# The Medical Devices Regulations 2002, Regulation 13: Procedures for affixing a UK marking to general medical devices

Extent: E+W+S

(1) A relevant device falling within Class I may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by Annex VII;
(b) declares, in accordance with the declaration of conformity procedure set out in that Annex, that the device meets the provisions of this Part which apply to it; and
(c) ensures that the device meets the provisions of this Part which apply to it.
(2) A relevant device falling within Class IIa may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Annex II, excluding Section 4 of that Annex, or
(ii) Annex VII, together with Annex IV, V or VI;
(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and
(c) ensures that the device meets the provisions of this Part which apply to it.
(3) A relevant device falling within Class IIb may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Annex II, excluding Section 4 of that Annex, or
(ii) Annex III, together with Annex IV, V or VI;
(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which apply to it; and
(c) ensures that the device meets the provisions of this Part which apply to it.
(4) A relevant device falling within Class III may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Annex II, or
(ii) Annex III, together with Annex IV or V;
(b) declares, in accordance with a declaration of conformity procedure set out in those Annexes, that the device meets the provisions of this Part which 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).
(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

---
Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/13 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-13
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.