# 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 1.2.7: Tissues or derivatives of animal origin coming into contact with the patients and users

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

The manufacturer must consider:
(a)the maximum quantity of animal tissues or derivatives coming into contact with the patient or user when using a single medical device;
(b)the contact area: its surface, type (e.g. skin, mucous tissue, brain) and condition (e.g. healthy or damaged);
(c)the type of the tissues or derivatives coming into contact with the patients or users;
(d)the period of time the device is intended to remain in contact with the body (including bioresorption effect); and
(e)the number of medical devices that could be used in a given procedure or, if possible, over the lifetime of a patient or user.

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Source: https://www.legislation.gov.uk/eur/2012/722/annex/I/division/1/division/1.2/division/1.2.7 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-722/annex-I/division-1/division-1.2/division-1.2.7
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.