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) (c. 722)

Article 2 U.K.

For the purposes of this Regulation, the following definitions apply in addition to the definitions set out in [F1 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(1);

(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.

Textual Amendments

F1 Words in Art. 2 substituted (11.8.2021) by The Medical Devices (Amendment) (EU Exit) Regulations 2021 (S.I. 2021/873), reg. 1(1), Sch. 2 para. 9

(1)

OJ L 147, 31.5.2001, p. 1.