Medical Device Regulation in France
France is the second-largest medical device market in Europe and regulates devices under the EU Medical Device Regulation (EU MDR 2017/745). The National Agency for the Safety of Medicines and Health Products (ANSM) is the national competent authority. France has a particularly active vigilance system and plays a leading role in EU medical device policy through its involvement in MDCG and IMDRF.
Recent Regulatory Updates
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Sources Tracked by Qalico
Qalico continuously monitors 5 references across guidelines, regulations, and standards for France.
Regulations
Guidelines
Device Classification
France follows the EU MDR classification system. Class I devices are low risk (e.g., non-sterile dressings, manual wheelchairs). Class IIa devices are low-moderate risk (e.g., contact lens care products, diagnostic electrodes). Class IIb devices are moderate-high risk (e.g., condoms, infusion pumps). Class III devices are high risk (e.g., hip prostheses, coronary stents). Classification follows Annex VIII of EU MDR.
Official classification guidance →Official Regulatory Bodies
Official Guidance Documents
Official ANSM portal covering medical device regulation, matériovigilance, and regulatory guidance in France.
Guidance on France's matériovigilance system for reporting incidents and adverse events involving medical devices.
Information on the HAS evaluation process for medical device reimbursement in the French healthcare system.
The European database for medical device registration and UDI management across EU member states.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be placed on the French market.
- France has a robust matériovigilance system requiring mandatory reporting of incidents by manufacturers, healthcare professionals, and users.
- Notified body involvement is required for Class IIa, IIb, and III devices. France hosts the notified body GMED (LNE/G-MED).
- Non-EU manufacturers must designate an EU-based authorized representative.
- Reimbursement requires a separate evaluation by HAS/CNEDiMTS, which is independent from CE marking.
- Clinical investigations in France require ANSM authorization and ethics committee (CPP) approval.
Pre-Market Requirements
Devices must comply with EU MDR 2017/745 and bear CE marking. France hosts the notified body GMED (LNE/G-MED, NB 0459). Notified body assessment is required for Class IIa, IIb, and III devices.
Comprehensive technical documentation per EU MDR Annexes II and III is required, covering all aspects of device design, manufacturing, risk management, and clinical evidence.
Clinical evaluations per EU MDR Article 61 are mandatory. Clinical investigations in France require ANSM authorization and a favorable opinion from a Comité de Protection des Personnes (CPP).
Registration in EUDAMED is required. Manufacturers may also need to fulfill French national notification requirements with ANSM.
For devices seeking reimbursement in France, a separate application to HAS/CNEDiMTS is required. This evaluates the clinical benefit and added clinical benefit of the device.
Post-Market Requirements
France operates a comprehensive matériovigilance system. Manufacturers, healthcare professionals, and patients must report serious incidents to ANSM. This is coordinated with the EU-wide vigilance system under EU MDR.
PMS systems must be maintained per EU MDR. PSURs are required for Class IIa, IIb, and III devices. France may request additional national PMS data.
PMCF studies are required to continuously validate clinical safety and performance. France places particular emphasis on PMCF for high-risk implantable devices.
ANSM conducts regular inspections of manufacturers, authorized representatives, and distributors operating in France to verify compliance with EU MDR and national requirements.
International Recognition & Reliance
CE-marked devices under EU MDR are freely circulated across all EU/EEA member states.
CE-marked devices from EU member states are recognized in Switzerland under the MRA framework with certain conditions.