The In Vitro Diagnostic Medical Devices Regulations 2000

8.—(1) In paragraph (3) of regulation 19 of the 1994 Regulations (enforcement etc.), after the words “and accordingly” there shall be added the words “ but subject to paragraph (3A),”.

(2) After paragraph (3) of regulation 19 of the 1994 Regulations there shall be inserted the following paragraph—

“(3A) The powers of an enforcement authority to serve restriction notices under regulation 19A are only exercisable by the Secretary of State.”.

(3) For paragraphs (6) and (7) of regulation 19 of the 1994 Regulations there shall be substituted the following paragraphs—

“(6) In paragraph (5), “non-conforming devices” means devices which, whether or not the Secretary of State considers them unsafe, are devices with or which require a CE marking which he considers to be devices—

(a) which do not conform as respects a relevant essential requirement; or

(b) to which a CE marking has or should have been applied following the EC declaration of conformity assessment procedure set out in the Directive, and—

(i) the manufacturer or his authorised representative has failed to comply with his obligations under that procedure, or

(ii) they do not conform to the design or type described in any relevant EC design-examination or EC type-examination certificate.

(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 a device 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;

(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 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.”.