Medical Device Registration in France: Compliance under the EU MDR and the ANSM

Medical Device Registration in France: Compliance under the EU MDR

Medical device registration and market access in France are primarily governed by the European Union’s legislative framework, specifically the Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Regulation (EU IVDR 2017/746).

1. The National Competent Authority (ANSM)

The national body responsible for overseeing the implementation and enforcement of the EU MDR/IVDR in France is the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM). While the registration process is centralized under the EU system, the ANSM is the national point of contact for manufacturers, importers, and distributors, handling market surveillance and vigilance reporting.

2. Mandatory Conformity Marking (CE Mark)

To be legally placed on the French market, a medical device must bear the CE Mark. Achieving the CE Mark requires:

• Classification: Determining the device class (I, IIa, IIb, III or IVDs) based on risk.
• Conformity Assessment: Low-risk devices (Class I non-sterile/non-measuring) can be self-certified. Higher-risk devices require assessment by an EU Notified Body to confirm compliance with the EU MDR’s General Safety and Performance Requirements (GSPRs).
• Technical Documentation: Creation and maintenance of a comprehensive Technical File/Design Dossier.
• Declaration of Conformity: The manufacturer’s written declaration that the device meets all regulatory requirements.

3. Registration Requirements

Under the EU MDR, registration is primarily conducted via the European Database on Medical Devices (EUDAMED).

• Manufacturer/Authorized Representative (AR): Manufacturers (or their appointed EU Authorized Representative for non-EU manufacturers) must register themselves and their devices in EUDAMED.
• Importer/Distributor: Importers and Distributors placing devices on the French market must also register their activities with the ANSM, ensuring full traceability of devices.
• UDI: Devices require a Unique Device Identification (UDI) to be entered into EUDAMED for tracking purposes.