# The Medical Devices Regulations 2002, Regulation A45: Meaning of approved body and UK notified body

Extent: E+W+S

(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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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/A45 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-A45
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.