# The Medical Devices Regulations 1994, Regulation 19: Enforcement etc.


(1) Notwithstanding that they are made partly in exercise of powers other than those conferred by section 11 of the 1987 Act, these Regulations shall be regarded for all purposes relating to enforcement (whether by criminal proceedings or notices or otherwise) and for the purposes of section 38 of that Act (disclosure of information) as safety regulations as defined in that Act and any provision of these Regulations made under those other powers shall be regarded for those purposes as a safety provision as defined in that Act.
(2) Except as provided by paragraph (3), each weights and measures authority in Great Britain and each district council in Northern Ireland is relieved of its duty imposed by section 27(1) of the 1987 Act in so far as it is exercisable in relation to devices, and that duty is transferred to the Secretary of State.
(3) Paragraph (2) shall not relieve an authority or council of its duty in relation to devices which are consumer goods for the purposes of Part II of the 1987 Act and accordingly each weights and measures authority in Great Britain and each district council in Northern Ireland shall, concurrently with the Secretary of State, enforce these Regulations in relation to such devices.
(4) Each authority and council referred to in paragraph (3) on whom a duty is imposed by section 27(1) of the 1987 Act to enforce the provisions of these Regulations shall give immediate notice to the Secretary of State of—
(a) any suspension notice served by it under section 14 of that Act in respect of a device to which paragraph (3) applies;
(b) any application made by it under section 16 of that Act for an order for forfeiture of any such device; and
(c) any other thing done by it in respect of such a device for the purposes of, or in connection with the operation of, sections 14 to 17 of that Act.
(5) The powers conferred by section 13 of the 1987 Act to serve prohibition notices and notices to warn are exercisable in relation to non-conforming devices as they are exercisable in relation to relevant goods which the Secretary of State considers are unsafe (as well as being exercisable in relation to such goods), and in relation to non-conforming devices Schedule 2 to the 1987 Act shall have effect as if references to goods being unsafe or safe were references to devices being or not being non-conforming devices.
(6) In paragraph (5) “non-conforming devices” means devices which, whether or not the Secretary of State considers them unsafe, she considers to be devices to which the CE marking has been wrongly applied and to be devices—
(a) which do not conform as respects a relevant essential requirement to a relevant national Standard where the device is held out as respects that essential requirement as conforming to that Standard;
(b) where the devices are ones to which the CE marking has been applied following the EC declaration of conformity procedure, in respect of which the manufacturer or his authorised representative has failed to comply with his obligations under that procedure; or
(c) where the devices are ones to which the CE marking has been applied following the EC type-examination procedure, which do not conform to the type described in the relevant EC type-examination certificate or which conform to such a type which does not meet the relevant essential requirements.
(7) Except in the case of a device which in the opinion of an enforcement authority is likely to compromise the health or safety of any person, where an enforcement authority has reasonable grounds for suspecting that the CE marking has been affixed to any device in relation to which any provision of these Regulations has not been complied with, that authority may serve upon the manufacturer or his authorised representative a notice—
(a) specifying the description of the device to which the notice relates;
(b) stating that the enforcement authority suspects that the CE marking has been affixed to the device in circumstances where a provision of these Regulations has not been complied with and the reasons for that suspicion;
(c) specifying the provision referred to in sub-paragraph (b);
(d) requiring the person on whom the notice is served—
(i) to secure that any device to which the notice relates conforms as regards the provision concerning the CE marking within such period as may be specified in the notice, or
(ii) to provide evidence within that period to the satisfaction of the enforcement authority that all the provisions of these Regulations have been complied with so far as they relate to that device; and
(e) warning the person on whom the notice is served that unless the requirements of sub-paragraph (d) are met, further action may be taken under these Regulations in respect of that device or any device of the same type supplied by that person.
(8) Where an enforcement authority serves a notice referred to in paragraph (7), section 14, 16 or 17 of the 1987 Act shall not be applied as respects any device to which the notice relates until the period referred to in paragraph (7)(d) has expired and unless at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.
(9) The notice referred to in paragraph (7) may include directions as to the measures to be taken by the person on whom the notice is served to secure conformity of the device with the provisions of these Regulations including different ways of securing conformity; and any such directions as are included are requirements of the notice for the purposes of paragraph (8).

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/19 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-19
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.