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

Amendment of Schedule 5 to the principal Regulations

15.—(1) Schedule 5 to the principal Regulations (EC declaration of conformity procedure) shall be amended in accordance with the following provisions of this regulation.

(2) In sub-paragraph (1) of paragraph 2 after the words “The application” there shall be inserted the words “shall be signed by or on behalf of the manufacturer and”.

(3) In sub-paragraph (4)(b)(ii) of paragraph 3 for the words “harmonised Standards” there shall be substituted the words “the manufacturer’s standards of quality”.

(4) For sub-paragraph (4) of paragraph 10 there shall be substituted the following paragraph—

“(4) The notified body shall make available to the other notified bodies or to the Secretary of State, on their or her request, the information necessary to establish in respect of which quality systems it has issued, refused or withdrawn approval.”.

(5) After sub-paragraph (4) there shall be added the following paragraphs—

“(5) For at least five years from the last date of manufacture of the device, the manufacturer shall keep available for the Secretary of State—

(a) the declaration of conformity;

(b) the documentation referred to in paragraph 2(1)(c);

(c) any modification plans referred to in paragraph 5(1);

(d) the documentation referred to in paragraph 6(2); and

(e) the decisions and reports of the notified body referred to in paragraphs 5(3), 7(1), 10(2) and 10(3).

(6) Where neither the manufacturer nor his authorised representative is established in the Community, the obligation to keep available the technical documentation referred to in paragraph 6(2) shall fall upon the person responsible for placing the device on the market.”.