Division 3.1

The manufacturer shall make an application for evaluation of his quality system to a notified body.

The application shall include:

• all the appropriate items of information for the category of products manufacture of which is envisaged,

• the quality-system documentation,

• an undertaking to fulfil the obligations arising from the quality system as approved,

• an undertaking to maintain the approved quality system in such a way that it remains adequate and efficacious,

• F1an undertaking by the manufacturer to institute and keep updated a post-marketing surveillance system including the provisions referred to in Annex 7. The undertaking shall include an obligation for the manufacturer to notify the competent authorities of the following incidents immediately on learning of them:

  1. (i)

     any deterioration in the characteristics or performances, and any inaccuracies in the instruction leaflet for a device which might lead to or have led to the death of a patient or a deterioration in his state of health;

  2. (ii)

     any technical or medical reason resulting in withdrawal of a device from the market by the manufacturer.