reg 8 Essential requirements for general medical devices
(1) Subject to regulation 12, 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 I which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) . (2) Subject to regulation 12, 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 been placed on the market or put into service, unless that device meets those essential requirements set out in Annex I which apply to it and the requirements set out in Regulation ( EU ) No 722/2012 (if applicable) . (3) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Part 1 of Schedule 2 to the Supply of Machinery (Safety) Regulations 2008 to the extent to which those essential health and safety requirements are more specific than the essential requirements to Directive 93/42.