Entering the French medical device market is not just about meeting one set of rules. Manufacturers must address both EU Medical Device Regulations and France-specific obligations. It is important to understand how these two sets of regulations work together to ensure market compliance.
Artixio has put this guide together to explain the France Medical Device Registration Process, device classification requirements, labeling obligations, and post-market responsibilities.
Regulatory Authorities for Medical Devices in France
ANSM is France’s national competent authority for medical devices. It operates under the French Ministry of Health. Market surveillance, vigilance reporting, clinical investigation authorisations and Notified Body designation are all regulated by ANSM. Manufacturers, authorized representatives, importers and distributors must comply with ANSM requirements.
But ANSM doesn’t work alone. Several EU-level bodies also shape how device regulation runs in France. They include:
The European Commission sets the primary legal basis. MDR (EU) 2017/745 governs all devices placed on the French market.
Notified Bodies carry out conformity assessments. France has two designated notified bodies: GMED and Afnor Certification. Both are in the NANDO database. Manufacturers can verify their designation status before engaging them for conformity assessment.
HAS/CNEDiMTS handles reimbursement, which is separate from CE marking. LPPR listing is essential for many reimbursable medical devices in France and usually requires a positive HAS assessment and pricing negotiation with CEPS.
France Medical Device Classification
Device classification in France is governed by MDR Article 51 and Annex VIII. The system is risk-based, with four main classes and subtypes. France applies this system without modification.
Manufacturers are responsible for applying the 22 classification rules and justifying their decision.
| Class | Risk level | Examples |
| Class I | Low |
Bandages, stethoscopes, Hospital beds
|
| Class Is/ Im/ Ir | Low (with specific features) |
Sterile dressings, measuring catheters, reusable surgical tools
|
| Class IIa | Medium |
Hearing aids, dental drills, infusion pump
|
| Class IIb | Higher-Medium |
Ventilators,contact lens
|
| Class III | Highest |
Pacemakers, heart valves
|
IVDs are regulated by a different set of rules, IVDR (EU) 2017/746, which includes four classes from A to D. France mandates an ANSM declaration for all IVD classes before they can enter the market.
SaMD is classified under MDR Annex VIII, Rule 11. Manufacturers can request classification guidance from ANSM through its Innovation and Guidance Window. MDCG 2021-24 is the primary reference.
Authorized Representative (AR) Requirements in France
Non EU manufacturers must designate an EU Authorised Representative before placing any device on the French or wider EU market. AR must be established within the EU, though not necessarily in France. Registration in any EU member state satisfies the requirement.
Under MDR Article 11(3), a written mandate between the manufacturer and the AR is not optional. It must include four things: EUDAMED registration of the manufacturer, handling communication with competent authorities, cooperating on corrective actions and reporting complaints or suspected incidents without delay.
Medical Device Regulatory Guidelines in France
The regulatory framework in France operates on two layers.
EU Layer
EU rules are directly applicable in France and do not require transposition at national level. Since 26 May 2021 the MDR (EU) 2017/745 has been fully applicable. IVDs are governed by a separate regulation, IVDR (EU) 2017/746. And for AI-based medical devices, the EU AI Act is parallel to MDR. MDCG 2025-6 is the reference document for how both regulations interact for AI-based SaMD.
French National Layer
MDR leaves certain obligations to member states, including enforcement, vigilance procedures, traceability, and language obligations. France addresses these through national law.
Ordonnance 2022-582 of 20 April 2022 updated the French Public Health Code and formally designated ANSM as the national competent authority. A further decree in April 2026 updated the national implementing rules covering device declarations and vigilance.
Medical Device Registration Process in France
Getting to market in France takes more than paperwork. Here is the step-by-step sequence manufacturers need to follow.
Step 1: Determine Device Classification
Apply the 22 classification rules under MDR Annex VIII and record the reasoning in the technical file. Borderline cases or SaMD classifications are trickier. So, consult MDCG 2021-24 or go directly to ANSM for a classification opinion. Get this confirmed before anything else.
Step 2: Appoint an EU Authorised Representative (non-EU manufacturers)
The AR must be EU-established and hold a written mandate before any submission work starts. AR details must appear on the device label and IFU.
Step 3: Establish and Certify the QMS
Structure the QMS on ISO 13485:2016. Class IIa, IIb and III manufacturers are required to submit a QMS application to a Notified Body under Annex IX. Most Class I devices self-certify. But Is, Im, and Ir subtypes still require partial Notified Body assessment.
Step 4: Prepare Technical Documentation
For Class IIa and above, technical documentation must follow MDR Annexes II and III. This covers device description, intended purpose, risk management file under ISO 14971, clinical evaluation report, usability file, and labeling.
Step 5: Conformity Assessment
Class I manufacturers self-declare conformity and affix the CE mark. Class IIa, IIb, and III devices require full Notified Body assessment under Annex IX, X, or XI depending on the route chosen. Certain Class III and IIb devices also go through the CECP expert panel process under MDR Article 54.
Step 6: Register in EUDAMED
Register as an economic operator (obtaining an SRN) and register devices with their UDI. As of 28 May 2026, Actor Registration, UDI/Device Registration, Notified Bodies and Certificates, and Market Surveillance modules are all mandatory. This is a live obligation, not a future deadline.
Step 7: ANSM National Notification
First-time placement of a Class I or custom-made device requires a declaration to ANSM under Article L.5211-3-1 of the Code de la santé publique. ANSM has confirmed that EUDAMED UDI/Device module registration generally covers this. But verify for your specific device class before relying on it.
Step 8: Designate a Materiovigilance Correspondent
Before placing any device on the French market, the manufacturer or its representative must declare a materiovigilance correspondent to ANSM. This is required under Article R.5212-5 of the Code de la santé publique, updated by Décret 2026-299. This person is the point of contact for serious incident reporting to ANSM.
Step 9: Activate Post-Market Surveillance
Implement the PMS plan including complaint handling, serious incident reporting to ANSM and PSUR maintenance on the required schedule for device class.
Need support building your technical file? Artixio’s regulatory team works with manufacturers at every stage.
Required Documents for Medical Device Registration in France
The documentation set depends on device class and conformity assessment route.
| Document | All Classes | Class IIa/IIb/III | France-Specific |
| EU Declaration of Conformity | ✔ | ✔ | – |
| Technical Documentation (MDR Annexes II &III) | ✔ | ✔ | – |
| Risk Management File (ISO 14971) | ✔ | ✔ | – |
| Clinical Evaluation Report | ✔ | ✔ | |
| QMS Documentation (ISO 13485 – aligned) | ✔ | ✔ | – |
| Labeling and IFU in French | ✔ | ✔ |
✔
(required under Article R.5211-20) |
| UDI Assignment Documentation | ✔ | ✔ | – |
| Notified Body QMS/CE certificate | Is, Im, Ir only | ✔ | – |
| PSUR (MDR Article 86) | – | ✔ | – |
|
Impart Card (MDR Article 18)
|
Must be in French
|
||
| EUDAMED Registration Confirmation | ✔ | ✔ | ✔ |
| Materiovigilance Correspondent Declaration | – | – |
✔
(Declared to ANSM) |
France QMS Requirements for Medical Devices
MDR Article 10(9) makes a documented QMS a legal requirement. The QMS must be proportionate to device risk class and kept up to date. For most companies, ISO 13485:2016 is the starting point for building a compliant quality management system. Using the harmonized version (EN ISO 13485:2016) helps demonstrate alignment with many MDR requirements. But that’s not the whole picture. UDI, PRRC and vigilance handling all get checked separately and gaps in these areas come up more often than most manufacturers expect.
Notified Body involvement for QMS assessment depends on class. Class IIa, IIb and III devices require full QMS assessment under Annex IX. Standard Class I devices self-certify the QMS with no Notified Body. But Is, Im, and Ir subtypes still need partial Notified Body assessment for their specific sterile, measuring or reprocessing aspects.
At least every five years, expect an unannounced site audit. Surveillance audits run every 12 months minimum and certification requires periodic renewal.
Medical Device Labeling & IFU Requirements in France
All labeling and IFU must be in French. No exception applies for professional audiences fluent in English.
Mandatory labeling elements under MDR Annex I, Chapter III include:
- Device name and trade name
- Manufacturer name and address
- EU AR details for non-EU manufacturers
- UDI carrier in barcode and human-readable form
- Serial or batch number
- Manufacture and expiry dates where applicable
- Medical device symbol
- Storage conditions
- Sterility indicator and method where relevant
- Single-use designation
- CE mark with the Notified Body’s four-digit number for applicable classes
Electronic IFU
Regulation (EU) 2025/1234 extended eIFU to professional-use devices, applicable from 16 July 2025. Where lay users are involved, paper IFU remains required. French-language obligations apply in both formats.
Implant Cards
Every implantable device must come with an implant card under MDR Article 18, in French for use in France. The card must carry the device name, UDI, lot and serial number, model and manufacturer details. Some exceptions include: sutures, staples, dental fillings, braces, crowns, screws, wedges, plates, wires, pins, clips and connectors. Confirm where your device sits before building the labeling pack.
Registration Timelines for Medical Devices in France
There is no official timeline MDR or ANSM guarantees for the Medical Device Approval Process in France. The ranges below reflect how the process typically runs in practice.
- Class I (non-sterile, non-measuring) – typically weeks once documentation is complete.
- Class IIa – several months for a well-prepared file, longer if documentation gaps require Notified Body queries.
- Class IIb and III – months to over a year. Complex Class III submissions regularly exceed 12 months. Limited Notified Body capacity across the EU has been added to timelines since MDR took effect.
- CECP under MDR Article 54 – applies to Class III implantable and certain Class IIb devices. When triggered, it adds significant time.
French-language labeling and translation work adds to all of the above and is frequently underestimated in project planning.
Medical Device Registration Costs in France
There is no universal government fee covering all Medical Device Registration in France activities.
Costs vary depending on:
- Device classification
- Notified Body fees
- Testing requirements
- Clinical evaluation needs
- Translation requirements
- Authorized Representative fees
- Regulatory consulting support
The cost that surprises manufacturers most is not the initial Notified Body fee. It is a recurring expense. Annual surveillance audits, PSUR updates, AR retainers, and materiovigilance upkeep continue after certification. Budgeting only for market entry creates a funding gap in year two.
Import Requirements for Medical Devices in France
Importers have specific responsibilities before placing devices on the EU market.This role is distinct from the Authorised Representative and distributor.
Importers must verify that:
- The device carries a valid CE mark
- The EU Declaration of Conformity has been drawn up
- An AR is in place for non-EU manufacturers
- Labeling is correct and the IFU is included
- A UDI has been assigned where required
Importers must keep records and cooperate with competent authorities when asked. Their name, registered trade name, and contact address must appear on the device or an accompanying document without covering the manufacturer’s labeling.
These obligations form an important part of overall Medical Device Regulatory Requirements in France.
Post-Market Surveillance Requirements in France
Every manufacturer must maintain a documented PMS plan. It covers two areas. Proactive data collection through Post-Market Clinical Follow-up and registries and Reactive surveillance through complaints, adverse events and Field Safety Corrective Actions (FSCA). All feedback findings must update the risk management file and clinical evaluation report.
Reporting by Class
- Class I – Post-Market Surveillance Report, updated when significant new information emerges
- Class IIa – PSUR under MDR Article 86, updated at least every two years
- Class IIb and III – PSUR updated at least annually
Serious Incident Reporting Timelines
Under MDR Article 87:
- Serious public health threat should be reported immediately, no later than 2 days
- Death or unanticipated serious deterioration in health should be reported within 10 days
- All other serious incidents should be reported within 15 days of becoming aware
Conclusion
France is a commercially significant market, and the Medical Device Regulatory Requirements in France sit firmly inside the EU MDR structure. CE marking, EUDAMED registration, ANSM notification, French-language labeling and IFU, and a functioning materiovigilance system all have to be in place before launch.
Requirements shift depending on device class and market strategy. Getting the documentation right from the start is harder than it looks and fixing gaps after launch costs more than getting it right before.
If you need support with medical device registration, documentation, or regulatory strategy, reach out to the experts at info@artixio.com for guidance tailored to your market entry goals.
FAQ
Q1. Does France require a separate national device approval on top of CE marking?
No. CE marking is what permits a device onto the French market. France doesn’t run a separate national approval process. But it does include some national obligations such as ANSM notification for certain device classes, French-language labeling and IFU, and a materiovigilance correspondent declaration.
Q2. Is EUDAMED registration mandatory for devices sold in France?
Yes. Four EUDAMED modules were made mandatory on 28 May 2026. They include company registration, device registration, certificates from notified bodies and market surveillance. All manufacturers, ARs and importers must register. New devices must complete UDI/Device registration before being placed on the market from that date.
Q3. What is a materiovigilance correspondent and is it required in France?
Yes, it’s required. The materiovigilance correspondent is the designated point of contact for serious incident reporting to ANSM. Manufacturers or their representatives must declare this person to ANSM under Article R.5212-5 of the Code de la santé publique before placing devices on the French market.
Q4. How long does the France Medical Device Approval Process typically take?
It depends on the device class. Class I devices with no Notified Body involvement can be ready in weeks once documentation is complete. Class IIa typically takes several months. Class IIb and III regularly exceed 12 months, particularly given current Notified Body capacity constraints. The CECP process under MDR Article 54 adds additional time for applicable Class III and IIb devices.
