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)

4. Surveillance U.K.

4.3. The notified body shall periodically carry out appropriate inspections and evaluations in order to ascertain that the manufacturer is applying the approved quality system, and shall supply the manufacturer with an evaluation report. U.K.