PART 4Medical devices

CHAPTER 5Interpretation of Part 4

42Interpretation of Part 4

(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—

  1. (i)

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

  2. (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).