# The Medical Devices Regulations 2002, 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.

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/34 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-34
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.