The Medical Devices Regulations 2002

Compliance notices U.K.

62.—(1) 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 a relevant device or a device for performance evaluation is a device in respect of which there is a failure to comply with these Regulations, 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 the device is a device in respect of which there is failure to comply with these Regulations and the reasons for that suspicion;

(c) specifying the relevant provision of these Regulations and, where applicable, any relevant provision of the Medical Devices Directives;

(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 specified provision 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 in 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 or the 1987 Act in respect of that device or any device of the same type supplied by that person.

(2) Where an enforcement authority serves a notice referred to in paragraph (1), 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 (1)(d) has expired and unless, in relation to the alleged failure to comply with these Regulations, at the expiry of that period the person on whom the notice was served has failed to comply with its requirements.

(3) The notice referred to in paragraph (1) may include directions as to the measures to be taken by the person on whom the notice is served to secure compliance with the provisions of these Regulations, including different ways of securing compliance, and any such directions are requirements of the notice for the purposes of paragraph (2).