# The Medical Devices Regulations 1994, Regulation 18: Prohibition on supply etc.


(1) Subject to paragraph (6) the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device, which constitutes placing on the market or putting into service a device which does not comply with the relevant essential requirements, is prohibited.
(2) Subject to paragraphs (3) and (6), the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device—
(a) which does not bear the CE marking as required by regulation 6(1); or
(b) which bears a mark in contravention of regulation 6(3),
is prohibited.
(3) Paragraph (2)(a) does not apply to a device which is custom-made or intended for clinical investigation.
(4) The supply of a custom-made device in respect of which the manufacturer has contravened regulation 15 is prohibited.
(5) The supply, in contravention of regulation 16(1) or a notice under regulation 16(2), of a device intended for clinical investigation is prohibited.
(6) Nothing in paragraphs (1) or (2) prevents the offer to supply, the exposure for supply or the possession for supply at a trade fair, exhibition, demonstration or similar event of a device which does not comply with the relevant essential requirements or which does not bear the CE marking, provided that a notice is prominently displayed at the event, so as to be readily visible to a prospective purchaser, indicating that the device—
(a) does not comply with those requirements or does not bear that marking; and
(b) may not be put into service until it complies with the requirements of the Directive.

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/18 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.