Essential requirements for active implantable medical devicesU.K.
22.—(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 [F1and 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 [F2and the requirements set out in Regulation (EU) No 722/2012 (if applicable)].
Textual Amendments
F1Words in reg. 22(1) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 10
F2Words in reg. 22(2) inserted (21.10.2013) by The Medical Devices (Amendment) Regulations 2013 (S.I. 2013/2327), regs. 1(2), 10