reg 13 Procedures for affixing a UK marking to general medical devices
(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) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .