# The Medical Devices (Amendment) Regulations 2013, Regulation 2: Amendment of regulation 2 of the 2002 Regulations


(1) Regulation 2 of the 2002 Regulations (interpretation) is amended as follows.
(2) In paragraph (1) omit the following definitions—
(a) “animal”;
(b) “Directive 2003/32”;
(c) “EEA State”;
(d) “non-viable”; and
(e) “tissue”.
(3) In paragraph (1) for the definition of “European Economic Area” substitute—
““European Economic Area” means the European Economic Area created by the EEA Agreement;”.
(4) In paragraph (1) in the definition of “the Medical Devices Directives” for “read with Directive 2003/32” substitute “both read with Regulation (EU) No 207/2012 and Regulation (EU) No 722/2012”.
(5) In paragraph (1) after the definition of “putting into service” insert the following definitions—
““Regulation (EU) No 207/2012” means Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices;
“Regulation (EU) No 722/2012” means 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;”.
(6) After paragraph (1A) insert the following paragraph—
“(1B) In these Regulations, any reference to Annex 1 to Directive 90/385 or to Annex I to Directive 93/42 is to that Annex read with Regulation (EU) No 207/2012.”.

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Source: https://www.legislation.gov.uk/uksi/2013/2327/regulation/2 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-regulations-2013/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.