PART IV U.K.In Vitro Diagnostic Medical Devices

Interpretation of Part IV E+W+S

32.—(1) In this Part F1 ...—

• “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

  (a)

  itself an in vitro diagnostic medical device;

  (b)

  an invasive sampling medical device; or

  (c)

  a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

• “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

• [F2 “common technical specification” means a technical specification set out in the Annex to Commission Decision 2002/364/EC (as retained under section 3 of the European Union Withdrawal Act 2018 and modified under section 8 of that Act) for a relevant device referred to in a list in Annex II;]

• “device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and

• “relevant device” shall be construed in accordance with regulation 33(1);

(2) In this Part F1 ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F1 Words in reg. 32(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 11

F2 Words in reg. 32 substituted (E.W.S.) (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 1 para. 15

Interpretation of Part IV N.I.

32.—(1) In this Part F3 ...—

• “accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not—

  (a)

  itself an in vitro diagnostic medical device;

  (b)

  an invasive sampling medical device; or

  (c)

  a medical device which is directly applied to the human body for the purpose of obtaining a specimen;

• “calibration and control material” means any substance, material or article intended by its manufacturer either to establish measurement relationships or to verify the performance characteristics of a relevant device in conjunction with the intended use of that device;

• “common technical specification” means a technical specification for a relevant device referred to in a list in Annex II which has been adopted in accordance with the procedure set out in article 7(2) and published in the Official Journal of the [F4 European Union];

• “device for self-testing” means anin vitro diagnostic medical device which is intended by its manufacturer to be able to be used by a member of the public in a home environment; and

• “relevant device” shall be construed in accordance with regulation 33(1);

(2) In this Part F3 ..., a reference to a numbered article or Annex is to the article or Annex of Directive 98/79 bearing that number.

Extent Information

E2 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Textual Amendments

F3 Words in reg. 32(1)(2) omitted (1.9.2003) by virtue of The Medical Devices (Amendment) Regulations 2003 (S.I. 2003/1697), regs. 1(1)(a), 11

F4 Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3))