For several months now, notified bodies in the EU have ceased operations, either voluntarily or following a de-notification decision from their member state’s competent authority.
As the uptick in notified body closures increases, France’s National Agency for the Safety of Medicines and Health Products (ANSM) on Monday reiterated that medical devices may only receive marketing authorization with a valid certificate and under regular device surveillance by a notified body.
ANSM also explained that it is not the job of competent authorities to replace notified bodies, as these activities constitute contractual relations between notified bodies and manufacturers and as such are governed by private law.
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the future of CE certificates in the event a notified body is de-notified (i.e. a competent authority has suspended or withdrawn the NB’s authorization) or stops operating,” ANSM is implementing a procedure for manufacturers headquartered in France.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.
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.
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 favorably 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 finalized
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.
“For a manufacturer who has expired certificates at the time of the application period, or if the validity date does not fall after the date of the notified bodies’ de-notification, ANSM shall not grant an extension for the marketing of the medical devices concerned,” the regulator says. “However, if a medical device is essential or has no existing alternative, ANSM will examine the manufacturer’s application on an individual basis. In this particular situation, it is the manufacturer’s responsibility to provide evidence of the essential nature of the medical device.”
De-notification or termination of notified bodies’ activities