The Active Implantable Medical Devices Regulations 1992

Notified bodies

8.—(1) The Secretary of State may approve for the purposes of Article 11 of the Directive any corporate or other body as a body which is to carry out tasks as part of a procedure mentioned in regulation 5 and, if he so approves a body, he shall designate the tasks which it is to carry out.

(2) A body shall be approved under paragraph (1) only if—

(a) it has applied to be, or agrees to be, so approved;

(b) it is a body in respect of which the conditions specified in Schedule 9 are fulfilled as respects the tasks which it is to carry out.

(3) The Secretary of State shall withdraw any approval of a body under paragraph (1) if the body so requests or if he considers that it is no longer a body in respect of which the conditions specified in Schedule 9 are fulfilled as respects the tasks which it is to carry out.

(4) The Secretary of State may vary the designation of tasks which a notified body is to carry out by—

(a) limiting or removing the tasks; or

(b) on the application of the notified body, extending or adding to the tasks.

(5) Before withdrawing an approval under paragraph (3), otherwise than at the notified body’s request, and before effecting a variation under paragraph (4)(a), the Secretary of State shall give to the notified body an opportunity to make representations to him in writing and shall take into account any such representations as are made.