The Active Implantable Medical Devices (Amendment and Transitional Provisions) Regulations 1995

Insertion of regulations 10A and 10B into the principal Regulations

11.  After regulation 10 of the principal Regulations (enforcement etc.) there shall be inserted the following regulations—

“Unduly affixed CE marking

10A.— (1) Except in the case of a device which the Secretary of State considers to be unsafe, where she 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, she 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 she 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 Secretary of State 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 requirement of sub-paragraph (d) is 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.

(2) Where the Secretary of State serves a notice referred to in paragraph (1), sections 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 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 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 (2).

Centralised system of records etc.

10B.   The Secretary of State shall perform, as respects the United Kingdom, the functions of the member State under Article 8 of the Directive.”.