Regulation 34 Essential requirements for in vitro diagnostic medical devices
(1)
Subject to regulation 39, 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 39, 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.