reg 27 Procedures for affixing a UK marking to active implantable medical devices
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).