http://www.legislation.gov.uk/uksi/2002/618/regulation/1
The Medical Devices Regulations 2002
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Statute Law Database
CONSUMER PROTECTION
2024-05-16
Expert Participation
2024-03-21
These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93/42/EEC concerning medical devices, as amended; and Directive 98/79/EC of the European Parliament and of the Council onin vitro diagnostic medical devices (“the Medical Devices Directives”). They also contain the legislative measures necessary for the implementation, in relation to medical devices, of the agreements on mutual recognition between the European Community and Australia, New Zealand, Canada and the United States of America—and of the Association Agreement between the European Communities, and their Member States, and Hungary.
The Medical Devices Regulations 2002
Pt. 8
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
reg. 10
reg. 1(1)
The Medical Devices Regulations 2002
Pt. 9
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
reg. 11
reg. 1(1)
The Medical Devices Regulations 2002
reg. 4D(10)(b)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 2(3)(a)
reg. 1
The Medical Devices Regulations 2002
reg. 4E(7)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 2(3)(b)
reg. 1
The Medical Devices Regulations 2002
reg. 6(d)
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
reg. 4(2)
reg. 1(1)
The Medical Devices Regulations 2002
reg. 33(1)(c)
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
reg. 6(2)(a)
reg. 1(1)
The Medical Devices Regulations 2002
reg. 33(2)(c)
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
reg. 6(2)(b)
reg. 1(1)
The Medical Devices Regulations 2002
reg. 75(3)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 9(2)(a)
reg. 1
The Medical Devices Regulations 2002
reg. 75(7)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 9(2)(b)
reg. 1
The Medical Devices Regulations 2002
reg. 93(4)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 9(3)
reg. 1
The Medical Devices Regulations 2002
reg. 119(6)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 9(4)
reg. 1
The Medical Devices Regulations 2002
reg. 124(5)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 9(5)
reg. 1
The Medical Devices Regulations 2002
reg. 149(5)(e)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 10(2)
reg. 1
The Medical Devices Regulations 2002
reg. 158(1)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 10(3)(a)
reg. 1
The Medical Devices Regulations 2002
reg. 158(3)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 10(3)(b)
reg. 1
The Medical Devices Regulations 2002
Sch. 19
para. 5
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 11(2)(a)
reg. 1
The Medical Devices Regulations 2002
Sch. 19
para. 5
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 11(2)(b)
reg. 1
The Medical Devices Regulations 2002
Sch. 24 para. 1(7) heading
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 11(3)(a)
reg. 1
The Medical Devices Regulations 2002
Sch. 24
para. 1(7)
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019
Sch. 2
para. 11(3)(b)
reg. 1
The Medical Devices Regulations 2002
reg. 60A-60C
Medicines and Medical Devices Act 2021
Sch. 3
para. 1
s. 50(3)
The Medical Devices Regulations 2002
reg. 60A
Medicines and Medical Devices Act 2021
Sch. 2
para. 4
s. 50(3)
The Medical Devices Regulations 2002
reg. 60A
Medicines and Medical Devices Act 2021
Sch. 2
para. 5(2)
s. 50(3)
The Medical Devices Regulations 2002
Sch. 3
Medicines and Medical Devices Act 2021
Sch. 3
para. 2
s. 50(3)
PART IIntroductory Provisions Relating to all Medical Devices
Citation and commencement1
These Regulations may be cited as the Medical Devices Regulations 2002 and shall come into force 13th June 2002.