# 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 16

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

A justification for the use of animal tissues or derivatives in the medical device, including a rationale for the acceptability of the overall TSE risk estimate, the evaluation of alternative materials and the expected clinical benefit:

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Source: https://www.legislation.gov.uk/eur/2012/722/annex/II/division/2/division/6/division/16 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-722/annex-II/division-2/division-6/division-16
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.