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The Medical Devices Regulations 2002

The Medical Devices Regulations 2002 reg A45

reg A45 Meaning of approved body and UK notified body

(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.”.

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