8.—(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.
(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.