What Happens if a Notified Body is De-Notified?

Within the EU, notified bodies have ceased operations following a de-notification decision from their member state’s competent authority. Medical devices can only receive marketing authorisation with a valid certificate and under regular device surveillance by a notified body.

However, due to what ANSM calls a “lack of specific provisions in both French and European regulations regarding the future of CE certificates in the event a notified body is de-notified (i.e. a competent authority has suspended or withdrawn the NB’s authorisation) or stops operating,” ANSM is implementing a procedure for manufacturers headquartered in France.

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.

Procedures

ANSM has decided that for medical device manufacturers with valid CE certificates, the marketing of the concerned devices and in-vitro medical devices can continue until the end of the initial period of validity of the certificates, and in all instances within a maximum limit of 12 months following de-notification or the effective end of activities of the notified body provided that the following has been submitted to and favourably evaluated with:

  • a list of the references for all devices affected by the de-notification decision or the end of operations, which ANSM says “should also specify the sales volume and the European Union member states in which they are being marketed and/or distributed”
  • a copy of the most current version of the CE compliance certificates identifying the devices covered by these certificates
  • a statement issued by the manufacturer certifying that its products continue to comply with fundamental requirements
  • identification of the new notified body, evidence that the certification process has been initiated, and the anticipated date that it will be finalised

As soon as possible, the audit report drafted by the new notified body should also be sent to ANSM as well as the new certificate.

Read the full story at RAPS.

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Published on 15. November 2016 in News EU, News France