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;
- a
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;
- a
“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
- i
- b
in relation to other medical devices, the Secretary of State;
- a
“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;
- a
“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
F3the EU Medical Devices Regulations;
- a
“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;
- a
F2“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);
- a
“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).