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

Amendment of regulation 5 of the principal Regulations

6.—(1) Regulation 5 of the principal Regulations (procedure for affixing EC mark) shall be amended in accordance with the following provisions of this regulation.

(2) In paragraph (2) after the word “manufacturer” there shall be inserted the words “or his authorised representative”.

(3) In sub-paragraph (c) of paragraph (2) for the word “specimens” there shall be substituted the word “examples”.

(4) In paragraph (4) for the words “a notified body verifies and certifies” there shall be substituted the words “the manufacturer ensures and declares”.

(5) In paragraph (5) after the word “manufacturer” there shall be inserted the words “or his authorised representative” and in sub-paragraph (d) for the word “specimens” there shall be substituted the word “examples”.

(6) After paragraph (6) there shall be inserted the following paragraphs—

“(6A) Any manufacturer of a device or any notified body following a conformity assessment procedure for affixing the CE marking to a device shall take account of the results of any assessment or verification operation which has been carried out in accordance with the Directive or these Regulations at any intermediate stage of manufacture of the device.

(6B) Where a conformity assessment procedure involves the intervention of a notified body, the manufacturer of a device or his authorised representative may apply to any notified body which has been designated in accordance with Article 11 of the Directive to carry out tasks in respect of that type of device for the purposes of that conformity assessment procedure.

(6C) Where a manufacturer has supplied information or data to a notified body in the course of a conformity assessment procedure, the notified body may require the manufacturer to provide any additional information or data which the notified body considers necessary for the purposes of that procedure.

(6D) A decision made by a notified body in accordance with Schedule 5 or Schedule 6 shall—

(a) specify the period of validity of the decision; and

(b) be valid for an initial period of not more than 5 years.

(6E) Where an agreement under which a notified body agrees to carry out a conformity assessment procedure for a manufacturer allows the manufacturer to apply to the notified body at a specified time for an extension of the period of validity of a decision mentioned in paragraph (6D), the notified body may extend the validity of the decision for further periods of 5 years, each such period commencing on the expiry of the preceding period.

(6F) Where the procedures referred to in this regulation have not been carried out in relation to an individual device, the Secretary of State may authorise the placing on the market and putting into service of that device if she is satisfied that this would be in the interest of the protection of health.”.