# 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 1.1: Justification for the use of animal tissues or derivatives

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

The manufacturer must justify, on the basis of his overall risk analysis and risk management strategy for a specific medical device, the decision to use animal tissues or derivatives, referred to in Article 1, (specifying animal species, tissues and sourcing) taking into account the clinical benefit, potential residual risk and suitable alternatives (such as lower risk tissues or synthetic alternatives).

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Source: https://www.legislation.gov.uk/eur/2012/722/annex/I/division/1/division/1.1 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-1/division-1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.