PART 4

Medical devices
CHAPTER 5

Interpretation of Part 4

Interpretation of Part 4
42
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—
  1. in England and Wales, the Crown Court;
  2. in Scotland, the Sheriff Appeal Court;
  3. in Northern Ireland, a county court;
- the “appropriate lower court” means—
  1. in England and Wales, a magistrates' court;
  2. in Scotland, the sheriff;
  3. 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—
  1. in relation to medical devices which are ordinarily intended for private use or consumption—
    1. a local weights and measures authority in Great Britain or a district council in Northern Ireland, or
    2. the Secretary of State, or
  2. in relation to other medical devices, the Secretary of State;
- “EU Medical Devices Regulations” means—
  1. 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
  2. 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;
- “manufacturer” means any person who is a manufacturer for the purposes of any provision in—
  1. the Medical Devices Regulations 2002 (
S.I. 2002/618
), or
  2. the EU Medical Devices Regulations;
- “
medical device
” includes—
  1. medical devices to which the Medical Devices Regulations 2002 apply, and
  2. devices to which the EU Medical Devices Regulations apply;
- “medical devices provision”—
  1. in Chapter 1, has the meaning given by section 17(2), and
  2. 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).
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)
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)
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