The Medical Devices Regulations 2002

Designation etc. of EC conformity assessment bodies

48.—(1) The Secretary of State may designate for the purposes of the Mutual Recognition Agreements any corporate or other body as a body which is to carry out any of the tasks of a European Community conformity assessment body, and, if he so designates a body (referred to in these Regulations as an “EC CAB”), he shall designate the tasks which it is to carry out.

(2) A body may be designated under paragraph (1) as a body which is to carry out tasks of an EC CAB only if the Secretary of State considers that the body is capable of fulfilling the functions of an EC CAB arising out of the Mutual Recognition Agreements which it needs to be able to fulfil.

(3) The Secretary of State may refuse to designate a body under paragraph (1) if it fails to pay any fee payable under Part VI in connection with an application for designation.

(4) The Secretary of State may vary the tasks that an EC CAB may carry out, and if he does, those varied tasks will be the tasks which it is designated to carry out.

(5) The Secretary of State may place a restriction in relation to, or withdraw, any designation of a body under paragraph (1) if—

(a)the body so requests; or

(b)he considers that the body is not capable of fulfilling the functions of an EC CAB arising out of the Mutual Recognition Agreements which it needs to be able to fulfil,

and the Secretary of State may also withdraw any designation of a body under paragraph (1) if it fails to pay any fee payable under Part VI.

(6) Before—

(a)effecting a variation under paragraph (4); or

(b)restricting or withdrawing a designation under paragraph (5),

otherwise than at the EC CAB’s request, the Secretary of State shall give to the EC CAB an opportunity to make representations to him in writing and shall take into account any such representations as are made.

(7) For the purpose of deciding whether or not a body is capable of fulfilling the functions of an EC CAB arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, the Secretary of State may arrange for the inspection of—

(a)any premises occupied, or plant or equipment used, in connection with the carrying out of any such task; or

(b)any premises occupied, or plant or equipment used, by a manufacturer where the body is undertaking any task in relation to that manufacturer,

and may take into account for the purposes of his decision the results of any such inspection and any refusal to afford him such facilities or assistance as he may reasonably require in order to carry out any such inspection.

(8) The Secretary of State may request that an EC CAB supply to him any or all relevant information and documents, including budgetary documents, necessary for the purposes of deciding whether or not the body is capable of fulfilling the functions of an EC CAB arising out of the Mutual Recognition Agreements which it needs to be able to fulfil, and the body shall supply to him any and all relevant information or documents so requested.