The Medical Devices (Amendment) (EU Exit) Regulations 2021

Citation, commencement and application

1.—(1) These Regulations may be cited as the Medical Devices (Amendment) (EU Exit) Regulations 2021 and come into force on the twenty-first day after the day on which they are laid before Parliament.

(2) Regulations 2 and 3 apply in relation to England, Wales and Scotland only.

Amendment of the Medical Devices Regulations 2002

2.  The Medical Devices Regulations 2002(1) are amended in accordance with Schedule 1.

Amendment of EU tertiary legislation

3.  The following EU tertiary legislation concerning medical devices is amended in accordance with Schedule 2—

(a) Commission Decision 2002/364/EC of 7th May 2002 on common technical specifications for in vitro-diagnostic medical devices(2);

(b) Commission Regulation (EU) No 207/2012 of 9th March 2012 on electronic instructions for use of medical devices(3);

(c) Commission Regulation (EU) No 722/2012 of 8th August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin(4);

(d) Commission Implementing Regulation (EU) No 920/2013 of 24th September 2013 on the designation and supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42 on medical devices(5).

Signed by authority of the Secretary of State for Health and Social Care

Nadine Dorries

Minister of State,

Department of Health and Social Care

20th July 2021