ANSM Issues Instructions For Clients of Denotified Bodies
French manufacturers that are clients of denotified bodies, or notified bodies that cease operation, can apply to the National Agency for the Safety of Medicines and Health Products (ANSM) to continue marketing their devices.
To apply for a marketing extension, a manufacturer must submit:
- A list of the references for all devices affected by the denotification decision;
- The sales volume and the European Union member states in which the devices 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; and
- Identification of a new notified body, evidence that the certification process has been initiated and the anticipated date that it will be finalized. — Jeff Kinney