The Medical Devices Regulations 2002

[F1 Meaning of approved body and UK notified body E+W+S

A45.— (1) An approved body is a conformity assessment body which—

(a) has been designated by the Secretary of State pursuant to the procedure set out in regulation 45 (designation etc. of approved bodies); or

(b) immediately before IP completion day was a UK notified body in respect of which the Secretary of State has taken no action under regulation 45(5) to withdraw a designation.

(2) In this regulation—

“UK notified body” means a body which the Secretary of State had before IP completion day notified to the European Commission in accordance with Article 3(7) of Commission Implementing Regulation (EU) 920/2013 or under Article 15 of Directive 98/79.”.]

Textual Amendments

F1 Reg. A45 inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 7(3) (as amended by S.I. 2020/1478, reg. 1(3), Sch. 2 paras. 2, 47(3)); 2020 c. 1, Sch. 5 para. 1(1)