Except for medical devices of Class I, as defined in Annex IX to Directive 93/42, the fulfilment of the obligations laid down in Articles 4 to 7 of this Regulation must be reviewed by an approved body during the applicable conformity assessment procedure for the medical device in question, as set out in Part 2 or Part 3 of the Medical Devices Regulations 2002. The review must be based on a specific sampling method adapted to the class and the complexity of the product.]
Textual Amendments
F1Art. 8 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 7