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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART VI
- Regulation 56
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Changes over time for: Section 56
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Changes to legislation:
The Medical Devices Regulations 2002, Section 56 is up to date with all changes known to be in force on or before 26 April 2024. There are changes that may be brought into force at a future date. Changes that have been made appear in the content and are referenced with annotations.
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Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the legislation in the affected provisions. Use the ‘more’ link to open the changes and effects relevant to the provision you are viewing.
Changes and effects yet to be applied to Regulation 56:
- reg. 56(1)(a)(i) word substituted by S.I. 2007/610 reg. 13(4)(a)(i)
- reg. 56(1)(a)(ii) word substituted by S.I. 2007/610 reg. 13(4)(a)(ii)
- reg. 56(1)(b)(i) word substituted by S.I. 2007/610 reg. 13(4)(b)(i)
- reg. 56(1)(b)(ii) word substituted by S.I. 2007/610 reg. 13(4)(b)(ii)
Changes and effects yet to be applied to the whole Instrument associated Parts and Chapters:
Whole provisions yet to be inserted into this Instrument (including any effects on those provisions):
- Pt. 8 inserted by S.I. 2019/791 reg. 10 (This amendment not applied to legislation.gov.uk. Reg. 10 omitted immediately before IP completion day by virtue of S.I. 2020/1478, regs. 1(3), Sch. 2 para. 54)
- Pt. 9 inserted by S.I. 2019/791 reg. 11 (This amendment not applied to legislation.gov.uk. Reg. 11 omitted immediately before IP completion day by virtue of S.I. 2020/1478, regs. 1(3), Sch. 2 para. 55)
- Sch. 3 inserted by 2021 c. 3 Sch. 3 para. 2
- Sch. 19 para. 5 words substituted by S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(2)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- Sch. 19 para. 5 words substituted by S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(2)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- Sch. 24 para. 1(7) heading words omitted by virtue of S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- Sch. 24 para. 1(7) words omitted by virtue of S.I. 2019/791, reg. 12 (as amended) by S.I. 2019/1385 Sch. 2 para. 11(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 4D(10)(b) substituted by S.I. 2019/791, reg. 3(7) (as amended) by S.I. 2019/1385 Sch. 2 para. 2(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(a)(ii))
- reg. 4E(7) words substituted by S.I. 2019/791, reg. 3(7) (as amended) by S.I. 2019/1385 Sch. 2 para. 2(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 para. 2(3) omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(a)(ii))
- reg. 6(d) inserted by S.I. 2019/791 reg. 4(2) (This amendment not applied to legislation.gov.uk. Reg. 4(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 10)
- reg. 33(1)(c) inserted by S.I. 2019/791 reg. 6(2)(a) (This amendment not applied to legislation.gov.uk. Reg. 6(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 35)
- reg. 33(2)(c) inserted by S.I. 2019/791 reg. 6(2)(b) (This amendment not applied to legislation.gov.uk. Reg. 6(2) omitted immediately before IP completion day by S.I. 2020/1478, regs. 1(3), Sch. 2 para. 35)
- reg. 60A excluded by 2021 c. 3 Sch. 2 para. 4
- reg. 60A excluded by 2021 c. 3 Sch. 2 para. 5(2)
- reg. 60A-60C inserted by 2021 c. 3 Sch. 3 para. 1
- reg. 75(3) words inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(2)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 75(7) inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(2)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 93(4) inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(3) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 119(6) words inserted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(4) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 124(5) words substituted by S.I. 2019/791, reg. 10 (as amended) by S.I. 2019/1385 Sch. 2 para. 9(5) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 149(5)(e) words substituted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(2) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 158(1) substituted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(3)(a) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
- reg. 158(3) inserted by S.I. 2019/791, reg. 11 (as amended) by S.I. 2019/1385 Sch. 2 para. 10(3)(b) (This amendment not applied to legislation.gov.uk. Sch. 2 paras. 9-11 omitted (9.12.2020) by virtue of S.I. 2020/1478, regs. 1(2), 4(2)(c))
Fees payable in relation to clinical investigation noticesE+W+S
56.—(1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—
(a)if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—
(i)a fee, if the device is a Group A device, of [F1£5,711], or
(ii)a fee, if the device is a Group B device, of [F2£11,069]; or
(b)in all other cases—
(i)a fee, if the device is a Group A device, of [F3£7,472], or
(ii)a fee, if the device is a Group B device, of [F4£15,627].
(2) Except where paragraph (3) [F5or (3A)] applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or [F6their UK responsible person] has previously given such notice in relation to that device.
(3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—
(a)a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;
(b)a change to the number of patients or devices forming the basis of the proposed trial;
(c)a change or extension in the indications for use of the device or to the purpose or objectives of the trial;
(d)a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or
(e)a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.
[F7(3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—
(a)a fee, if the device is a Group A device, of £207; or
(b)a fee, if the device is a Group B device, of £331.]
[F8(3B) A person who requests a meeting with the Secretary of State in respect of an intended clinical investigation under regulation 16(1A) or 29(1A) must pay the following fees in advance of the meeting—
(a)£906 for a regulatory advice meeting under regulation 16(1A)(a) or 29(1A)(a); and
(b)£782 for a statistical review meeting under regulation 16(1A)(b) or 29(1A)(b).]
(4) A fee under this regulation—
(a)shall be payable when the notice to which it relates is given to the Secretary of State; and
(b)shall accompany that notice when it is given.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Sum in reg. 56(1)(a)(i) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 13(1)(a)
F2Sum in reg. 56(1)(a)(ii) substituted (E.W.S) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 13(1)(b)
F3Sum in reg. 56(1)(b)(i) substituted (E.W.S) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 13(1)(c)
F4Sum in reg. 56(1)(b)(ii) substituted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 13(1)(d)
F5Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2)
F6Words in reg. 56(2) substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 8(4A) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 49); 2020 c. 1, Sch. 5 para. 1(1)
F7Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3)
F8Reg. 56(3B) inserted (E.W.S.) (1.4.2023) by The Medical Devices and Blood Safety and Quality (Fees Amendment) Regulations 2023 (S.I. 2023/377), regs. 1(2), 13(2)
Fees payable in relation to clinical investigation noticesN.I.
56.—(1) Subject to paragraph (2), any person required to give the Secretary of State notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall, in respect of the consideration by the Secretary of State of the information that the person is required to submit, pay to the Secretary of State—
(a)if, as regards that device, it is the second or subsequent occasion on which the person has given the Secretary of State notice of an intended clinical investigation, and the changes from the immediately preceding notice are limited to addressing the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation—
(i)a fee, if the device is a Group A device, of [F9£2,920], or
(ii)a fee, if the device is a Group B device, of [F9£3,570]; or
(b)in all other cases—
(i)a fee, if the device is a Group A device, of [F10£3,820], or
(ii)a fee, if the device is a Group B device, of [F10£5,040].
(2) Except where paragraph (3) [F11or (3A)] applies, no fee shall be payable in respect of a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) where the manufacturer or his authorised representative has previously given such notice in relation to that device.
(3) A fee shall be payable where the investigational plan which forms part of the statement accompanying the notice differs from the plan submitted with the immediately preceding notice in that it includes—
(a)a change to address the grounds on which the Secretary of State has refused or withdrawn permission to hold a clinical investigation;
(b)a change to the number of patients or devices forming the basis of the proposed trial;
(c)a change or extension in the indications for use of the device or to the purpose or objectives of the trial;
(d)a change in any of the materials used in the device that come into direct contact with the human body if the new materials are not known to be biocompatible; or
(e)a change in the design of the device involving a novel feature not previously tested, being a change that has a direct effect on a vital physiological function.
[F12(3A) Any person who submits an amendment to a notice of the supply of a device for the purposes of a clinical investigation under regulation 16(1) or 29(1) shall pay to the Secretary of State—
(a)a fee, if the device is a Group A device, of £207; or
(b)a fee, if the device is a Group B device, of £331.]
(4) A fee under this regulation—
(a)shall be payable when the notice to which it relates is given to the Secretary of State; and
(b)shall accompany that notice when it is given.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F9Sums in reg. 56(1)(a) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(a)
F10Sums in reg. 56(1)(b) substituted (1.4.2013) by The Medical Devices (Fees Amendment) Regulations 2013 (S.I. 2013/525), regs. 1, 2(2)(b)
F11Words in reg. 56(2) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(2)
F12Reg. 56(3A) inserted (1.4.2017) by The Medical Devices (Fees Amendment) Regulations 2017 (S.I. 2017/207), regs. 1(1), 5(3)
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