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

http://www.legislation.gov.uk/uksi/2002/618/regulation/23/2002-06-13

The Medical Devices Regulations 2002

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Statute Law Database

CONSUMER PROTECTION

2024-05-16

2002-06-13

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 IIIActive Implantable Medical Devices

Determining compliance of active implantable medical devices with relevant essential requirements23

1

In determining which are the relevant essential requirements for a particular relevant device, and whether or not it complies with any of the relevant essential requirements, account shall be taken of its intended purpose.

2

Any—

a

determination that a relevant device complies with any of the essential requirements set out in paragraphs 1 to 5 of Annex 1; and

b

evaluation of side effects or undesirable effects for the purposes of determining whether or not a relevant device complies with any of the essential requirements,

shall be based in particular on clinical data, the adequacy of which is based on the collation of scientific literature or the results of clinical investigations referred to in paragraph 1 of Annex 7, and any determination as to whether or not a relevant device complies with any other essential requirements may be based on such data.

3

In the case of a relevant device which is being or has been put into service—

a

the essential requirements specified in paragraph 14 of Annex 1 are complied with only if the particulars there specified are in English (whether or not they are also in another language and whether or not the device is for professional use); and

b

the essential requirements specified in paragraph 13 of Annex 1, so far as they relate to instructions required for the operation of a device in paragraph 15 of Annex 1, are complied with only if—

i

the instructions are in English or another Community language, and

ii

if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.

4

A relevant device shall be treated as complying with an essential requirement if it conforms as respects that requirement to a relevant national Standard, unless there are reasonable grounds for suspecting that the device does not comply with that requirement.

5

A custom-made device in respect of which the conditions specified in Annex 6 are satisfied and which is accompanied by the statement referred to in paragraph 1 of Annex 6 shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.

6

A device intended for clinical investigation in respect of which—

a

the conditions specified in Annex 7 are satisfied;

b

notice has been given under regulation 29(1); and

c

either—

i

no notice has been given under regulation 29(3) within the period of 60 days there referred to, or

ii

notice has been given under regulation 29(4),

shall be taken to comply with the relevant essential requirements unless there are reasonable grounds for suspecting that the device does not comply with those requirements.