# The Medical Devices Regulations 2002, Regulation 40: Procedures for affixing a UK marking to in vitro diagnostic medical devices

Extent: E+W+S

(1) A relevant device other than a device referred to in the lists in Annex II or a device for self-testing may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by Sections 1 to 5 of Annex III;
(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 which is a device for self-testing but which is not referred to in a list in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Sections 1 to 6 of Annex III,
(ii) Annex IV, or
(iii) Annex V and either Annex VI or Annex VII;
(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 referred to in List A in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Annex IV, or
(ii) Annexes V and VII;
(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 referred to in List B in Annex II may bear a UK marking only if its manufacturer or their UK responsible person—
(a) fulfils the applicable obligations imposed by—
(i) Annex IV,
(ii) Annexes V and VI, or
(iii) Annexes V and VII;
(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.

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/40 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-40
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.