French Medical Device Regulators Have Posted New Rules for CE Approval

French regulators have published new information for manufacturers on adjusting to an expected decline in notified bodies in Europe due to increased stringent CE Marking and quality auditing requirements in the near future.

Medical device companies with valid CE certificates whose Notified Bodies become denotified may continue marketing their devices in Europe, until the end of their certificates’ initial validity.

However “orphaned” manufacturers may qualify for device marketing extensions in France under certain conditions until they obtain new notified body support. — Cynthia Jessup