Division 3.1

The manufacturer must lodge an application for assessment of his quality system with a notified body.

The application must include:

• the name and address of the manufacturer and any additional manufacturing site covered by the quality system,

• adequate information on the device or device category covered by the procedure,

• a written declaration that no such application has been lodged with any other notified body for the same device-related quality system,

• the documentation on the quality system,

• an undertaking by the manufacturer to fulfil the obligations imposed by the quality system approved,

• an undertaking by the manufacturer to keep the approved quality system adequate and efficacious,

• an undertaking by the manufacturer to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective action and notification as referred to in Annex III, section 5.