Medicines and Medical Devices Act 2021

CHAPTER 5U.K.Interpretation of Part 4

42Interpretation of Part 4U.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)

    [F2the 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