# Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (Text with EEA relevance), Article 8

Extent: E+W+S+N.I.

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/eur/2012/207/article/8 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-207/article-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.