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.

4.1. The aim of surveillance is to ensure that the manufacturer duly fulfils the obligations which arise from the approved quality system. U.K.

4.2. The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular: U.K.

• the quality-system documentation,

• [F1 the technical documentation,]

• the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/calibrations and the qualifications of the staff concerned, etc.

Textual Amendments

F1 Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).

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.

4.4. In addition, the notified body may make unannounced visits to the manufacturer, and shall supply him with an inspection report. U.K.