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,

• 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 products,

• the documentation on the quality system,

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

• an undertaking to maintain the practicability and effectiveness of the approved quality system,

• where appropriate, the technical documentation on the types approved and a copy of the EC type-examination certificates,

• 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 labelling or 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 for the reasons referred to in subparagraph (i) above leading to a systematic recall of devices of the same type by the manufacturer.