France: new publications on de-notification or termination of notified bodies

On November 14, 2016 the French National Agency for Safety of Medicines and Health Product (ANSM) has published new information for manufacturers on how to adjust to the situation when a notified body is de-notified or terminates its business. In two documents the French authority indicates the procedures put in place for medical device manufacturers that are affected by it.

The aim of this procedure is to keep products on the market under certain conditions until they reach the end of their initial period of validity, and in all instances within a maximum limit of 12 months following the de-notification or effective end of activities of the notified body.

The procedures are part of guidelines for managing situations created by notified body de-notifications that were unanimously agreed upon at the European Meeting of Competent Authorities (EMCA) on 19 October 2016.

The both documents can be found under:
ANSM – information Bulletin
ANSM – Questions and Answers