# The Medical Devices (Amendment) Regulations 2003, Regulation 2: Amendment of regulation 2 of the principal Regulations

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

In regulation 2(1) of the principal Regulations (interpretation)—
(a) the words “, unless the context otherwise requires” are omitted;
(b) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(c) after the definition of “Directive 2001/83”, there is inserted the following definitions—
““Directive 2003/12” means Commission Directive 2003/12 of 3rd February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices;
...”;
(d) in the definition of “the Medical Devices Directives”, after “Directive 93/42” there is inserted “ , read with Directive 2003/32 ”;
(e) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(f) in the definition of “notified body”, for “Part V of” there is substituted “ Part V or ”; and
(g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Source: https://www.legislation.gov.uk/uksi/2003/1697/regulation/2 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-regulations-2003/regulation-2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.