The Active Implantable Medical Devices Regulations 1992

Regulation 8

SCHEDULE 9NOTIFIED BODIES — CONDITIONS

1.—(1) The body, its director and its staff responsible for carrying out operations relating to evaluation and verification—

(a)shall neither be, nor be the authorised representative of, the designer, manufacturer, supplier or installer of devices which they evaluate;

(b)shall neither be, nor represent any person who is, directly involved in the design, construction, marketing or maintenance of those devices.

(2) Nothing in sub-paragraph (1) precludes the possibility of exchanges of technical information between a manufacturer and the body.

2.  The body and its staff must—

(a)carry out operations relating to evaluation and verification with the highest degree of professional integrity and technical competence;

(b)be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of an evaluation, especially from those with an interest in the result of the evalution.

3.—(1) The body must be able to carry out all the tasks as respects which it is or is to be designated under regulation 8, whether they are or are to be carried out by the body itself or under its responsibility.

(2) In particular the body must—

(a)have at its disposal the necessary staff; and

(b)possess the necessary facilities,

to enable it to perform properly the technical and adminstrative tasks relating to evaluation and verification; and must have access to the equipment necessary for the verifications required.

4.  The staff responsible for evaluation and verification must have:

(a)appropriate vocational training covering all the operations of evaluation and verification for which the body has been designated;

(b)satisfactory knowledge of the requirements of the controls they carry out and adequate experience of the operations of evaluation and verification for which the body has been designated;

(c)the ability required to draw up the certificates, records and reports to demonstrate that the controls have been carried out.

5.  The impartiality of staff carrying out evaluations and verifications must be guaranteed, and their remuneration must not depend on the number of procedures carried out, nor on the results of the evaluations and verifications.

6.  The body must keep itself insured against liabilities incurred in the performance of its functions, except to the extent that any liability would be met by the Crown, a government Department or a body exercising functions on behalf of the Crown.

7.  The staff of the body must observe professional secrecy with regard to all information gained in carrying out their tasks (except vis-a-vis the competent authorities of any member State in which their activities are carried out) under the Directive or these Regulations.

8.  The body must undertake to carry out the inspections referred to in paragraph 10(2) of Schedule 5 with a frequency to be agreed with the Secretary of State, and, once having become a notified body must fulfil the terms of that undertaking.

9.  The body must undertake to comply with Articles 13 and 15 of the Directive (measures where EC mark has been wrongly affixed and duty of confidentiality), and, once having become a notified body, must fulfil the terms of that undertaking.