http://www.legislation.gov.uk/id/uksi/2002/618

http://www.legislation.gov.uk/uksi/2002/618/regulation/39A/2021-07-28

The Medical Devices Regulations 2002

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Statute Law Database

CONSUMER PROTECTION

2024-05-16

Expert Participation

2021-07-28

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 IVIn Vitro Diagnostic Medical Devices

F1Exemptions for coronavirus test devices39A

1

Regulation 34A does not apply where, in circumstances which give rise to a need to protect the public from a risk of serious harm to health, the Secretary of State—

a

has decided to permit, where appropriate for a specified period, the placing on the market or putting into service of a particular coronavirus test device or coronavirus test devices of a particular class or description that has not been approved under regulation 38A(5); and

b

has not withdrawn that permission.

2

The Secretary of State may give permission under paragraph (1) subject to such conditions as are set out in a protocol published by the Secretary of State.

3

If the Secretary of State publishes a protocol for the purpose of paragraph (2), the protocol must specify the period of time for which it has effect.

4

The Secretary of State may withdraw or amend a protocol published under paragraph (2).