French Competent Authority ANSM provides indications for manufacturers whose Notified Bodies are de-notified or stop operating.
New recommendations and procedures for manufacturers whose Notified Bodies terminate CE certification and auditing support have been issued by the French National Agency for the Safety of Medicines and Health Products (ANSM).
Such manufacturers may obtain marketing extensions for their devices until they find support by a new Notified Body.
According to the ANSM, companies whose Notified Bodies become denotified may continue marketing their devices in Europe until the initial validity of their CE certificates expires, and in “all instances” within a limit of 12 months following denotification of the Notified Body in question.
Manufacturers should, however, demonstrate that they are in the process of signing up with a new Notified Body. They are also required to submit the following documents to the ANSM:
- List of references for all medical devices and IVDs affected by the denotification, along with data on sales volumes and European member states where they are marketed
- Copy of most up-to-date CE certificates for all devices affected by the denotification
- Manufacturer attestation that all affected devices remain in compliance with “fundamental requirements”
- Identification of selected new Notified Body along with proof that certification efforts with the new entity have begun and anticipated date of finalization
- As soon as possible, audit report and new certificate from the manufacturer’s new Notified Body
Manufacturers with expired certificates or whose certificates’ validity expires after their Notified Bodies’ denotifications do not qualify for marketing extensions. However, the Competent Authority may decide to grant an extension in cases where a device is essential to public health or for which no alternative products are available.