Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) (c. 385)

ANNEX 5 U.K. EC DECLARATION OF CONFORMITY TO TYPE(Assurance of production quality)

3. Quality system U.K.

3.4. The manufacturer shall inform the notified body which has approved the quality system of any plan to alter that system. U.K.

The notified body shall evaluate the proposed modifications and shall verify whether the quality system so modified would meet the requirements referred to in 3.2; it shall notify the manufacturer of its decision. This decision shall contain the conclusions of the control and a reasoned evaluation.