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

Amendment of Schedule 7 to the principal Regulations

17.—(1) Schedule 7 to the principal Regulations (EC verification procedure) shall be amended in accordance with the following provisions of this regulation.

(2) In paragraph 1 for the word “homogeneity” there shall be substituted the word “uniformity”.

(3) After paragraph 1 there shall be inserted the following paragraph—

“1A.   The manufacturer or his authorised representative—

(a) shall take all measures necessary in order that the manufacturing process ensures conformity of the products to the type as described in the EC type-examination certificate and to the requirements of the Directive that apply to them; and

(b) shall affix the CE marking to each product and draw up a written declaration of conformity.”.

(4) In sub-paragraph (2)(a) of paragraph 2 for the words “any deterioration” there shall be substituted the words “any change”.

(5) For sub-paragraph (1) of paragraph 3 there shall be substituted the following sub-paragraph—

“(1) The notified body shall carry out the appropriate examination and tests in order to check the conformity of the product to the requirements of the Directive by examination and testing of products on a statistical basis in accordance with paragraph 4.”.

(6) For sub-paragraph (1) of paragraph 4 there shall be substituted the following sub-paragraph—

“(1) The manufacturer shall present the manufactured products to the notified body in the form of uniform batches, and shall take all necessary measures in order that the manufacturing process ensures the uniformity of each batch produced.”.

(7) In sub-paragraph (4)(b) of paragraph 4 for the words “non-conformity percentage of” there shall be substituted the words “percentage of non-conformity”.

(8) In sub-paragraph (5) of paragraph 4 after the words “the notified body” there shall be inserted the words “shall affix, or cause to be affixed, its identification number to each device and”.

(9) After sub-paragraph (6) of paragraph 4 there shall be inserted the following sub-paragraph—

“(6A) In the event of frequent rejection of batches, the notified body may suspend the statistical verification.”.

(10) In sub-paragraph (7) of paragraph 4 for the word “logo” there shall be substituted the word “number”.

(11) After sub-paragraph (7) of paragraph 4 there shall be added the following sub-paragraph—

“(8) The manufacturer or his authorised representative shall ensure that he is able to supply the notified body’s certificates of conformity on request.”.