reg 22 Essential requirements for active implantable medical devices
(1) Subject to regulation 26, no person shall place on the market or put into service a relevant device unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) . (2) Subject to regulation 26, no person shall supply a relevant device— (a) if that supply is also a placing on the market or putting into service of that device; or (b) in circumstances where that device has also been placed on the market or put into service, unless that device meets those essential requirements set out in Annex 1 which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) .