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

http://www.legislation.gov.uk/uksi/2002/618/regulation/21A

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 IIIActive Implantable Medical Devices

F1Registration of persons placing active implantable medical devices on the market21A

1

No person may place a relevant device on the market in accordance with this Part unless that person—

a

is established in Great Britain; and

b

has complied with paragraph (2).

2

A person who places a relevant device on the market complies with this paragraph if, before placing the relevant device on the market—

a

where—

i

that person is the manufacturer of that device and is based in Great Britain, the person informs the Secretary of State of the address of their registered place of business in Great Britain;

ii

that person is the manufacturer of that device and is based outside the United Kingdom, and the manufacturer appoints a sole UK responsible person, and that UK responsible person provides the Secretary of State with written evidence that they have the manufacturer’s authority to act as their UK responsible person; or

iii

that person is not the manufacturer of the device, the address of that person’s registered place of business in Great Britain has been provided to the Secretary of State by the manufacturer or the UK responsible person;

b

that person supplies the Secretary of State with a description of the relevant device; and

c

that person pays to the Secretary of State the relevant fee in accordance with regulation 53.

2A

The person responsible for providing information in accordance with paragraph (2) must inform the Secretary of State of any changes to that information.

3

The UK responsible person appointed in accordance with paragraph (2)(a)(ii) must—

a

ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;

b

keep available to the Secretary of State a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements;

c

in response to a request from the Secretary of State, provide the Secretary of State with all the information and documentation necessary to demonstrate the conformity of a device;

d

where they have samples of the device or access to the device, comply with any request from the Secretary of State to provide such samples or access;

e

where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the Secretary of State to provide such samples or access, and communicate to the Secretary of State whether the manufacturer intends to comply with that request;

f

cooperate with the Secretary of State on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;

g

immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been appointed;

h

if the manufacturer acts contrary to its obligations under these Regulations—

i

terminate the legal relationship with the manufacturer; and

ii

inform the Secretary of State and, if applicable, the relevant approved body of that termination.

4

In this regulation—

a

the references to “technical documentation” are to be construed in accordance with Annex 2, 3 or 5;

b

the references to “declaration of conformity” are to be construed in accordance with Annexes 2, 3 and 5.