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,

• all the relevant information on the product or product category covered by the procedure,

• a written declaration that no application has been lodged with any other notified body for the same product-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,

• F1an 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, including the provisions referred to in Annex X, and to implement appropriate means to apply any necessary corrective action. This undertaking must include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:

  1. (i)

     any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the instructions for use which might lead to or might have led to the death of a patient or user or to a serious deterioration in his state of health;

  2. (ii)

     any technical or medical reason connected with the characteristics or performance of a device leading for the reasons referred to in subparagraph (i) to systematic recall of devices of the same type by the manufacturer.