The Active Implantable Medical Devices Regulations 1992

Prohibition on supply etc.

9.—(1) Subject to paragraph (6), the supply, offer to supply, agreement to supply, exposure for supply or possession for supply of a device which has been placed on the market or put into service and 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 EC mark as required by regulation 4(1); or

(b) which bears a mark in contravention of regulation 4(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 or his authorised representative has contravened regulation 6 is prohibited.

(5) The supply, in contravention of regulation 7(1) or a notice under regulation 7(2), of a device intended for clinical investigation is prohibited.

(6) Nothing in paragraph (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 EC mark 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 mark; and

(b) may not be put into service until it complies with the requirements of the Directive.