# Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (Text with EEA relevance), Division 2.3: Increase of the overall TSE risk

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

Where on the basis of information submitted in accordance with section 2.1 or 2.2 an approved body establishes that the overall TSE risk in relation to a medical device is increased, this approved body shall follow the procedure set out in Article 5.

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Source: https://www.legislation.gov.uk/eur/2012/722/annex/I/division/2/division/2.3 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-2/division-2.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.