# The Medical Devices (Amendment) (EU Exit) Regulations 2021, Paragraph 7


For Article 8 (which relates to review of obligations by a notified body) substitute—
“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.”.

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Source: https://www.legislation.gov.uk/uksi/2021/873/schedule/2/paragraph/7 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-eu-exit-regulations-2021/schedule-2/paragraph-7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.