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

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

• the quality-system documentation,

• F1the 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.

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.

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