Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
Emergo by UL
USA, Canada, Brazil, Australia, China, Hong Kong, Taiwan, India
A dedicated partner for medical device and IVD manufacturers, we offers deep local regulatory expertise through its offices in over 20 global locations. Services include product registration, human factors research, clinical strategy, and local in-country representation to ensure rapid, compliant market access worldwide.
February 2, 2025
Approximately 5 minutes
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.
Related Articles
Approximately 5 minutes
Medical Device Registration in France: Compliance with EU MDR and ANSM National Listing
France's medical device regulation is governed by the EU MDR. All devices require a **CE Mark** and must be registered locally with the national competent authority, the **ANSM**. Foreign manufacturers require an **EU Authorized Representative** to achieve market access.
Approximately 5 minutes
ANSM's Mission: Monitoring the Medical Device Lifecycle and Market Surveillance in France
The **ANSM** ensures the safety of medical devices in France by constantly monitoring the **benefit-risk balance** throughout their lifecycle. Its mission includes **market surveillance**, centralizing **vigilance** reports, controlling device advertising, conducting inspections, and enforcing corrective measures for non-compliance.
Approximately 5 minutes
French Medical Device Market Entry Costs: Budgeting for EU MDR Compliance (€50K to €300K)
Entering the French medical device market requires budgeting between **€50,000 and €300,000**, primarily driven by **CE Marking certification fees** and the complexity of the device's classification. Key expenses include Notified Body fees, technical documentation, French translation, and annual **Authorized Representative** costs.