Division 4 F1

The manufacturer shall undertake to institute and keep updated a F2post-marketing surveillance system including the provisions referred to in Annex 7 . This undertaking shall include the obligation on the part of the manufacturer to notify the competent authorities of the following events immediately on learning of them:

1. (i)

   any change 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 deterioration in his state of health;

2. (ii)

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