National requirements for the approval of medical devices in France
France is one of the most important markets for medical technology in Europe. Medical devices are approved in accordance with the Medical Device Regulation (MDR 2017/745) and supplementary national requirements of the French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM).
In addition to the CE marking, there are specific requirements for the registration, market surveillance and reimbursement of medical devices.
This article provides an overview of national regulation in France, which goes beyond the general EU requirements.
Competent authorities for medical devices in France
Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM)
The ANSM is the authority responsible for medical devices in France and monitors the safety, quality and performance of products.
Tasks of the ANSM:
- Registration of medical devices and market surveillance
- Evaluation of clinical trials
- Approval of high-risk medical devices
- Monitoring of vigilance messages and callbacks
Further information on the ANSM is available on the official website:
Obligation to register medical devices in France
In addition to EU-wide registration in EUDAMED, certain medical devices in France must be registered with the ANSM before being placed on the market.
Registration obligation for manufacturers and products
- Manufacturers must declare their establishment in France if they are based in France.
- All Class I medical devices must be registered with the ANSM before being marketed in France.
- Manufacturers who sell in-vitro diagnostics (IVD) must register in the French SIDIV database.
Registration process in France
- Creation of a user account in the ANSM registration system
- Registration of the manufacturer or authorized representative (EU-AR)
- Input of product data, including CE certificate and technical information
- Electronic submission of the registration
- Confirmation by the ANSM
The processing time is usually a few weeks to a few months.
Need for a local representative in France
Manufacturers based outside the European Union must appoint an Authorized Representative (EU-AR) to register and market their products in France.
Obligations of the authorized representative (EU-AR)
- Communication with the French authorities (ANSM)
- Registration in the ANSM database for manufacturers outside the EU
- Checking the technical documentation for conformity
Manufacturers based in France do not need an additional authorized representative, but must meet all regulatory requirements.
Classification of medical devices in France
Medical devices are classified in accordance with the EU Medical Device Regulation (MDR 2017/745) and do not differ from other EU member states.
Classification according to MDR
- Class I - Low risk (e.g. dressings, surgical instruments)
- Class IIa - Medium risk (e.g. infusion pumps, ultrasound devices)
- Class IIb - Higher risk (e.g. anesthesia machines, defibrillators)
- Class III - High risk (e.g. heart valves, artificial joints)
Special classifications in France
Some product groups are subject to additional national requirements, in particular:
- Medical devices with electronic components - registration with the ANSM required
- Blood and tissue products - Additional approval by ANSM
- In-vitro diagnostics - Registration in the SIDIV database
Approval procedure for medical devices in France
A medical device is approved throughout the EU via the CE marking. However, France has additional requirements for market launch and reimbursement by the healthcare system.
What approval procedures are there?
- CE marking according to MDR - mandatory for market entry
- Registration in the ANSM database for certain products
- Additional requirements for high-risk products - approval by ANSM required
Reimbursement procedure for medical devices in France
In addition to regulatory approval, reimbursement by the French healthcare system is a decisive factor for market success.
Important reimbursement procedures:
- Liste des Produits et Prestations Remboursables (LPPR)
- List of reimbursable medical devices in France
- Eligibility for reimbursement must be applied for and approved by the authorities
- Haute Autorité de Santé (HAS) rating
- Evaluation of the clinical efficacy of a medical device for inclusion in reimbursement
Average duration of approval procedures
- CE marking: 3 to 24 months depending on product class
- ANSM registration: A few weeks to a few months
- Reimbursement procedure: 6 to 24 months, depending on the procedure
Costs incurred
- ANSM registration: No direct fees for most products
- Notified body for CE certification: Depending on product class (10,000 - 100,000 euros)
- Reimbursement procedure: Costs for studies and applications can be high
Validity of registration and approval
- CE marking is generally valid for 5 years
- ANSM registration remains valid as long as the product is actively marketed
Language requirements
- Technical documentation can be submitted in English
- Instructions for use, labels and packaging must be available in French
Conclusion
France is an important medical technology market with additional national requirements for the registration and reimbursement of medical devices.
Important points summarized:
- ANSM registration is mandatory for certain medical devices
- Non-EU manufacturers require an authorized representative (EU-AR)
- Special requirements for in-vitro diagnostics and high-risk products
- Reimbursement processes are crucial for market success
- Technical documentation can be submitted in English, labels and instructions for use must be in French
Support from MEDAGENT
MEDAGENT offers comprehensive services for the French market:
- Registration with the ANSM
- Advice on CE marking and technical documentation
- Support for post-market surveillance and vigilance
For more information or assistance with the approval of medical devices in France, please contact us directly.
