# 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), Article 2

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

For the purposes of this Regulation, the following definitions apply in addition to the definitions set out in the Medical Devices Regulations 2002:
(a)‘cell’ means the smallest organised unit of any living form which is capable of independent existence and of replacement of its own substance in a suitable environment;
(b)‘tissue’ means an organisation of cells, extra-cellular constituents or both;
(c)‘derivative’ means a material obtained from animal tissue through one or more treatments, transformations or steps of processing;
(d)‘non-viable’ means having no potential for metabolism or multiplication;
(e)‘TSEs’ means all transmissible spongiform encephalopathies as defined in Article 3(1)(a) of Regulation (EC) No 999/2001 of the European Parliament and of the Council;
(f)‘TSE infectious agents’ means unclassified pathogenic agents which are capable of transmitting TSEs;
(g)‘reduction, elimination or removal’ means a process by which the number of TSE infectious agents is reduced, eliminated or removed in order to prevent infection or pathogenic reaction;
(h)‘inactivation’ means a process by which the ability to cause infection or pathogenic reaction by TSE infectious agents is reduced;
(i)‘source country’ means the country or countries in which the animal was born, has been reared and/or has been slaughtered;
(j)‘starting materials’ means raw materials or any other product of animal origin out of which, or with the help of which, the devices referred to in Article 1(1) are produced.

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