Medicines and Medical Devices Act 2021 (c. 3)

PART 4 U.K. Medical devices

CHAPTER 5 U.K. Interpretation of Part 4

42 Interpretation of Part 4 U.K.

(1) In this Part, apart from in sections 32, 33 and 34 (provisions relating to forfeiture or seizure of medical devices), references to a medical device include references to a type of medical device.

(2) In this Part—

• the “appropriate appeals court” means—

  (a)

  in England and Wales, the Crown Court;

  (b)

  in Scotland, the Sheriff Appeal Court;

  (c)

  in Northern Ireland, a county court;

• the “appropriate lower court” means—

  (a)

  in England and Wales, a magistrates' court;

  (b)

  in Scotland, the sheriff;

  (c)

  in Northern Ireland, a court of summary jurisdiction;

• “compliance notice” has the meaning given by section 21(2);

• “data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;

• the “enforcement authority” means—

  (a)

  in relation to medical devices which are ordinarily intended for private use or consumption—

  (i)

  a local weights and measures authority in Great Britain or a district council in Northern Ireland, or

  (ii)

  the Secretary of State, or

  (b)

  in relation to other medical devices, the Secretary of State;

• “EU Medical Devices Regulations” means—

  (a)

  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, and

  (b)

  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;

• “forfeiture order” has the meaning given by section 32(1);

• “information notice” has the meaning given by section 24(2);

• “manufacture” includes assembly;

• [F1 “manufacturer” means any person who is a manufacturer for the purposes of any provision in—

  (a)

  the Medical Devices Regulations 2002 (S.I. 2002/618), or

  (b)

  [F2 the EU Medical Devices Regulations;]

• “medical device” includes—

  (a)

  medical devices to which the Medical Devices Regulations 2002 apply, and

  (b)

  devices to which the EU Medical Devices Regulations apply;

• [F3 “medical devices provision”—

  (a)

  in Chapter 1, has the meaning given by section 17(2), and

  (b)

  in Chapter 3, has the meaning given by section 21(1A);]

• “relevant requirements” has the meaning given by section 16(1)(a);

• “safety notice” has the meaning given by section 23(1);

• “suspension notice” has the meaning given by section 22(2).]

Textual Amendments

F1 Words in s. 42(2) substituted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 28(6)(a)

F2 Words in s. 42(2) substituted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 7

F3 Words in s. 42(2) substituted (27.7.2021) by The Medical Devices (Northern Ireland Protocol) Regulations 2021 (S.I. 2021/905), regs. 1(2), 28(6)(b)