Medicines and Medical Devices Act 2021

42Interpretation of Part 4U.K.

This section has no associated Explanatory Notes

(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