The Active Implantable Medical Devices Regulations 1992

Procedure for affixing EC mark

5.—(1) A device may bear the EC mark only if its manufacturer —

(a) follows the EC declaration of conformity procedure; or

(b) follows the EC type—examination procedure, together with —

(i) the EC verification procedure, or

(ii) the EC declaration of conformity to type procedure.

(2) The EC declaration of conformity procedure is the procedure by which the manufacturer —

(a) applies an approved quality system for the design, manufacture and final inspection of devices, and is subject to surveillance to ensure that he duly fulfils his obligations arising from the approved quality system;

(b) ensures and declares that the devices satisfy the relevant provisions of the Directive and, in particular, the relevant essential requirements; and

(c) having applied the EC mark in accordance with regulation 4, draws up and keeps a written declaration of conformity with the relevant provisions of the Directive, covering one or more identified specimens of the devices,

and Schedule 5 (Part I of which relates to the quality system, including the design dossier, and Part II of which relates to surveillance) shall have effect for the purposes of that procedure.

(3) The EC type—examination procedure is the procedure by which a notified body ascertains and certifies that a representative sample of the production of devices envisaged satisfies the relevant provisions of the Directive; and Schedule 6 shall have effect for the purposes of that procedure.

(4) The EC verification procedure is the procedure by which a notified body verifies and certifies that devices conform to the type described in an EC type—examination certificate and satisfy the relevant provisions of the Directive; and Schedule 7 shall have effect for the purposes of that procedure.

(5) The EC declaration of conformity to type procedure is the procedure by which the manufacturer —

(a) applies a quality system approved for the manufacture of devices and conducts a final inspection of the devices;

(b) is subject to surveillance;

(c) ensures and declares that the devices conform to the type described in an EC type—examination certificate and conform to the relevant provisions of the Directive; and

(d) having applied the EC mark in accordance with regulation 4, draws up and keeps a written declaration of conformity with the relevant provisions of the Directive covering one or more identified specimens of the devices,

and Schedule 8 (Part I of which relates to the quality system and inspection and Part II of which relates to surveillance) shall have effect for the purposes of that procedure.

(6) Any part of the EC type—examination procedure or the EC verification procedure which is to be followed in the United Kingdom by a manufacturer who has no place of business there may instead be followed by his authorised representative.

(7) The documentation relating to any of the procedures mentioned in this regulation carried out in the United Kingdom shall be in English or, subject to regulation 3(4), in some other language acceptable to the notified body concerned.

(8) A notified body may charge a fee in accordance with paragraphs (9), (10) and (11) for anything done in, or in connection with, performing a function under this regulation or under any of the Schedules referred to in it.

(9) Except as provided by paragraph (10) the fee charged in respect of anything done shall not exceed an amount which reasonably represents the cost incurred, or to be incurred, in doing it.

(10) Where the notified body is a body the activities of which are carried on for profit, the fee for doing anything may include an amount representing a profit which is reasonable in the circumstances, having regard to —

(a) the character and extent of the work done or to be done by the notified body; and

(b) the commercial rate normally charged in respect of profit for that work or similar work.

(11) The notified body may require payment of a fee or a reasonable estimate of the fee, in advance of carrying out the work in respect of which the fee is payable and as a condition of doing that work.