to in regulation 161 must be updated as soon as possible, where necessary.

General requirements regarding performance studies

168.(1) The manufacturer must ensure that a device for performance study complies with the general safety and performance requirements set out in Schedule 17 apart from the aspects covered by the performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the patient, user and other persons.

(2) Where appropriate, performance studies must be performed in circumstances similar to the normal conditions of use of the device.

(3) Performance studies must be designed and conducted in such a way that the rights, safety, dignity and well-being of the subjects participating in such performance studies are protected and prevail over all other interests and the data generated are scientifically valid, reliable and robust.

Additional requirements for certain performance studies

169.(1) Any performance study—

(a)in which surgically invasive sample-taking is done only for the purpose of the performance study;

(b)that is an interventional clinical performance study; or

(c)where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies,

must, in addition to meeting the requirements set out in regulation 168 and Schedule 27, be designed, authorised, conducted, recorded and reported in accordance with this regulation, regulations 170 to 185 and Schedule 28.

(2) Performance studies involving companion diagnostics must be subject to the same requirements as the performance studies listed in paragraph (1).

(3) Paragraph (2) does not apply to performance studies involving companion diagnostics using only left-over samples but such studies must be notified to the Secretary of State.

(4) Performance studies must be subject to scientific and ethical review performed by an ethics committee whose procedures for review are compatible with the procedures for the assessment of an application for authorisation of a performance study set out in this Part.

(5) Where the sponsor of a performance study is not established in the United Kingdom—

(a)that sponsor shall ensure that a person is established in the United Kingdom as its legal representative;

(b)such legal representative shall be responsible for ensuring compliance with the sponsor’s obligations pursuant to this Part, and must be the addressee for all communications with the sponsor provided for in this Part; and

(c)any communication with that legal representative must be deemed to be a communication with the sponsor.

(6) A performance study as referred to in paragraph (1) may be conducted only where all of the following conditions are met—

(a)the performance study is the subject of an authorisation by the Secretary of State in accordance with this Part, unless otherwise stated;

(b)an ethics committee has not issued a negative opinion in relation to the performance study;

(c)the sponsor or its legal representative or a contact person pursuant to paragraph (5) is established in the United Kingdom;

(d)vulnerable populations and subjects are appropriately protected in accordance with regulations 170 to 174;

(e)the anticipated benefits to the subjects or to public health justify the foreseeable risks and inconveniences and compliance with this condition is constantly monitored;

(f)the subject or, where the subject is not able to give informed consent, his or her legally designated representative has given informed consent, in accordance with regulation 170;

(g)the subject or, where the subject is not able to give informed consent, his or her legally designated representative, has been provided with the contact details of an entity where further information can be received in case of need;

(h)the rights of the subject to physical and mental integrity, to privacy and to the protection of the data concerning him or her in accordance with the Data Protection Act 2018 are safeguarded;

(i)the performance study has been designed to involve as little pain, discomfort, fear and any other foreseeable risk as possible for the subjects, and both the risk threshold and the degree of distress are specifically defined in the performance study plan and constantly monitored;

(j)the medical care provided to the subjects is the responsibility of an appropriately qualified medical doctor or, where appropriate, any other person authorised health professional entitled to provide the relevant patient care under performance study conditions;

(k)no undue influence, including that of a financial nature, is exerted on the subject, or, where applicable, on his or her legally designated representatives, to participate in the performance study;

(l)where appropriate, biological safety testing reflecting the latest scientific knowledge or any other test deemed necessary in the light of the device’s intended purpose has been conducted;

(m)in the case of clinical performance studies, the analytical performance has been demonstrated, taking into consideration the state of the art;

(n)in the case of interventional clinical performance studies, the analytical performance and scientific validity has been demonstrated, taking into consideration the state of the art and where, for companion diagnostics, the scientific validity is not established, the scientific rationale for the use of the biomarker shall be provided;

(o)the technical safety of the device with regard to its use has been proven, taking into consideration the state of the art as well as provisions in the field of occupational safety and accident prevention;

(p)the requirements of Schedule 28 are fulfilled.

(7) Any subject, or, where the subject is not able to give informed consent, his or her legally designated representative, may, without any resulting detriment and without having to provide any justification, withdraw from the performance study at any time by revoking his or her informed consent.

(8) Subject to the Data Protection Act 2018, the withdrawal of the informed consent in accordance with paragraph (7) must not affect the activities already carried out and the use of data obtained based on informed consent before its withdrawal.

(9) The investigator must be an authorised health professional qualifying for the role of investigator on account of having the necessary scientific knowledge and experience in patient care or laboratory medicine and other personnel involved in conducting a performance study must be suitably qualified, by education, training or experience in the relevant medical field and in clinical research methodology, to perform their tasks.

(10) Where appropriate, the facilities where the performance study involving subjects is to be conducted must be suitable for the performance study and shall be similar to the facilities where the device is intended to be used.

Informed consent

170.(1) Informed consent—

(a)must be written, dated and signed by the person performing the interview referred to in paragraph 170(2)(c), and by the subject or, where the subject is not able to give informed consent, his or her legally designated representative after having been duly informed in accordance with paragraph 170(2);

(b)may, where the subject is unable to write, be given and recorded through appropriate alternative means in the presence of at least one impartial witness and, in that case, the witness must sign and date the informed consent document;

(c)must be documented and a copy of that document or record must be provided to the subject or the subject’s legally designated representative;

(d)is only valid if adequate time is given for the subject, or the subject’s legally designated representative to consider their decision to participate in the performance study.

(2) Information given to the subject or, where the subject is not able to give informed consent, his or her legally designated representative for the purposes of obtaining his or her informed consent must—

(a)enable the subject or his or her legally designated representative to understand—

(i)the nature, objectives, benefits, implications, risks and inconveniences of the performance study;

(ii)the subject’s rights and guarantees regarding his or her protection, in particular his or her right to refuse to participate in and the right to withdraw from the performance study at any time without any resulting detriment and without having to provide any justification;

(iii)the conditions under which the performance study is to be conducted, including the expected duration of the subject’s participation in the performance study;

(iv)the possible treatment alternatives, including the follow-up measures if the participation of the subject in the performance study is discontinued;

(b)be kept comprehensive, concise, clear, relevant, and understandable to the subject or the subject’s legally designated representative;

(c)be provided in a prior interview with a member of the investigating team who is appropriately qualified; and

(d)include information about the applicable damage compensation system referred to in regulation 175.

(3) The information referred to in paragraph (2) must be prepared in writing and be available to the subject or, where the subject is not able to give informed consent, his or her legally designated representative.

(4) In the interview referred to in paragraph (2)(c)—

(a)special attention must be paid to the information needs of specific patient populations and of individual subjects, as well as to the methods used to give the information;

(b)the member of the investigating team must ensure that the subject has understood the information.

(5) The subject must be informed that a performance study report and a summary presented in terms understandable to the intended user will be made available irrespective of the outcome of the performance study, and must be informed, to the extent possible, when they have become available.

(6) A minor who is capable of forming an opinion and assessing the information given to him or her, must also assent in order to participate in a clinical investigation.

Performance studies on incapacitated subjects

171.(1) In the case of incapacitated subjects who have not given, or have not refused to give, informed consent before the onset of their incapacity, a performance study may be conducted only where, in addition to the conditions set out in regulation 169(6), all of the following conditions are met—

(a)unless regulation 174 applies, the informed consent of their legally designated representative has been obtained;

(b)unless regulation 174 applies, the incapacitated subjects have received the information referred to in regulation 171 in a way that is adequate in view of their capacity to understand it;

(c)the explicit wish of an incapacitated subject who is capable of forming an opinion and assessing the information referred to in regulation 170(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;

(d)no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study;

(e)the performance study is essential with respect to incapacitated subjects and data of comparable validity cannot be obtained in performance studies on persons able to give informed consent, or by other research methods;

(f)the performance study relates directly to a medical condition from which the subject suffers;

(g)there are scientific grounds for expecting that participation in the performance study will produce—

(i)a direct benefit to the incapacitated subject outweighing the risks and burdens involved; or

(ii)some benefit for the population represented by the incapacitated subject concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the incapacitated subject concerned in comparison with the standard treatment of the incapacitated subject’s condition.

(2) The subject must, as far as possible, take part in the informed consent procedure.

Performance studies on minors

172.  A performance study on minors may be conducted only where, in addition to the conditions set out in regulation 169(6) all of the following conditions are met—

(a)the informed consent of their legally designated representative has been obtained;

(b)the minors have received the information referred to in regulation 170(2) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children;

(c)the explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in regulation 170(2) to refuse participation in, or to withdraw from, the performance study at any time, is respected by the investigator;

(d)no incentives or financial inducements are given to subjects or their legally designated representatives, except for compensation for expenses and loss of earnings directly related to the participation in the performance study;

(e)the performance study is intended to investigate treatments for a medical condition that only occurs in minors or the performance study is essential with respect to minors to validate data obtained in performance studies on persons able to give informed consent or by other research methods;

(f)the performance study either relates directly to a medical condition from which the minor concerned suffers or is of such a nature that it can only be carried out on minors;

(g)there are scientific grounds for expecting that participation in the performance study will produce—

(i)a direct benefit to the minor subject outweighing the risks and burdens involved; or

(ii)some benefit for the population represented by the minor concerned when the performance study will pose only minimal risk to, and will impose minimal burden on, the minor concerned in comparison with the standard treatment of the minor’s condition;

(h)the minor must take part in the informed consent procedure in a way adapted to his or her age and mental maturity;

(i)if, during a performance study, a person reaches the age of 16 years, that person’s express informed consent must be obtained before they can continue to participate in the clinical investigation.

Performance studies on pregnant or breastfeeding women

173.  A performance study on a pregnant or breastfeeding woman may be conducted only where, in addition to the conditions set out in regulation 169(6), all of the following conditions are met—

(a)the performance study has the potential to produce a direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, outweighing the risks and burdens involved;

(b)if such a performance study has no direct benefit for the pregnant or breastfeeding woman concerned, or her embryo, foetus or child after birth, it can be conducted only if—

(i)a performance study of comparable effectiveness cannot be carried out on women who are not pregnant or breastfeeding;

(ii)the performance study contributes to the attainment of results capable of benefitting pregnant or breastfeeding women or other women in relation to reproduction or other embryos, foetuses or children; and

(iii)the performance study poses a minimal risk to, and imposes a minimal burden on, the pregnant or breastfeeding woman concerned, her embryo, foetus or child after birth;

(c)where research is undertaken on breastfeeding women, particular care is taken to avoid any adverse impact on the health of the child;

(d)no incentives or financial inducements are given to subjects, except for compensation for expenses and loss of earnings directly related to the participation in the performance study.

Performance studies in emergency situations

174.(1) Informed consent to participate in a performance study may be obtained, and information on the performance studies may be given, after the decision to include the subject in the performance study, provided that that decision is taken at the time of the first intervention on the subject, in accordance with the clinical performance study plan for that performance study and that all of the following conditions are fulfilled—

(a)due to the urgency of the situation, caused by a sudden life-threatening or other sudden serious medical condition, the subject is unable to provide prior informed consent and to receive prior information on the performance study;

(b)there are scientific grounds to expect that participation of the subject in the performance study will have the potential to produce a direct clinically relevant benefit for the subject resulting in a measurable health-related improvement alleviating the suffering or improving the health of the subject, or in the diagnosis of its condition;

(c)it is not possible within the therapeutic window to supply all prior information to and obtain prior informed consent from the subject’s legally designated representative;

(d)the investigator certifies that they are not aware of any objections to participate in the performance study previously expressed by the subject;

(e)the performance study relates directly to the subject’s medical condition because of which it is not possible within the therapeutic window to obtain prior informed consent from the subject or from his or her legally designated representative and to supply prior information, and the performance study is of such a nature that it may be conducted exclusively in emergency situations;

(f)the performance study poses a minimal risk to, and imposes a minimal burden on, the subject in comparison with the standard treatment of the subject’s condition.

(2) Where paragraph (1) applies, informed consent in accordance with regulation 170 must be sought to continue the participation of the subject in the performance study, and information on the performance study must be given, in accordance with the following requirements—

(a)for incapacitated subjects and minors, the informed consent must be sought by the investigator from the subject’s legally designated representative without undue delay and the information referred to in regulation 170(2) must be given as soon as possible to the subject and to the subject’s legally designated representative;

(b)for all other subjects, the informed consent must be sought by the investigator without undue delay from the subject or the subject’s legally designated representative, whichever can be done sooner, and the information referred to in regulation 170(2) must be given as soon as possible to the subject or his or her legally designated representative, as applicable.

(3) For the purposes of paragraph (2)(b), where informed consent has been obtained from the legally designated representative, informed consent to continue the participation in the performance study must be obtained from the subject as soon as the subject is capable of giving informed consent.

(4) Where consent is not given, the subject or, where applicable, the subject’s legally designated representative must be informed of the right to object to the use of data obtained from the performance study.

Damage compensation

175.  Sponsors must, taking account of the risk class of a device, the type of device and the size of the enterprise, hold sufficient insurance (or equivalent financial resources) to meet any potential financial liability arising from damage caused by a performance study.

Application for performance studies

176.(1) The sponsor of a performance study must submit an application to the Secretary of State accompanied by the documentation referred to in paragraphs 2 and 3 of Schedule 27 and in Schedule 28.

(2) Within 10 days of receiving the application, the Secretary of State must notify the sponsor as to whether the performance study falls within the scope of this Part and as to whether the application dossier is complete in accordance with Part 1 of Schedule 28.

(3) Within one week of any change occurring in relation to the documentation referred to in Part 1 of Schedule 28, the sponsor must—

(a)update the relevant data;

(b)make that change to the documentation clearly identifiable;

(c)notify the Secretary of State of the update.

(4) Where the Secretary of State finds that the performance study applied for does not fall within the scope of this Part or that the application dossier is not complete, the Secretary of State must inform the sponsor and must set a time limit of maximum 10 days for the sponsor to comment, but the Secretary of State may extend this period by a maximum of 20 days where appropriate.

(5) Where—

(a)the sponsor has not provided comments within the time limit referred to in the paragraph (4), the application must be deemed to have lapsed;

(b)the sponsor considers the application does fall under the scope of this Part or is complete but the Secretary of State does not, the application must be considered to have been rejected.

(6) The Secretary of State must notify the sponsor within 5 days of receipt of the comments or of the requested additional information, whether the performance study is considered as falling within the scope of this Part or, as the case maybe, whether the application is complete.

(7) The Secretary of State may extend the notification periods referred to in paragraphs (2) and (6) each by a further 5 days.

(8) The validation date of the application is to be considered—

(a)the date on which the sponsor is notified in accordance with paragraphs (2) and (6); or

(b)where the sponsor is not notified, the last day of the periods referred to in paragraph (4).

(9) The sponsor may start the clinical investigation in the following circumstances—

(a)in the case of performance studies in which surgically invasive sample-taking is done only for the purpose of the performance study, provided that a negative opinion has not been issued by an ethics committee in the United Kingdom in respect of the performance study, immediately after the validation date of the application pursuant to paragraph (8);

(b)in the case of performance studies, carried out pursuant to regulation 169(b) or (c) or performance studies other than those referred to in sub-paragraph (a), provided a negative opinion in respect of the clinical investigation has not been issued by an ethics committee in the United Kingdom, as soon as the Secretary of State has notified the sponsor of the Secretary of State’s authorisation.

(10) For the purposes of paragraph (9)(b) the Secretary of State must notify the sponsor of the authorisation within 45 days of the validation date referred to in paragraph (8) and the Secretary of State may extend this period by a further 20 days for the purpose of consulting with experts.

Assessment by Secretary of State

177.(1) The Secretary of State must ensure that the persons validating and assessing the performance study application, or deciding on it do not have conflicts of interest and in particular are—

(a)independent of—

(i)the sponsor;

(ii)the investigators involved;

(iii)the person financing the performance study;

(b)free of any undue influence.

(2) The Secretary of State must ensure that the assessment is done jointly by an appropriate number of persons who collectively have the necessary qualifications and experience.

(3) The Secretary of State—

(a)must assess whether the performance study is designed in such a way that potential remaining risks to subjects or third persons, after risk minimization, are justified, when weighed against the clinical benefits to be expected;

(b)must, while taking into account applicable CS or designated standards, examine in particular—

(i)the demonstration of compliance of the devices for performance study with the applicable general safety and performance requirements, apart from the aspects covered by the performance study, and whether, with regard to those aspects, every precaution has been taken to protect the health and safety of the subjects and this includes, where appropriate, the evaluation of the analytical performance, clinical performance and scientific validity, taking into consideration the state of the art;

(ii)whether the risk-minimisation solutions employed by the sponsor are described in designated standards and, in those cases where the sponsor does not use those standards, whether the risk-minimisation solutions provide a level of protection that is equivalent to that provided by those standards;

(iii)whether the measures planned for the safe installation, putting into service and maintenance of the device for performance study are adequate;

(iv)the reliability and robustness of the data generated in the performance study, taking account of statistical approaches, design of the investigation and methodological aspects, including sample size, comparator and endpoints;

(v)whether the requirements of Schedule 28 are met.

(4) The Secretary of State must refuse the authorisation of the performance study if—

(a)the application dossier submitted remains incomplete;

(b)the device or the submitted documents, especially the performance study plan and the investigator’s brochure, do not correspond to the state of scientific knowledge, and the performance study, in particular, is not suitable for providing evidence for the safety, performance characteristics or benefit of the device on subjects or patients;

(c)the requirements of regulation 168 are not met; or

(d)any assessment under paragraph (3) is negative.

Appeal rights

178.(1) Where the sponsor is dissatisfied with a decision taken by the Secretary of State under regulation 176(6) or regulation 177(4), the sponsor or the sponsor’s legally designated representative in the United Kingdom may require the Secretary of State to seek advice from such a person as the Institute determines on—

(a)whether the performance study falls within this Part; or

(b)whether the Secretary of State correctly refused the authorisation.

(2) Where the sponsor acts in accordance with paragraph (1), the sponsor is responsible for the fees, costs and expenses of the Institute and of the person appointed by the Institute.

(3) In this regulation, “Institute” means the charitable organisation with registered number 803725 and known as the Chartered Institute of Arbitrators.

Conduct of performance study

179.(1) The sponsor and the investigator must ensure that the performance study is conducted in accordance with the approved performance study plan.

(2) The sponsor—

(a)must ensure adequate monitoring of the conduct of the performance study in order to—

(i)verify that the rights, safety and wellbeing of the subjects are protected;

(ii)that the reported date are reliable and robust;

(iii)that the conduct of the performance study is in compliance with the requirements of this Part;

(b)must determine the extent and nature of the monitoring on the basis of an assessment taking into consideration all the characteristics of the performance study including the following—

(i)the objective and methodology of the performance study;

(ii)the degree of deviation of the intervention from normal clinical practice.

(3) All performance study information must be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the Data Protection Act 2018.

(4) Appropriate technical and organisational measures must be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves transmission over a network.

(5) The Secretary of State must inspect, at an appropriate level, performance study sites to check that performance studies are conducted in accordance with the requirements of this Part and with the approved investigation plan.

(6) The sponsor must establish a procedure for emergency situations which enables the immediate identification and, where necessary, an immediate recall of the devices used in the study.

Performance studies regarding devices bearing the CE marking -intended purpose

180.(1) Where—

(a)a performance study is to be conducted to further assess, within the scope of its intended purpose, a device which already bears the CE marking in accordance with regulation 152(1) (‘PMPF study’);

(b)the performance study would involve submitting subjects to procedures additional to those performed under the normal conditions of use of the device and those additional procedures are invasive or burdensome;

the sponsor must notify the Secretary of State at least 30 days prior to its commencement.

(2) The sponsor must include the documentation referred to in paragraph 2 of Part A of Schedule 27 and in Schedule 28.

(3) The following provisions apply to PMPF studies—

(a)sub-paragraphs (b) to (l) and (p) of paragraph 169;

(b)regulations 182, 183, 184 and 185(6) and the relevant provisions of Schedules 27 and 28.

Performance studies regarding devices bearing the CE marking outside intended purpose

181.  Where a performance study is to be conducted to assess, outside the scope of its intended purpose, a device which already bears the CE marking in accordance with regulation 152(1), regulations 168 to 185 apply.

Substantial modifications to performance studies

182.(1) If a sponsor intends to introduce modifications to a performance study that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the data generated by the study, the sponsor must—

(a)within one week of deciding to introduce modifications, notify the Secretary of State of the reasons for and the nature of those modifications;

(b)include an updated version of the relevant documentation referred to in Schedule 28 as part of the notification;

(c)ensure that changes to the relevant documentation are clearly identifiable.

(2) The Secretary of State must assess any substantial modification to the performance study in accordance with the procedure laid down in regulation 177.

(3) The sponsor may implement the modifications referred to in paragraph (1) at the earliest 38 days after the notification referred to in paragraph (1)(a), unless—

(a)the Secretary of State has notified the sponsor of its refusal based on the grounds referred to in regulation 177(4) or on considerations of public health, of subject and user safety or health, or of public policy; or

(b)an ethics committee has issued a negative opinion in relation to the substantial modification to the performance study.

(4) The Secretary of State may extend the period referred to in paragraph (3) by a further 7 days, for the purpose of consulting experts.

Corrective measures to be taken by the Secretary of State on performance studies

183.(1) Where the Secretary of State has grounds for considering that the requirements of this Part are not met, the Secretary of State may take any of the following actions—

(a)revoke the authorisation for the performance study;

(b)suspend or terminate the performance study;

(c)require the sponsor to modify any aspect of the performance study.

(2) Before the Secretary of State takes any of the measures referred to in paragraph (1), the Secretary of State must, except where immediate action is required, ask the sponsor or the investigator for their opinion which must be delivered within 7 days.

Information from the sponsor at the end of a performance study or in the event of a temporary halt or early termination

184.(1) Subject to paragraph (2) if the sponsor has temporarily halted a performance study or has terminated a performance study early, the sponsor must inform the Secretary of State of that halt or termination within 15 days of the date of the temporary halt or termination.

(2) Where the sponsor has temporarily halted the performance study or terminated early it early on safety grounds, the sponsor must inform the Secretary of State of that halt or termination within 24 hours.

(3) The end of a performance study is deemed to coincide with the last visit of the last subject unless another point in time for such an end is set out in the performance study plan.

(4) The sponsor must notify the Secretary of State of the end of the performance study and that notification must be made within 15 days of the end of the performance study.

(5) Irrespective of the outcome of the performance study but subject to paragraph (7), within one year of the end of the performance study or within 3 months of the early termination or temporary halt, the sponsor must submit to the Secretary of State a performance study report as referred to in paragraph 1(10) to (12) of Part A of Schedule 27.

(6) The performance study report must—

(a)be accompanied by a summary presented in terms that are easily understandable to the intended user;

(b)be submitted by the sponsor to the Secretary of State along with the summary.

(7) Where, for scientific reasons, it is not possible to submit the performance study report within one year of the end of the study it must—

(a)be submitted as soon as it is available;

(b)specify in the clinical performance study plan referred to in sub-paragraphs (6) to (8) of Part A of Schedule 27 when the results of the performance study are going to be available, together with a justification for why the report cannot be submitted within one year of the end of the investigation.

(8) The Secretary of State may—

(a)issue guidelines regarding the content and structure of the summary of the performance study report;

(b)issue guidelines for the formatting and sharing of raw data, for cases where the sponsor decides to share raw data on a voluntary basis (and may take as a basis and adapt, where possible, existing guidelines for sharing of raw data in the field of performance studies.

(9) The summary and performance study report referred to in paragraph (6) must—

(a)in circumstances other than those provided for in sub-paragraphs (b) and (c), become publicly accessible at least when it is registered in accordance with regulation 158 and before it is placed on the market;

(b)in cases of early termination or temporary halt, become publicly accessible after submission;

(c)if the device is not registered in accordance with regulation 158, become publicly accessible within one year of the summary and the report having been submitted pursuant to paragraph (6).

Recording and reporting of adverse events that occur during performance studies

185.(1) The sponsor must fully record all of the following—

(a)any adverse event of a type identified in the performance study plan as being critical to the evaluation of the results of that performance study;

(b)any serious adverse event;

(c)any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(d)any new findings in relation to any event referred to in sub-paragraphs (a) to (c).

(2) The sponsor must report, without delay (but having regard to paragraph (3)) to the Secretary of State, all of the following—

(a)any serious adverse event that has a causal relationship with the device, the comparator or the study procedure or where such causal relationship is reasonably possible;

(b)any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;

(c)any new findings in relation to any event referred to in points (a) and (b).

(3) The period for reporting must take account of the severity of the event and, where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete followed up by a complete report.

(4) Upon request by the Secretary of State, the sponsor shall provide all information referred to in paragraph (1).

(5) The sponsor must also report to the Secretary of State any event referred to in paragraph (2) that occurred in a country outside the United Kingdom in which a performance study is performed under the same clinical performance study plan as the one applying to a performance study covered by this Part.

(6) Subject to paragraph (7), this regulation does not apply to PMPF studies referred to in regulation 180 but the provisions on vigilance provided for in regulations 190 to 193 apply instead of this regulation.

(7) This regulation must apply where a causal relationship between the serious adverse event and the preceding performance study has been established.

Post-market surveillance, vigilance and market surveillance

Post market surveillance system of the manufacturer

186.(1) For each device manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device and that system must be an integral part of the manufacturer’s quality management system referred to in regulation 145(13).

(2) The post-market surveillance system must be suited to—

(a)actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime;

(b)drawing the necessary conclusions; and

(c)determining, implementing and monitoring any preventive and corrective actions.

(3) The manufacturer must ensure that—

(a)data gathered by the manufacturer’s post-market surveillance system is used in particular—

(i)to update the benefit-risk determination and to improve the risk management as referred to in Part 1 of Schedule 17;

(ii)to update the design and manufacturing information, the instructions for use and the labelling;

(iii)to update the performance evaluation;

(iv)to update the summary of safety and performance referred to in regulation 161;

(v)for the identification of needs for preventive, corrective or field safety corrective action;

(vi)for the identification of options to improve the usability, performance and safety of the device;

(vii)when relevant, to contribute to the post-market surveillance of other devices; and

(viii)detect and report trends in accordance with 191;

(b)the technical documentation is updated accordingly.

(4) If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer must—

(a)implement the appropriate measures and inform the Secretary of State and, where applicable, the notified body;

(b)where a serious incident is identified or a field safety corrective action is implemented, it must be reported in accordance with regulation 190.

Post-market surveillance plan

187.  The post-market surveillance system referred to in regulation 186 must be based on a post-market surveillance plan which satisfies the requirements set out in paragraph 1 of Schedule 19 and must be part of the technical documentation specified in Schedule 18.

Post-market surveillance report

188.(1) Manufacturers of Class A and B devices must prepare a post-market surveillance report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in regulation 187 together with a rationale and description of any preventive and corrective actions taken.

(2) The report must be updated when necessary and made available to the notified body and the Secretary of State upon request.

Periodic safety update report

189.(1) Manufacturers of Class C and Class D devices must prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in regulation 187, together with a rationale and description of any preventive and corrective actions taken.

(2) Throughout the lifetime of the device concerned, that PSUR must set out—

(a)the conclusions of the benefit-risk determination;

(b)the main findings of the PMPF; and

(c)the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

(3) Manufacturers of Class C and D devices must—

(a)update the PSUR at least annually;

(b)ensure that the PSUR is part of the technical documentation as specified in Schedules 18 and 19.

(4) Manufacturers of Class D devices must—

(a)submit PSUR to the notified body involved in the conformity assessment of such devices in accordance with regulation 163;

(b)make the PSUR available to the Secretary of State.

(5) For Class C devices, manufacturers must make PSURs available to the notified body involved in the conformity assessment and, upon request, to the Secretary of State.

Reporting of serious incidents and field safety corrective actions

190.(1) Manufacturers of devices, made available on the market, other than devices for performance study must report to the Secretary of State the following—

(a)any serious incident involving devices made available on the market, except expected erroneous results which are clearly documented and quantified in the product information, in the technical documentation and are subject to trend reporting pursuant to regulation 191;

(b)any field safety corrective action in respect of devices made available on the market, including any field safety corrective action undertaken in a country outside the United Kingdom in relation to a device which is also legally made available on the market, if the reason for the field safety corrective action is not limited to the device made available in the country outside the United Kingdom.

(2) The period for the reporting referred to in paragraph (1) must take account of the severity of the serious incident.

(3) Manufacturers must report any serious incident as referred to in paragraph (1)(a) immediately after they have established a causal relationship between that incident and their device or that such causal relationship is reasonably possible, and not later than 15 days after they become aware of the incident.

(4) Notwithstanding paragraph (3), in the event of a serious public health threat the report referred to in paragraph (1) shall be provided immediately, and not later than 2 days after the manufacturer becomes aware of that threat.

(5) Notwithstanding paragraph (3), in the event of death or an unanticipated serious deterioration in a person’s state of health the report shall be provided immediately after the manufacturer has established or as soon as it suspects a causal relationship between the device and the serious incident but not later than 10 days after the date on which the manufacturer becomes aware of the serious incident.

(6) Where necessary to ensure timely reporting, the manufacturer may submit an initial report that is incomplete followed up by a complete report.

(7) If, after becoming aware of a potentially reportable incident, the manufacturer is uncertain about whether the incident is reportable, it shall nevertheless submit a report within the timeframe required in accordance with paragraphs (2) to (5).

(8) Except in cases of urgency in which the manufacturer needs to undertake field safety corrective action immediately, the manufacturer shall, without undue delay, report the field safety corrective action referred to in paragraph (1)(b), in advance of the field safety corrective action being undertaken.

(9) For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the Secretary of State has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting.

(10) The Secretary of State must—

(a)take appropriate measures such as organising targeted information campaigns, to encourage and enable healthcare professionals, users and patients to report to the Secretary of State suspected serious incidents referred to in paragraph (1)(a);

(b)record reports received from healthcare professionals, users and patients.

(11) Where the Secretary of State obtains reports on suspected serious incidents referred to in paragraph (1)(a) from healthcare professionals, users or patients, the Secretary of State must take the necessary steps to ensure that the manufacturer of the device concerned is informed of the suspected serious incident without delay.

(12) Where the manufacturer of the device concerned considers that the incident is a serious incident, it shall provide a report in accordance with paragraphs (1) to (5) on that serious incident to the Secretary of State and shall take the appropriate follow-up action in accordance with Article 192.

(13) Where—

(a)the manufacturer of the device concerned considers that the incident is not a serious incident or is to be treated as an increase in expected erroneous results, which will be covered by trend reporting in accordance with to regulation 191, the manufacturer must provide an explanatory statement; and

(b)the Secretary of State does not agree with the conclusion of the explanatory statement, the Secretary of State may require the manufacturer—

(i)to provide a report in accordance with paragraphs (1) to (5); and

(ii)to ensure that appropriate follow-up action is taken in accordance with regulation 192.

Trend reporting

191.(1) Manufacturers must report to the Secretary of State any statistically significant increase in the frequency or severity of incidents that are not serious incidents that could have a significant impact on the benefit-risk analysis referred to in paragraphs 1 and 5 of Schedule 17 and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in paragraph 9(1) of Schedule 17 and specified in the technical documentation and product information.

(2) The manufacturer must specify how to manage the incidents referred to in paragraph (1) and the methodology used for determining any statistically significant increase in the frequency or severity of such events or change in performance, as well as the observation period, in the post-market surveillance plan referred to in regulation 187.

(3) The Secretary of State may conduct assessments on the trend reports referred to in paragraph (1) and require the manufacturer to adopt appropriate measures in accordance with this Part in order to ensure the protection of public health and patient safety.

Analysis of serious incidents and field safety corrective actions

192.(1) Following the reporting of a serious incident pursuant to regulation 190(1), the manufacturer must—

(a)without delay, perform the necessary investigations in relation to the serious incident and the devices concerned;

(b)include, as part of that investigation, a risk assessment of the incident and field safety corrective action taking into account the criteria as referred to in paragraph (4)(a) as appropriate.

(2) The manufacturer must—

(a)cooperate with the Secretary of State and where relevant with the notified body concerned during the investigations referred to in paragraph (1);

(b)not perform any investigation which involves altering the device or a sample of the batch concerned in a way which may affect any subsequent evaluation of the causes of the incident, prior to informing the Secretary of State of such action.

(3) The Secretary of State must take the necessary steps to ensure that any information regarding a serious incident that has occurred, or a field safety corrective action that has been or is to be undertaken, and that is brought to the Secretary of State’s knowledge in accordance with regulation 190 is evaluated, if possible together with the manufacturer, and, where relevant, the notified body concerned.

(4) In the context of the evaluation referred to in paragraph (3), the Secretary of State must evaluate—

(a)the risks arising from the reported serious incident and evaluate any field safety corrective actions, taking into account the protection of public health and criteria such as—

(i)causality, detectability and probability of recurrence of the problem;

(ii)frequency of use of the device;

(iii)probability of occurrence of direct or indirect harm;

(iv)the severity of that harm;

(v)the clinical benefit of the device;

(vi)the intended and potential users;

(vii)the population affected;

(b)the adequacy of the field safety corrective action envisaged or undertaken by the manufacturer and the need for, and kind of, any other corrective action, in particular taking into account the principle of inherent safety contained in Schedule 17.

(5) Upon request by the Secretary of State, manufacturers must provide for all documents necessary for the risk assessment.

(6) The Secretary of State must monitor the manufacturer’s investigation of a serious incident and, where necessary, may intervene in a manufacturer’s investigation or initiate an independent investigation.

(7) The manufacturer must provide a final report to the Secretary of State setting out the manufacturer’s findings from the investigation which must set out conclusions and, where relevant, indicate corrective actions to be taken.

(8) The manufacturer must ensure that information about the field safety corrective action taken—

(a)is brought without delay to the attention of users of the device in question by means of a field safety notice;

(b)except in cases of urgency, the content of the draft field safety notice must be submitted to the Secretary of State to allow the Secretary of State to make comments.

(9) The field safety notice must—

(a)allow the correct identification of the device or devices involved;

(b)explain, in a clear manner, without understating the level of risk, the reasons for the field safety corrective action with reference to the device malfunction and associated risks for patients, users or other persons;

(c)must clearly indicate all the actions to be taken by users;

(d)be accessible to the public.

Analysis of vigilance data

193.(1) The Secretary of State must put in place systems and processes to actively monitor the data available in order to identify trends, patterns or signals in the data that may reveal new risks or safety concerns.

(2) Where a previously unknown risk is identified or the frequency of an anticipated risk significantly and adversely changes the benefit-risk determination, the Secretary of State must inform the manufacturer, or where applicable the UK responsible person, which shall then take the necessary corrective actions.

Electronic system on vigilance and post-market surveillance

194.(1) The Secretary of State must set up and mange an electronic system to collate and process the following information

(a)reports by manufacturers on serious incidents and field safety corrective actions;

(b)the periodic summary reports by manufacturers;

(c)the reports by manufacturers on trends;

(d)the PSURs;

(e)the field safety notices by issued by manufacturers.

(2) The Secretary of State must ensure that healthcare professionals and the public receive appropriate information contained in the electronic system referred to in paragraph (1).

(3) The Secretary of State—

(a)may make arrangements with other countries or international organisations for the purposes of granting access (at an appropriate level) to the electronic system in paragraph (1);

(b)must only make such arrangements on the basis of reciprocity;

(c)must base any such arrangements on data protection rules equivalent to those applicable in the United Kingdom.

Market surveillance

Market surveillance activities

195.(1) The Secretary of State must—

(a)perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples;

(b)in doing so, take account of established principles regarding risk assessment and risk management, vigilance data and complaints.

(2) The Secretary of State must—

(a)draw up annual surveillance activity plans;

(b)allocate a sufficient number of material and competent human resources in order to carry out those activities.

(3) In order to fulfil the obligations in paragraph (1), the Secretary of State—

(a)may require economic operators to make available the documentation and information necessary for the purpose of carrying out the authorities’ activities and, where justified, to provide the necessary samples of devices or access to devices free of charge;

(b)must carry out both announced and, if necessary, unannounced inspections of the premises of economic operators, as well as suppliers or subcontractors, and, where necessary, at the facilities of professional users.

(4) The Secretary of State must prepare and publish an annual summary of the results of surveillance activity.

(5) The Secretary of State may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where the Secretary of State deems it necessary to do so in the interests of the protection of public health.

(6) Following each inspection carried out for the purposes referred to in paragraph (1), the Secretary of State must—

(a)draw up a report on the findings of the inspection that concern compliance with the requirements under this Part;

(b)set out in the report any corrective actions needed.

(7) The Secretary of State must—

(a)communicate the content of the report referred to in paragraph (6) to the economic operator that has been the subject of the inspection;

(b)before adopting the final report, give that economic operator the opportunity to submit comments.

(8) The Secretary of State must—

(a)at least every 4 years, review and assess the functioning of the market surveillance activities; and

(b)make a summary of the results of that review available to the public.

(9) Where appropriate, the Secretary of State must cooperate with other countries with a view to exchanging information, providing technical support and promoting activities relating to market surveillance.

Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance

196.  Where the Secretary of State, based on data obtained by vigilance or market surveillance activities or on other information, has reason to believe that a device—

(a)may present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health; or

(b)otherwise does not comply with the requirements laid down in this Part,

the Secretary of State must carry out an evaluation of the device concerned covering all requirements laid down in this Part relating to the risk presented by the device or to any other non-compliance of the device and the relevant economic operators must cooperate with the Secretary of State.

Procedure for dealing with devices presenting an unacceptable risk to health and safety

197.(1) Where, having performed an evaluation pursuant to regulation 196, the Secretary of State finds that the device presents an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the Secretary of State—

(a)must without delay require the manufacturer of the devices concerned and all other relevant economic operators to take all appropriate and duly justified corrective action to bring the device into compliance with the requirements of this Part relating to the risk presented by the device;

(b)may, in a manner that is proportionate to the nature of the risk, restrict the making available of the device on the market, subject the making available of the device to specific requirements, withdraw the device from the market, or to recall it within a reasonable period that is clearly defined and communicated to the relevant economic operator.

(2) The economic operators referred to in paragraph (1) must, without delay, ensure that all appropriate corrective action is taken throughout the United Kingdom in respect of all the devices concerned that they have made available on the market.

(3) Where the economic operator as referred to in paragraph (1) does not take adequate corrective action within the period referred to in paragraph (1), the Secretary of State may take action in accordance with regulation 63 or Part II of the Consumer Protection Act 1987.

Other non-compliance

198.(1) Where, having performed an evaluation pursuant to regulation 196, the Secretary of State finds that a device does not comply with the requirements laid down in this Part but does not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health, the Secretary of State must require the relevant economic operator to bring the non-compliance concerned to an end within a reasonable period that is clearly defined and communicated to the economic operator and that is proportionate to the non- compliance.

(2) Where the economic operator does not bring the non-compliance to an end within the period referred to in paragraph (1), the Secretary of State may take action in accordance with regulation 62 or, following such action, Part II the Consumer Protection Act 1987.

Regulations

199.(1) Regulations under this Part may—

(a)make different provisions for different purposes or different areas;

(b)make consequential, incidental, transitional or supplemental provision.

(2) A power to make regulations under this Part is exercisable by statutory instrument.

(3) A statutory instrument which contains regulations under this Part is subject to annulment in pursuance of a resolution of each House of Parliament..

PART 4New Schedules to the 2002 Regulations

12.  After Schedule 2 to the 2002 Regulations insert—

Regulation 1A

SCHEDULE 2AModification of Annexes to Directives 90/385, 93/42, 98/79

PART 1Modification of Annexes to Directive 90/385

1.  The Annexes to Directive 90/385 are modified so that they read as if amended by paragraphs 2 to 8.

2.  In Annex 1 for Section 10 substitute—

10.  Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations 2012, and which is liable to act upon the body with an action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by Schedule 8B to the Human Medicines Regulations 2012(71).

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes..

3.  In Annex 2—

(a)in Section 2, omit “established within the Community”;

(b)in Section 3.3, for the first sentence substitute—

The quality system shall be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(c)of Section 3.4, in the second paragraph, for the first sentence substitute—

The proposed modifications shall be evaluated by the notified body so as to verify whether the quality system so modified would still meet the requirements referred to in Section 3.2.;

(d)omit Section 4.3;

(e)in Section 6.1, after “national authorities” insert “and the Secretary of State”;

(f)for Section 6.2, substitute—

6.2.  On request, a UK notified body shall make available to other notified bodies and to the Secretary of State all relevant information relating to the withdrawal of its approval for a quality system.;

(g)in Section 7, for the words “issued by” to the end, substitute—

a laboratory designated for the purpose by an EU Member State in accordance with Article 114(2) of Directive 2001/83/EC or a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012(72)..

4.  In Annex 3—

(a)in Section 2, omit “established in the Community”;

(b)omit Sections 4 and 5;

(c)for Section 7.1 substitute—

7.1.  On request, a UK notified body shall make available to other notified bodies (including other UK notified bodies) and to the Secretary of State all relevant information on EC type-examination certificates and addenda to those certificates.;

(d)for Section 7.2 substitute—

7.2.  A UK notified body must cooperate with other notified bodies (including other UK notified bodies) with regard to making available copies of the EC type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other notified bodies with the consent of the manufacturer..

5.  In Annex 4—

(a)in Sections 1 and 2, omit “established within the Community” in each place where those words appear;

(b)in Section 5, for the first sentence substitute—

A product must have had, in respect of it, the appropriate examinations and tests carried out by a notified body to check the conformity of the product to the requirements of this Directive by examination and testing of products on a statistical basis as specified in Section 6.;

(c)in Section 6.4, for the first two paragraphs substitute—

Where the notified body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.;

(d)in Section 7, for the words from “issued by” to the end, substitute “a laboratory designated for the purpose by an EU Member State in accordance with Article 114(2) of Directive 2001/83/EC or a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

6.  In Annex 5—

(a)in Section 2, in the second paragraph, omit “established within the Community”;

(b)in Section 3.3, for the first sentence substitute—

The quality system shall be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(c)in Section 3.4, for the first sentence of the second paragraph—

The proposed modifications shall be evaluated by the notified body so as to verify whether the quality system modified would meet the requirements referred to in Section 3.2;

7.  In Annex 6, in Section 1, omit “established within the Community”.

8.  In Annex 8—

(a)in the title for “when designating” substitute “by”;

(b)in Section 6, omit the words from “unless liability” to the end of that Section.

PART 2Modification of Annexes to Directive 93/42

9.  The Annexes to Directive 93/42 are modified so that they read as if amended by paragraphs 10 to 19.

10.  In Annex I—

(a)for Section 7.4 substitute—

7.4.  Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in regulation 2 of the Human Medicines Regulations, and which is liable to act upon the body with action ancillary to that of the device, the quality, safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC as modified by the Human Medicines Regulations;

Where changes are made to an ancillary substance incorporated in a device, in particular related to its manufacturing process, the notified body shall be informed of the changes..

(b)in Section 8.2, omit the second paragraph;

(c)in Section 13.3 in point (f), omit the second sentence.

11.  In Annex II—

(a)in Section 1 omit “Community”;

(b)in Section 3.3, for the first sentence substitute—

The quality system must be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(c)in Section 3.4, for the second sentence substitute—

The proposed changes must be assessed by the notified body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.;

(d)omit Section 4.3;

(e)in Section 6.1, after “national authorities” insert “and the Secretary of State”;

(f)in Section 8, for the words “issued by” to the end of that Section, substitute “a laboratory designated for the purpose by an EU Member State in accordance with Article 114(2) of Directive 2001/83/EC or a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

12.  In Annex III—

(a)in Section 2, in the second indent, for the last line substitute, “The applicant shall provide samples as necessary at the request of the notified body,”;

(b)omit Sections 4 to 5;

(c)for Section 7.2 substitute—

7.2.  A UK notified body must cooperate with other notified bodies (including other UK notified bodies) with regard to making available copies of the EC type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other notified bodies with the consent of the manufacturer..

13.  In Annex IV—

(a)omit Sections 4 to 5.2;

(b)omit Sections 6.2 and 6.3;

(c)in Section 6.4, for the first two paragraphs, substitute—

Where the notified body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market.;

(d)in Section 7, after “national authorities” insert “and the Secretary of State”;

(e)in Section 9, from the words “issued by” to the end of that Section, substitute “a laboratory designated for the purpose by an EU Member State in accordance with Article 114(2) of Directive 2001/83/EC or a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012.”.

14.  In Annex V—

(a)in Section 1, omit “Community”;

(b)in Section 3.3 for the first sentence substitute—

The quality system must be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(c)in Section 3.4, for the last two paragraphs, substitute—

The proposed changes must be evaluated by the notified body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.;

(d)in Section 5.1, after “national authorities”, insert “and the Secretary of State”;

(e)omit Section 6.4.

(f)in Section 7, for the words from “issued by” to the end of that Section, substitute—

a laboratory designated for the purpose by an EU Member State in accordance with Article 114(2) of Directive 2001/83/EC or a laboratory provided or arranged in accordance with section 57(1)(d) of the Health and Social Care Act 2012..

15.  In Annex VI—

(a)in Section 3.3, for the first sentence substitute—

The quality system must be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(b)in Section 3.4, for the second paragraph substitute—

The proposed changes must be assessed by the notified body so as to verify whether the quality system after these changes would still meet the requirements referred to in Section 3.2.

(c)in Section 5.1, after “national authorities”, insert “and the Secretary of State”.

16.  In Annex VII—

(a)in Section 2, after “national authorities”, insert “and the Secretary of State”;

(b)in Section 4, after “competent authorities”, insert “and the Secretary of State”;

(c)in Section 5, omit “and the intervention by the notified body.”.

17.  In Annex VIII, in Section 3 after “national authorities”, insert “and the Secretary of State”.

18.  In Annex X, in Section 2.3.5, after “competent authorities of the Member States”, insert “and the Secretary of State”.

19.  In Annex XI

(a)in the title, for “for the designation of” substitute “by”;

(b)in Section 2, for “national authorities” substitute “the Secretary of State”;

(c)in Section 6, omit the words from “unless liability” to the end of that Section.

PART 3Modification of Annexes to Directive 98/79

20.  The Annexes to Directive 98/79 are modified so that they read as if amended by paragraphs 21 to 27.

21.  In Annex I—

(a)in Section 8.1, omit the sixth paragraph;

(b)in Section 8.4, in point (a), after “distribution in the Community” insert “or the United Kingdom”.

22.  In Annex III—

(a)in Section 5, after “competent authorities”, insert “and the Secretary of State”;

(b)omit Section 6.2;

23.  In Annex IV—

(a)in Section 3.3 for the first sentence substitute—

The quality system must be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(b)in Section 3.4, in the second paragraph, for the first sentence , substitute—

The proposed changes must be assessed by the notified body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2.;

(c)omit Section 4.3.

24.  In Annex V—

(a)in Section 2, in the second paragraph, at the end of the second indent, omit “.The notified body may request other samples as necessary”;

(b)omit Sections 4 and 5;

(c)for Section 7 substitute—

A UK notified body must cooperate with other notified bodies (including other UK notified bodies) with regard to making available copies of the EC type examination certificates or addenda to those certificates but, as regards copies of annexes to the certificates, must only make those available to other notified bodies with the consent of the manufacturer..

25.  In Annex VI—

(a)omit Sections 4 and 5;

(b)omit Sections 6.2 and 6.3;

(c)for the first two paragraphs of Section 6.4, substitute—

Where the notified body has drawn up a written certificate of conformity in relation to a batch, all products in that batch to which that body has affixed, or caused to be affixed, an identification number may be placed on the market..

26.  In Annex VII—

(a)in Section 3.3 for the first sentence substitute—

The quality system must be audited by the notified body to determine whether it meets the requirements referred to in Section 3.2.;

(b)for the second paragraph of Section 3.4, substitute—

The proposed changes must be assessed by the notified body so as to verify whether the quality system after these changes would meet the requirements referred to in Section 3.2..

27.  In Annex IX—

(a)in the heading, omit the words “the designation of”;

(b)in Section 2, for “national authorities” substitute “the Secretary of State”;

(c)in Section 6, omit the words from “unless liability” to the end of that Section.

Regulation 1A

SCHEDULE 3General safety and performance requirements for general medical devices

PART 1General requirements

1.  Devices must—

(a)achieve the performance intended by their manufacturer;

(b)be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose;

(c)be safe and effective and not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.

2.  The requirement in this Schedule to reduce risks as far as possible means the reduction of risks as far as possible without adversely affecting the benefit-risk ratio.

3.(1) Manufacturers must establish, implement, document and maintain a risk management system.

(2) Risk management is to be understood as a continuous iterative process throughout the entire lifecycle of a device, which requires regular systematic updating and, in carrying out risk management, manufacturers must—

(a)establish and document a risk management plan for each device;

(b)identify and analyse the known and foreseeable hazards associated with each device;

(c)estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse;

(d)eliminate or control the risks referred to in sub-paragraph (c) in accordance with the requirements of paragraph 4;

(e)evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability;

(f)based on the evaluation of the impact of the information referred to in paragraph (e), if necessary amend control measures in line with the requirements of paragraph 4.

4.(1) Risk control measures adopted by manufacturers for the design and manufacture of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.

(2) To reduce risks, manufacturers must manage risks so that the residual risk associated with each hazard as well as the overall residual risk is judged acceptable.

(3) In selecting the most appropriate solutions, manufacturers must, in the following order of priority—

(a)eliminate or reduce risks as far as possible through safe design and manufacture;

(b)where appropriate, take adequate protection measures, including alarms if necessary, in relation to risks that cannot be eliminated; and

(c)provide information for safety (warnings, precautions, contra-indications) and, where appropriate, training to users;

(d)inform users of any residual risks.

5.  In eliminating or reducing risks related to use error, the manufacturer must—

(a)reduce as far as possible the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety);

(b)give consideration to the technical knowledge, experience, education, training and use environment, where applicable, and the medical and physical conditions of intended users (design for lay, professional, disabled or other users).

6.  The characteristics and performance of a device must not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.

7.  Devices must be designed, manufactured and packaged in such a way that their characteristics and performance during their intended use are not adversely affected during transport and storage, for example, through fluctuations of temperature and humidity, taking account of the instructions and information provided by the manufacturer.

8.  All known and foreseeable risks, and any undesirable side-effects, must be minimised and be acceptable when weighed against the evaluated benefits to the patient or user arising from the achieved performance of the device during normal conditions of use.

9.  For the devices referred to in Schedule 16, the general safety requirements set out in paragraphs 1 and 8 must be understood to mean that the device, when used under the conditions and for the purposes intended, does not present a risk at all or presents a risk that is no more than the maximum acceptable risk related to the product’s use which is consistent with a high level of protection for the safety and health of persons.

PART 2Requirements regarding design and manufacture

Chemical, physical and biological properties

10.(1) Devices must be designed and manufactured in such a way as to ensure that the characteristics and performance requirements referred to in paragraphs 1 to 9 are fulfilled.

(2) Particular attention must be paid to—

(a)the choice of materials and substances used, particularly as regards toxicity and, where relevant, flammability;

(b)the compatibility between the materials and substances used and biological tissues, cells and body fluids, taking account of the intended purpose of the device and, where relevant, absorption, distribution, metabolism and excretion;

(c)the compatibility between the different parts of a device which consists of more than one implantable part;

(d)the impact of processes on material properties;

(e)where appropriate, the results of biophysical or modelling research the validity of which has been demonstrated beforehand;

(f)the mechanical properties of the materials used, reflecting, where appropriate, matters such as strength, ductility, fracture resistance, wear resistance and fatigue resistance;

(g)surface properties;

(h)the confirmation that the device meets any defined chemical or physical specifications.

(3) Devices must be designed, manufactured and packaged in such a way as to minimise the risk posed by contaminants and residues to—

(a)patients, taking account of the intended purpose of the device;

(b)persons involved in the transport, storage and use of the device,

and particular attention must be paid to tissues exposed to those contaminants and residues and to the duration and frequency of exposure.

(4) Devices must be designed and manufactured in such a way that they can be used safely with the materials and substances, including gases, with which they enter into contact during their intended use.

(5) If the devices are intended to administer medicinal products they must—

(a)be designed and manufactured in such a way as to be compatible with the medicinal products concerned in accordance with the provisions and restrictions governing those medicinal products;

(b)ensure that the performance of both the medicinal products and of the devices is maintained in accordance with their respective indications and intended use.

Substances
Design and manufacture of devices

(6) Devices must be designed and manufactured in such a way as to reduce, as far as possible, the risks posed by substances or particles, including wear debris, degradation products and processing residues that may be released from the device.

(7) Devices, parts of those devices or materials used in those devices listed in sub-paragraph (8) may only contain the following substances in a concentration that is above 0.1% weight where that is justified in accordance with sub-paragraph (9)—

(a)substances which are carcinogenic, mutagenic or toxic to reproduction (‘CMR’), of category 1A or 1B, and on the UK mandatory classification and labelling list established and maintained in accordance with Article 38A(73) of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006; or

(b)substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified in accordance with—

(i)the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC; or

(ii)Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out the scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) 528/2012 of the European Parliament and Council.

(8) The devices (or parts or materials) to which sub-paragraph (7) relates are devices which—

(a)are invasive and come into direct contact with the human body;

(b)administer or re-administer medicines, body liquids or other substances, including gases, to the body; or

(c)transport or store medicines, body fluids or substances, including gases, to be administered or re-administered to the body.

(9) The justification for the presence of the substances listed in sub-paragraph (7) must be based upon—

(a)an analysis and estimation of potential patient or user exposure to the substance;

(b)an analysis of possible alternative substances, materials or designs, including, where available, information about independent research, peer-reviewed studies, scientific opinions from relevant scientific committees and an analysis of the availability of such alternatives;

(c)arguments as to why possible substance or material substitutes, if available, or design changes, if feasible, are inappropriate in relation to maintaining the functionality, performance and the benefit-risk ratios of the product; including, where relevant having regard to the intended use of the device, taking account of the vulnerability to such substances or materials of particular patient groups including children and pregnant or breastfeeding women;

(d)where applicable and available, the latest scientific guidelines relating to the risks and benefits (including the availability of alterative substances, materials, designs or treatments) of phthalates and other CMR and endocrine-disrupting substances.

Labelling

(10) Where the devices (parts or materials) referred to in sub-paragraph (7) contain the substances in paragraph (a) and (b) of sub-paragraph (7) in a concentration above 0.1% weight by weight (w/w), the presence of those substances must—

(a)be labelled on the device itself or on the packaging for each unit or, where appropriate, on the sales packaging, with the list of such substances;

(b)if the intended use of such devices includes treatment of particular patient groups (including children or pregnant or breastfeeding women) who are particularly vulnerable to those substances, be contained in information on residual risks for those patient groups and, if applicable, in appropriate precautionary measures in the instructions for use.

(11) Devices must be designed and manufactured in such a way as to reduce, as far as possible, the risks posed by the unintentional ingress of substances into the device, taking into account the device and the nature of the environment in which it is intended to be used.

(12) Unless they come into contact with intact skin only, devices must be designed and manufactured in such a way as to reduce, as far as possible, the risks linked to the size and the properties of particles which are or can be released into the patient’s or user’s body, and special attention must be given to nanomaterials.

Infection and microbial contamination

11.(1) Devices and their manufacturing processes must be designed in such a way as to eliminate or to reduce as far as possible the risk of infection to patients, users and, where applicable, other persons and the design must—

(a)reduce as far as possible and appropriate the risks from unintended cuts and pricks, such as needle stick injuries;

(b)allow easy and safe handling;

(c)reduce as far as possible any microbial leakage from the device or microbial exposure during use;

(d)prevent microbial contamination of the device or its content such as specimens or fluids.

(2) Where necessary devices must be designed to facilitate their safe cleaning, disinfection or re-sterilisation.

(3) Devices labelled as having a specific microbial state must be designed, manufactured and packaged to ensure that they remain in that state when placed on the market and remain so under the transport and storage conditions specified by the manufacturer.

(4) Devices delivered in a sterile state must—

(a)be designed, manufactured and packaged in accordance with appropriate procedures, to ensure that they are sterile when placed on the market and that, unless the packaging which is intended to maintain their sterile condition is damaged, they remain sterile, under the transport and storage conditions specified by the manufacturer, until that packaging is opened at the point of use;

(b)ensure that the integrity of the packaging is clearly evident to the final user.

(5) Devices labelled as sterile must be processed, manufactured, packaged and, sterilised by means of appropriate, validated methods.

(6) Devices intended to be sterilised must be manufactured and packaged in appropriate and controlled conditions and facilities.

(7) Packaging systems for non-sterile devices must—

(a)maintain the integrity and cleanliness of the product;

(b)where the devices are to be sterilised prior to use, minimise the risk of microbial contamination;

(c)be suitable taking account of the method of sterilisation indicated by the manufacturer.

(8) The labelling of the device must distinguish between identical or similar devices placed on the market in both a sterile and a non-sterile condition in addition to the symbol used to indicate that devices are sterile.

Devices incorporating a substance considered to be a medicinal product and device that are composed of substances that are absorbed by or locally dispersed in the human body

12.(1) In the case of devices referred to in regulation 68(8), the quality, safety and usefulness of the substance which, if used separately, would be considered to be a medicinal product within the meaning of regulation 2 of the Human Medicines Regulations 2002, must be verified by analogy with the methods specified in Annex I to Directive 2001/83/EC read subject to modifications made by the Human Medicines Regulations 2012, as required by the applicable conformity assessment procedure under Part VIII.

(2) Devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body, and that are absorbed by or locally dispersed in the human body must comply, where applicable and in a manner limited to the aspects not covered by Part VIII, with the relevant requirements laid down in Annex I to Directive 2001/83/EC read subject to the modifications made by the Human Medicines Regulations 2012 for the evaluation of absorption, distribution, metabolism, excretion, local tolerance, toxicity, interaction with other devices, medicinal products or other substances and potential for adverse reactions, as required by the applicable conformity assessment procedure under Part VIII.

Devices incorporating materials of biological origin

13.(1) For devices manufactured utilising derivatives of tissues or cells of human origin which are non-viable or are rendered non-viable which are covered by Part VIII in accordance with regulation 68(6)(g), the following apply—

(a)donation, procurement and testing of the tissues and cells must be done in accordance with Human Tissue (Quality and Safety for Human Application) Regulations 2007;

(b)processing, preservation and any other handling of those tissues and cells or their derivatives must be carried out so as to provide safety for patients, users and, where applicable, other persons and, in particular, safety with regard to viruses and other transmissible agents must be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process;

(c)the traceability system for those devices must be complementary and compatible with the traceability and data protection requirements laid down in Human Tissue (Quality and Safety for Human Application) Regulations 2007 and in the Blood Safety and Quality Regulations 2005.

(2) For devices manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable the following apply—

(a)where feasible taking into account the animal species, tissues and cells of animal origin, or their derivatives, the tissues or cells must originate from animals that have been subjected to veterinary controls that are adapted to the intended use of the tissues and information on the geographical origin of those animals must be retained by manufacturers;

(b)sourcing, processing, preservation, testing and handling of tissues, cells and substances of animal origin, or their derivatives, must be carried out so as to provide safety for patients, users and, where applicable, other persons;

(c)safety with regard to viruses and other transmissible agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process, except when the use of such methods would lead to unacceptable degradation compromising the clinical benefit of the device;

(d)in the case of devices manufactured utilising tissues or cells of animal origin, or their derivatives, as referred to in the Regulation (EU) No 722/2012 the particular requirements laid down in that Regulation shall apply.

(3) For devices manufactured utilising non-viable biological substances other than those referred to in sub-paragraphs (1) and (2), the processing, preservation, testing and handling of those substances must be carried out so as to provide safety for patients, users and, where applicable, other persons, including in the waste disposal chain and, safety with regard to viruses and other transmissible agents, must be addressed by appropriate methods of sourcing and by implementation of validated methods of elimination or inactivation in the course of the manufacturing process.

Construction of devices and interaction with the environment

14.(1) If the device is intended for use in combination with other devices or equipment—

(a)the whole combination, including the connection system must be safe and must not impair the specified performance of the devices;

(b)any restrictions on use applying to such combinations must be indicated on the label or in the instructions for use;

(c)connections which the user has to handle, such as fluid, gas transfer, electrical or mechanical coupling, must be designed and constructed in such a way as to minimise all possible risks, such as misconnection.

(2) Devices must be designed and manufactured in such a way as to remove or reduce as far as possible—

(a)the risk of injury, in connection with their physical features, including the volume or pressure ratio, dimensional and where appropriate ergonomic features;

(b)risks connected with reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in pressure and acceleration or radio signal interferences;

(c)the risks associated with the use of the device when it comes into contact with materials, liquids, and substances, including gases, to which it is exposed during normal conditions of use;

(d)the risks associated with the possible negative interaction between software and the information technology environment within which it operates and interacts;

(e)the risks of accidental ingress of substances into the device;

(f)the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given;

(g)risks arising where maintenance or calibration are not possible (as with implants), from ageing of materials used or loss of accuracy of any measuring or control mechanism.

(3) Devices must be designed and manufactured in such a way as to minimise the risks of fire or explosion during normal use and in single fault condition and particular attention must be paid to devices the intended use of which includes exposure to or use in association with flammable or explosive substances or substances which could cause combustion.

(4) Devices must be designed and manufactured in such a way that adjustment, calibration and maintenance can be done safely and effectively.

(5) Devices that are intended to be operate together with other devices or products must be designed and manufactured in such a way that the interoperability and compatibility are reliable and safe.

(6) Any measurement, monitoring or display scale must be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used.

(7) In relation to the safe disposal of devices and related waste substances—

(a)devices must be designed and manufactured in such a way as to facilitate their safe disposal and the safe disposal of related waste substances by the user, patient or other person;

(b)manufacturers must identify and test procedures and measures as a result of which their devices can be safely disposed after use and such procedures must be described in the instructions for use.

Devices with a diagnostic or measuring function

15.(1) Diagnostic devices and devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy, precision and stability for their intended purpose, based on appropriate scientific and technical methods and the limits of accuracy shall be indicated by the manufacturer.

(2) The measurements made by devices with a measuring function shall be expressed in legal units conforming to the provisions of Units of Measurement Regulations 1986(74).

Protection against radiation

16.(1) Devices must be designed, manufactured and packaged in such a way that exposure of patients, users and other persons to radiation is reduced as far as possible, and in a manner that is compatible with the intended purpose, whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes.

(2) The operating instructions for devices emitting hazardous or potentially hazardous radiation must contain—

(a)detailed information as to—

(i)the nature of the emitted radiation, the means of protecting the patient and the user, and;

(ii)on ways of avoiding misuse and of reducing the risks inherent to installation as far as possible and appropriate;

(b)information regarding the acceptance and performance testing, the acceptance criteria, and the maintenance procedure.

(3) Devices which are designed to emit hazardous, or potentially hazardous, levels of ionizing or non-ionizing radiation necessary for a specific medical purpose, the benefit of which is considered to outweigh the risks inherent to the emission, must—

(a)make it possible for the user to control the emissions;

(b)must be designed and manufactured to ensure reproducibility of relevant variable parameters within an acceptable tolerance;

(c)be fitted, where possible, with visual displays or audible warnings of those emissions;

(d)be designed and manufactured in such a way that exposure of patients, users and other persons to the emission of unintended, stray or scattered radiation is reduced as far as possible;

(e)where possible and appropriate, ensure that methods are selected which reduce the exposure to radiation of patients, users and other persons who may be affected.

(4) Devices intended to emit ionizing radiation must—

(a)be designed and manufactured taking into account the requirements of any retained EU law which transposed Directive 2013/59/Euratom laying down basic safety standards for protection against the dangers arising from exposure to ionising radiation;

(b)be designed and manufactured in such a way as to ensure that, where possible, taking into account the intended use, the quantity, geometry and quality of the radiation emitted can be varied and controlled, and, if possible, monitored during treatment;

(c)where the device is intended for diagnostic radiology, be designed and manufactured in such a way as to achieve an image or output quality that is appropriate to the intended medical purpose whilst minimising radiation exposure of the patient and user;

(d)where the device is intended for therapeutic radiology, be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose, the beam type, energy and, where appropriate, the quality of radiation.

Electronic programmable systems — devices that incorporate electronic programmable systems and software that are devices in themselves

17.(1) Devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, must—

(a)be designed to ensure repeatability, reliability and performance in line with their intended use;

(b)in the event of a single fault condition, be designed with appropriate means to eliminate or reduce as far as possible consequent risks or impairment of performance.

(2) For devices that incorporate software or for software that are devices in themselves, the software must be developed and manufactured in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation.

(3) Software referred to in this paragraph that is intended to be used in combination with mobile computing platforms must be designed and manufactured taking into account the specific features of the mobile platform (for example size and contrast ratio of the screen) and the external factors related to their use (varying environment as regards level of light or noise).

(4) Manufacturers must set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorised access, necessary to run the software as intended.

Active devices and devices connected to them

18.(1) For non-implantable active devices, in the event of a single fault condition, appropriate means must be adopted to eliminate or reduce as far as possible consequent risks.

(2) Devices, where the safety of the patient depends on an internal power supply, must be equipped with—

(a)a means of determining the state of the power supply;

(b)an appropriate warning or indication for when the capacity of the power supply becomes critical, if necessary, such warning or indication must be given prior to the power supply becoming critical.

(3) Devices where the safety of the patient depends on an external power supply must include an alarm system to signal any power failure.

(4) Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient’s state of health.

(5) Devices must be designed and manufactured in such a way as to reduce as far as possible the risks of creating electromagnetic interference which could impair the operation of the device in question or other devices or equipment in the intended environment.

(6) Devices must be designed and manufactured in such a way as to provide a level of intrinsic immunity to electromagnetic interference that is adequate to enable them to operate as intended.

(7) Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of accidental electric shocks to the patient, user or any other person, both during normal use of the device and in the event of a single fault condition in the device, provided the device is installed and maintained as indicated by the manufacturer.

(8) Devices must be designed and manufactured in such a way as to protect, as far as possible, against unauthorised access that could hamper the device from functioning as intended.

Particular requirements for active implantable devices

19.(1) Active implantable devices must be designed and manufactured in such a way as to remove or minimize as far as possible—

(a)risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices;

(b)risks connected with medical treatment, in particular those resulting from the use of defibrillators or high- frequency surgical equipment;

(c)risks which may arise where maintenance and calibration are impossible, including—

(i)excessive increase of leakage currents;

(ii)ageing of the materials used;

(iii)excess heat generated by the device;

(iv)decreased accuracy of any measuring or control mechanism.

(2) Active implantable devices must be designed and manufactured in such a way as to ensure—

(a)if applicable, the compatibility of the devices with the substances they are intended to administer;

(b)the reliability of the source of energy.

(3) Active implantable devices and, if appropriate, their component parts must be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.

(4) Active implantable devices must bear a code—

(a)by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); and

(b)which it is possible to read, if necessary, without the need for a surgical operation.

Protection against mechanical and thermal risks

20.(1) Devices must be designed and manufactured in such a way as to protect patients and users against mechanical risks connected with, for example, resistance to movement, instability and moving parts.

(2) Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from vibration generated by the devices, taking account of technical progress and of the means available for limiting vibrations, particularly at source, unless the vibrations are part of the specified performance.

(3) Devices must be designed and manufactured in such a way as to reduce to the lowest possible level the risks arising from the noise emitted, taking account of technical progress and of the means available to reduce noise, particularly at source, unless the noise emitted is part of the specified performance.

(4) Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies which the user or other person has to handle, must be designed and constructed in such a way as to minimise all possible risks.

(5) Errors likely to be made when fitting or refitting certain parts which could be a source of risk —

(a)must be made impossible by the design and construction of such parts or by information given on the parts themselves or their housings; and

(b)must contain the same information on moving parts or their housings where the direction of movement needs to be known in order to avoid a risk.

(6) Accessible parts of devices (excluding the parts or areas intended to supply heat or reach given temperatures) and their surroundings must not attain potentially dangerous temperatures under normal conditions of use.

Protection against the risks posed to the patient or user by devices supplying energy or substances

21.(1) Devices for supplying the patient with energy or substances must be designed and constructed in such a way that the amount to be delivered can be set and maintained accurately enough to ensure the safety of the patient and of the user.

(2) Devices must—

(a)be fitted with the means of preventing or indicating any inadequacies in the amount of energy delivered or substances delivered which could pose a danger;

(b)incorporate suitable means to prevent, as far as possible, the accidental release of dangerous levels of energy or substances from an energy and/or substance source.

(3) The function of the controls and indicators—

(a)must be clearly specified on devices;

(b)where a device bears instructions required for its operation or indicates operating or adjustment parameters by means of a visual system, such information must be understandable to the user and, as appropriate, the patient.

Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons

22.(1) Devices for use by lay persons must—

(a)be designed and manufactured in such a way that they perform appropriately for their intended purpose taking into account the skills and the means available to lay persons and the influence resulting from variation that can be reasonably anticipated in the lay person’s technique and environment; and

(b)be provided by the manufacturer with information and instructions which are easy for the lay person to understand and apply.

(2) Devices for use by lay persons must be designed and manufactured in such a way as to—

(a)ensure that the device can be used safely and accurately by the intended user at all stages of the procedure, if necessary after appropriate training or information;

(b)reduce, as far as possible and appropriate, the risk from unintended cuts and pricks such as needle stick injuries; and

(c)reduce as far as possible the risk of error by the intended user in the handling of the device and, if applicable, in the interpretation of the results.

(3) Devices for use by lay persons must, where appropriate, include a procedure by which the lay person—

(a)can verify that, at the time of use, the device will perform as intended by the manufacturer;

(b)is warned if the device has failed to provide a valid result.

PART 3Requirements regarding instructions for use

Label and instructions for use

23.(1) Each device must be accompanied by the information (which may appear on the device itself, on the packaging or in the instructions for use) needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate.

(2) The information in paragraph (1) must, if the manufacturer has a website, be made available and kept up to date on the website.

(3) The label and instructions for use must take into account the following—

(a)that the medium, format, content, legibility, and location of the label and instructions for use must be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended users and, in particular, instructions for use must be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams;

(b)the information required on the label must be provided on the device itself or, if this is not practicable or appropriate, some or all of the information may appear on the packaging for each unit, or on the packaging of multiple devices;

(c)labels must be provided in a human-readable format and may be supplemented by machine-readable information, such as radio-frequency identification (‘RFID’) or bar codes;

(d)in general, instructions for use must be provided together with devices but, by way of exception, instructions for use are not required for Class I and Class IIa devices if such devices can be used safely without any such instructions and unless otherwise provided for elsewhere in this paragraph;

(e)where multiple devices are supplied to a single user or location, a single copy of the instructions for use may be provided if so agreed by the purchaser who in any case may request further copies to be provided free of charge;

(f)instructions for use may be provided to the user in non-paper format (for example electronic) to the extent, and only under the conditions, set out in Regulation (EU) No 207/2012;

(g)residual risks which are required to be communicated to the user or other person must be included as limitations, contra-indications, precautions or warnings in the information supplied by the manufacturer;

(h)where appropriate, the information supplied by the manufacturer —

(i)must take the form of internationally recognised symbols;

(ii)must conform, in terms of any symbol or identification colour used, to the relevant standards; and

(iii)in areas for which no relevant standards exist, the symbols and colours must be described in the documentation supplied with the device.

Information on the label

(4) The label must bear the following particulars—

(a)the name or trade name of the device;

(b)the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;

(c)the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;

(d)if the manufacturer has its registered place of business outside the United Kingdom, the name and address of the person placing the device on the market;

(e)where applicable, an indication that the device contains or incorporates—

(i)a medicinal substance, including a human blood or plasma derivative, or tissues or cells, or their derivatives, of human origin; or

(ii)tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012;

(f)where applicable, information labelled in accordance with paragraph 10(10);

(g)the lot number or the serial number of the device preceded by the words LOT NUMBER or SERIAL NUMBER or an equivalent symbol, as appropriate;

(h)the UDI carrier referred to in regulation 91(4) and Part C of Schedule 8;

(i)an unambiguous indication of the time limit for using or implanting the device safely, expressed at least in terms of year and month, where this is relevant;

(j)where there is no indication of the date until when it may be used safely, the date of manufacture and this date of manufacture may be included as part of the lot number or serial number, provided the date is clearly identifiable;

(k)an indication of any special storage or handling condition that applies;

(l)if the device is supplied sterile, an indication of its sterile state and the sterilisation method;

(m)warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person (this information may be kept to a minimum in which case, more detailed information must appear in the instructions for use, taking into account the intended users);

(n)if the device is intended for single use, an indication of that fact;

(o)if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles;

(p)if the device is custom-made, the words ‘custom-made device’;

(q)an indication that the device is a medical device and, if the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’;

(r)in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action;

(s)for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.

(5) Where packaging maintains the sterile condition of the device (“sterile packaging”) the following particulars must appear on that sterile packaging—

(a)an indication permitting the sterile packaging to be recognised as such;

(b)a declaration that the device is in a sterile condition;

(c)the method of sterilisation;

(d)the name and address of the manufacturer;

(e)a description of the device;

(f)if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’;

(g)if the device is custom-made, the words ‘custom-made device’;

(h)the month and year of manufacture;

(i)an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month;

(j)an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use.

Information in instructions for use

(6) The instructions for use must contain all the following particulars—

(a)the particulars referred to in paragraphs (a), (c), (e), (f), (k), (l), (n) and (r) of paragraph 23(4);

(b)the device’s intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate;

(c)where applicable, a specification of the clinical benefits to be expected;

(d)where applicable, links to the summary of safety and clinical performance referred to in regulation 96;

(e)the performance characteristics of the device;

(f)where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories;

(g)any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard;

(h)specifications the user requires to use the device appropriately, for example if the device has a measuring function, the degree of accuracy claimed for it;

(i)details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection;

(j)any requirements for special facilities, or special training, or particular qualifications of the device user or other persons;

(k)the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant—

(i)details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection;

(ii)identification of any consumable components and how to replace them;

(iii)information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime;

(iv)methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices;

(l)if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;

(m)if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation;

(n)if the device is reusable, information must be provided—

(i)on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation; and

(ii)to identify when the device should no longer be reused, for example signs of material degradation or the maximum number of allowable reuses;

(o)an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements;

(p)if the device bears an indication that it is for single use—

(i)information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used;

(ii)the information must be based on a specific section of the manufacturer’s risk management documentation, where such characteristics and technical factors must be addressed in detail;

(iii)if, in accordance with sub-paragraph (3)(d), no instructions for use are required, this information must be made available to the user upon request;

(q)for devices intended for use together with other devices or general purpose equipment—

(i)information to identify such devices or equipment, in order to obtain a safe combination;

(ii)information on any known restrictions to combinations of devices and equipment;

(r)if the device emits radiation for medical purposes—

(i)detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation;

(ii)the means of protecting the patient, user, or other person from unintended radiation during use of the device;

(s)information that allows the user or patient to be informed of, or as the case may be, briefed about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device and this information must cover, where appropriate—

(i)warnings, precautions or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety;

(ii)warnings, precautions or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature;

(iii)warnings, precautions or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment;

(iv)if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered;

(v)warnings, precautions or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and

(vi)precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user;

(t)in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body and that are absorbed by or locally dispersed in the human body, warnings and precautions, where appropriate, related to—

(i)the general profile of interaction of the device and its products of metabolism with other devices, medicinal products and other substances;

(ii)contra-indications, undesirable side-effects and risks relating to overdose;

(u)in the case of implantable devices, the overall qualitative and quantitative information on the materials and substances to which patients can be exposed;

(v)warnings or precautions to be taken in order to facilitate the safe disposal of the device, its accessories and the consumables used with it, which must, where appropriate cover—

(i)infection or microbial hazards such as explants, needles or surgical equipment contaminated with potentially infectious substances of human origin, and

(ii)physical hazards such as from sharps;

(iii)if, in accordance with the sub-paragraph (3)(d), no instructions for use are required, this information must be made available to the user upon request;

(w)for devices intended for use by lay persons, the circumstances in which the user should consult a healthcare professional;

(x)for the devices covered by Part VIII of these Regulations pursuant to regulation 68(2)(b), information regarding the absence of a clinical benefit and the risks related to use of the device;

(y)the date of issue of the instructions for use or, if they have been revised, the date of issue and the identifier of the latest revision of the instructions for use;

(z)a notice to the user or patient that any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the Secretary of State;

(aa)information to be supplied to the patient with an implanted device in accordance with regulation 83;

(bb)for devices that incorporate electronic programmable systems, including software, or software that are devices in themselves, minimum requirements concerning hardware, Information Technology networks characteristics and Information Technology security measures, including protection against unauthorised access, necessary to run the software as intended.

Regulation 1A

SCHEDULE 4Technical Documentation

1.  The technical documentation and, if applicable, the summary of that documentation drawn up by the manufacturer must be presented in clear, organised, readily searchable and unambiguous manner and must include the elements listed in this Schedule.

Device description and specification including variants and accessories

Device description and specification

2.(1) The description and specification of a device must contain the following—

(a)the product or trade name and a general description of the device including its intended purpose and intended users;

(b)the Basic UDI-DI as referred to in Part C of Schedule 8 assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;

(c)the intended patient population and medical conditions to be diagnosed, treated or monitored and other considerations such as patient selection criteria, indications, contra-indications, warnings;

(d)principles of operation of the device and its mode of action, scientifically demonstrated if necessary;

(e)the rationale for the qualification of the product as a device;

(f)the risk class of the device and the justification for the classification rules applied in accordance with Schedule 9;

(g)an explanation of any novel features;

(h)a description of the accessories for the device, other devices and other products that are not devices, which are intended to be used in combination with it;

(i)a description or complete list of the various configurations or variants of the device that are intended to be made available on the market;

(j)a general description—

(i)of the key functional elements, for example its parts or components (including software if appropriate), its formulation, its composition, its functionality and, where relevant, its qualitative and quantitative composition; and

(ii)which, where appropriate, must include labelled pictorial representations (for example diagrams, photographs, and drawings), clearly indicating key parts or components, including sufficient explanation to understand the drawings and diagrams;

(k)a description of the raw materials incorporated into key functional elements and those making either direct contact with the human body or indirect contact with the body, for example during extracorporeal circulation of body fluids;

(l)technical specifications, such as features, dimensions and performance attributes, of the device and any variants or configurations and accessories that would typically appear in the product specification made available to the user, for example in brochures, catalogues and similar publications.

Reference to previous and similar generations of the device

(2) Where applicable the technical documentation must contain—

(a)an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;

(b)an overview of identified similar devices available on the international markets, where such devices exist.

Information to be supplied by the manufacturer

3.  The manufacturer must supply a complete set of—

(a)the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions in English; and

(b)the instructions for use in English.

Design and manufacturing information

4.  The following design and manufacturing information must be supplied—

(a)information (including full data) to allow the design stages applied to the device to be understood;

(b)complete information (including full data) and specifications, including the manufacturing processes and their validation, their adjuvants, the continuous monitoring and the final product testing.

General safety and performance requirements

5.(1) The documentation must contain information for the demonstration of conformity with the general safety and performance requirements set out in Schedule 3 that are applicable to the device taking into account its intended purpose, and must include a justification, validation and verification of the solutions adopted to meet those requirements.

(2) The demonstration of conformity in sub-paragraph (1) must include—

(a)the general safety and performance requirements that apply to the device and an explanation as to why others do not apply;

(b)the method or methods used to demonstrate conformity with each applicable general safety and performance requirement;

(c)the standards or other solutions applied;

(d)the precise identity of the controlled documents offering evidence of conformity with each standard, or other method applied to demonstrate conformity with the general safety and performance requirements; and

(e)the information referred to paragraph (d) must incorporate a cross-reference to the location of such evidence within the full technical documentation and, if applicable, the summary technical documentation.

Benefit-risk analysis and risk management

6.  The technical documentation must contain information on—

(a)the benefit-risk analysis referred to in paragraphs 1 and 8 of Schedule 3;

(b)the solutions adopted and the results of the risk management referred to in paragraph 3 of Schedule 3.

Product verification and validation

7.(1) The documentation must contain the results and critical analyses of all verifications and validation tests or studies undertaken to demonstrate conformity of the device with the requirements of Part VIII and in particular the applicable general safety and performance requirements.

Pre-clinical and clinical data.

(2) The documentation must contain the following pre-clinical and clinical data—

(a)results of tests, such as engineering, laboratory, simulated use and animal tests, and evaluation of published literature applicable to the device, taking into account its intended purpose, or to similar devices, regarding the pre-clinical safety of the device and its conformity with the specifications;

(b)detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions regarding in particular—

(i)the biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user;

(ii)physical, chemical and microbiological characterisation;

(iii)electrical safety and electromagnetic compatibility;

(iv)software verification and validation which must—

(aa)describe the software design and development process and provide evidence of the validation of the software, as used in the finished device;

(bb)typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or actual user environment prior to final release; and

(cc)address all of the different hardware configurations and, where applicable, operating systems identified in the information supplied by the manufacturer;

(v)stability, including shelf life; and

(vi)performance and safety.

(3) Where applicable, conformity with the Good Laboratory Practice Regulations 1999(75) must be demonstrated.

(4) Where no new testing has been undertaken, the documentation must incorporate a rationale for that decision (for example, a rationale would be that biocompatibility testing on identical materials was conducted when those materials were incorporated in a previous version of the device that has been legally placed on the market or put into service).

(5) The documentation must also include—

(a)the clinical evaluation report and its updates and the clinical evaluation plan referred to in regulation 102(14) and Part A of Schedule 14;

(b)the PMCF plan and PMCF evaluation report referred to in Part B of Schedule 14 or a justification why a PMCF is not applicable.

Additional information required in specific cases

(6) The additional information specified is required as part of the technical documentation in the following cases—