# The Medical Devices Regulations 2002, Regulation 8: Essential requirements for general medical devices

Extent: E+W+S

(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.

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Source: https://www.legislation.gov.uk/uksi/2002/618/regulation/8 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-2002/regulation-8
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.