# The Medical Devices Regulations 2002, Regulation 27: Procedures for affixing a UK marking to active implantable medical devices

Extent: E+W+S

A relevant device may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Annex 2, or
(ii) Annex 3, together with Annex 4 or 5;
(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part that apply to it; ...
(c) ensures that the device meets the provisions of this Part which apply to it; and
(d) fulfils the obligations imposed by Regulation (EU) No 722/2012 (if applicable).

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/27 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-27
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.