reg 40 Procedures for affixing a UK marking to in vitro diagnostic medical devices
(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.