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

http://www.legislation.gov.uk/uksi/2002/618/regulation/48/2023-07-01

The Medical Devices Regulations 2002

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text/xml

Statute Law Database

CONSUMER PROTECTION

2024-05-16

Expert Participation

2023-07-01

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. 48 heading

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(a)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(b)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48 heading

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(1)

The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

reg. 7(4)(c)

reg. 1(1)

The Medical Devices Regulations 2002

reg. 48(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(1)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(2)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(2)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(4)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(5)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(5)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(6)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(7)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(8)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 1

The Medical Devices Regulations 2002

reg. 48(8)

The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Sch. 2

para. 6(2)

reg. 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 VF23Notified BodiesF23Approved Bodies, Conformity Assessment Bodies and Marking of Products

Annotations:

Amendments (Textual)

F23

Words in Pt. 5 heading substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(2) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47); 2020 c. 1, Sch. 5 para. 1(1)

Designation etc. of F18... conformity assessment bodiesE248

1

The Secretary of State may designate for the purposes of F12a mutual recognition agreement any corporate or other body as a body which is to carry out any of the tasks of a F6... conformity assessment body, and, if he so designates a body (referred to in these Regulations as F22a “CAB”), he shall designate the tasks which it is to carry out.

2

A body may be designated under paragraph (1) as a body which is to carry out tasks of F2a CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of F2a CAB arising out of F7a mutual recognition agreement which it needs to be able to fulfil.

3

The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

4

The Secretary of State may vary the tasks that F20a CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

5

The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

a

the body so requests; or

b

he considers that the body is not capable of fulfilling the functions of F9a CAB arising out of F19a mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

6

Before—

a

effecting a variation under paragraph (4); or

b

restricting or withdrawing a designation under paragraph (5),

otherwise than at the F29... CAB’s request, the Secretary of State shall give to the F29... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

7

For the purpose of deciding whether or not a body is capable of fulfilling the functions of F15a CAB arising out of F8a mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

a

any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

b

any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

8

The Secretary of State may request that F3a CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of F3a CAB arising out of F16a mutual recognition agreement which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.

Designation etc. of F27... conformity assessment bodiesE148

1

The Secretary of State may designate for the purposes of F10a UK mutual recognition agreement any corporate or other body as a body which is to carry out any of the tasks of a F4... conformity assessment body, and, if he so designates a body (referred to in these Regulations as F11a “CAB”), he shall designate the tasks which it is to carry out.

2

A body may be designated under paragraph (1) as a body which is to carry out tasks of F14a CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of F14a CAB arising out of F26a UK mutual recognition agreement which it needs to be able to fulfil.

3

The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

4

The Secretary of State may vary the tasks that F13a CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

5

The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

a

the body so requests; or

b

he considers that the body is not capable of fulfilling the functions of F1a CAB arising out of F17a UK mutual recognition agreement which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

6

Before—

a

effecting a variation under paragraph (4); or

b

restricting or withdrawing a designation under paragraph (5),

otherwise than at the F5... CAB’s request, the Secretary of State shall give to the F5... CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

7

For the purpose of deciding whether or not a body is capable of fulfilling the functions of F24a CAB arising out of F21a UK mutual recognition agreement which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

a

any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

b

any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

8

The Secretary of State may request that F25a CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of F25a CAB arising out of F28a UK mutual recognition agreement which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.