France Medical Device Registration & Market Access Guide (2026): ANSM, CE Marking, LPPR Reimbursement & Requirements
Everything you need to know about marketing medical devices in France in 2026 — including EU MDR requirements, ANSM registration, EUDAMED deadlines, French-language labeling mandates, CNEDiMTS and CEPS reimbursement pathway, LPPR listing, clinical investigation procedures, materiovigilance obligations, and practical market entry guidance for Europe's second-largest medical device market.
Overview of France's Medical Device Market
France is the second-largest medical device market in Europe (behind Germany) and one of the top five globally. The French medical devices market was valued at approximately $25.15 billion in 2025 and is projected to grow to $36.94 billion by 2032, at a CAGR of approximately 5.6%. France's universal healthcare system (Assurance Maladie) is one of the most generous in the world, with healthcare spending representing approximately 11.5% of GDP — among the highest in the OECD.
The French medical device ecosystem includes a strong domestic manufacturing base alongside significant import dependency, with over 1,300 medical device companies operating in the country. France is particularly strong in orthopedics, cardiovascular devices, diagnostic imaging, minimally invasive surgical technologies, and digital health (Software as a Medical Device). Public hospital procurement accounts for the majority of device spending, with the country's 298 public hospital centers (CHU/CH) and extensive network of private clinics providing broad market access.
France is not just a consumer market — it is a strategic launch market for European market access. Successful reimbursement through the French LPPR (Liste des Produits et Prestations Remboursables) can serve as a reference for pricing negotiations across Southern Europe and beyond.
Key Market Data
| Metric | Value |
|---|---|
| Total market size (2025) | $25.15 billion (~€23.2 billion) |
| Projected market (2032) | $36.94 billion |
| CAGR (2025–2032) | 5.6% |
| Healthcare spending as % of GDP | ~11.5% |
| Number of companies | 1,300+ |
| Public hospital centers | 298 (including 32 university hospitals) |
| Population | ~68 million |
Regulatory Framework
As an EU member state, France does not have a standalone national approval system for medical devices. Devices are regulated primarily under EU-wide legislation, supplemented by national implementing laws and French-specific requirements.
EU-Level Legislation
| Regulation | Purpose |
|---|---|
| Regulation (EU) 2017/745 (MDR) | Primary legislation for medical devices — classification, conformity assessment, CE marking, clinical evidence, post-market surveillance |
| Regulation (EU) 2017/746 (IVDR) | Primary legislation for in vitro diagnostic devices |
| Commission Implementing Decision (EU) 2025/2371 | Declares EUDAMED mandatory from 28 May 2026 |
National Legislation
| Law | Purpose |
|---|---|
| Code de la santé publique (CSP) | French Public Health Code — transposes MDR/IVDR into national law, including Articles L.5211-1 et seq. for medical devices |
| Ordonnance n° 2022-582 | Adopted 20 April 2022, implementing MDR into French law |
| Code de la sécurité sociale | Social Security Code — governs reimbursement of medical devices through the LPPR |
| Code de la propriété intellectuelle | Intellectual Property Code — trademark and patent provisions affecting medical devices |
| Décret n° 2023-1168 | National decree addressing medical device advertising and materiovigilance |
Key Regulatory Authorities
| Authority | Role |
|---|---|
| ANSM (Agence nationale de sécurité du médicament et des produits de santé) | National Agency for Medicines and Health Products Safety — primary competent authority for medical devices in France |
| HAS (Haute Autorité de Santé) | National Authority for Health — evaluates clinical value of medical devices through CNEDiMTS for reimbursement decisions |
| CNEDiMTS (Commission nationale d'évaluation des dispositifs médicaux et des technologies de santé) | National Commission for Evaluation of Medical Devices and Health Technologies — assesses clinical benefit (SA) and added value (ASA) for LPPR listing |
| CEPS (Comité économique des produits de santé) | Healthcare Products Pricing Committee — negotiates prices for reimbursable medical devices |
| ANS (Agence du numérique en santé) | National Digital Health Agency — oversees digital health infrastructure, including EUDAMED coordination |
CE Marking and Market Access
All medical devices placed on the French market must bear the CE mark in accordance with the EU MDR. There is no separate "French approval" — CE marking is the gateway, but France imposes additional national registration and notification requirements.
Steps to Market Access in France
Step 1: Classification (MDR Annex VIII)
- Classify your device under MDR rules (Class I, IIa, IIb, III)
- Classification is based on intended purpose, duration of contact, invasiveness, and active nature
Step 2: Conformity Assessment
- Class I (non-sterile, non-measuring, non-reusable surgical): Self-declaration by the manufacturer
- Class Is, Im, Ir, IIa, IIb, III: Involvement of a Notified Body is mandatory
- The Notified Body assesses your quality management system and technical documentation
Step 3: Technical Documentation
- Prepare a complete technical file in accordance with MDR Annexes II and III
- Include clinical evaluation, risk management, labeling, and instructions for use
Step 4: Declaration of Conformity and CE Marking
- Issue the EU Declaration of Conformity
- Affix the CE mark to the device and packaging
- Include the Notified Body number (for Class Is and above)
Step 5: ANSM Notification
- Submit a notification to ANSM before placing the device on the French market
- Notification can be submitted by the manufacturer, Authorized Representative, or distributor
- ANSM has announced that EUDAMED registration can fulfill the national notification requirement
Step 6: Appoint Authorized Representative (if non-EU)
- Manufacturers outside the EU must appoint an EU Authorized Representative
- The AR must be identified on labeling and registered in EUDAMED with an SRN
EUDAMED Registration
Under Commission Implementing Decision (EU) 2025/2371, the first four EUDAMED modules become mandatory on 28 May 2026. This is the most significant regulatory change for French market access in 2026.
EUDAMED Modules and Deadlines
| Module | Content | Mandatory From |
|---|---|---|
| Actors | Registration of manufacturers, ARs, importers, sponsors | 28 May 2026 |
| UDI/Devices | Device registration with UDI data | 28 May 2026 |
| NB/Certificates | Notified Body certificate registration | 28 May 2026 |
| Market Surveillance | National authority market surveillance data | 28 May 2026 |
| Clinical Investigations | Under development | TBD |
| Vigilance | Under development | TBD |
Key Deadlines for France
| Deadline | Requirement |
|---|---|
| 28 May 2026 | All economic operators must be registered as Actors in EUDAMED. New MDR/IVDR devices must be registered in UDI/Devices before being placed on the French market |
| 28 November 2026 | Legacy devices and devices already on the market before 28 May 2026 must be registered in EUDAMED |
| 28 May 2027 | Notified Bodies must register all MDR/IVDR certificates issued before the mandatory use date |
Important: ANSM has announced that devices registered in EUDAMED satisfy the French national notification requirement. However, ANSM reserves the right to audit devices to confirm accuracy of submitted information.
ANSM National Registration
In addition to EU-wide EUDAMED requirements, France maintains a national notification obligation administered by ANSM.
ANSM Notification Process
- Prepare documentation: Application form, label, French IFU, CE certificate, Declaration of Conformity, Certificate of Incorporation
- Submit notification: Via email to ANSM (or via EUDAMED registration, which ANSM now accepts as equivalent)
- Timeline: 2–4 weeks for complete submissions
- No fee: ANSM does not charge for the notification
- Commercialization: Can begin as soon as the notification is submitted
Activity Declaration
Manufacturers and distributors must declare their activity to ANSM. This includes:
- Registering as a manufacturer, distributor, or importer
- Declaring a materiovigilance correspondent (responsible for post-market surveillance reporting)
- Registering the placement of medical devices on the market
IVD-Specific Requirements
For in vitro diagnostic devices, manufacturers must register in the SIDIV (Système d'Information des Dispositifs In Vitro) database, France's national IVD registry maintained by ANSM.
French-Specific Requirements
While most medical device requirements in France derive from the EU MDR, several national provisions impose additional obligations beyond the EU baseline.
1. French-Language Labeling and Documentation
France mandates that all labeling, instructions for use (IFU), and safety information be provided in French. This requirement is enshrined in the Loi Toubon (French Language Law of 1994) and the Public Health Code. ANSM enforces this strictly — even for devices intended exclusively for specialist physicians who may be proficient in English, French-language documentation is non-negotiable. Non-compliance can result in administrative fines of up to €150,000 and product withdrawal.
- Labels and packaging: Must be in French
- Instructions for Use (IFU): Must be provided in French
- Technical documentation: May be submitted in English
- Promotional materials: Must be in French and may require ANSM authorization
2. Advertising Authorization
Advertising of medical devices to healthcare professionals in France requires ANSM authorization for devices listed as posing a significant health risk. For devices eligible for reimbursement, advertising must be submitted during designated filing periods:
- Visa PM (for healthcare professionals): Four filing periods per year in 2026
- Visa GP (for the general public): Eight filing periods per year in 2026
Advertising visas are granted for five years, provided the CE marking remains valid.
3. Compassionate Use and Derogations
ANSM can grant a derogation authorizing the use of a medical device that is not CE marked in the absence of an alternative on the French market, provided that the benefit for the patient is significant. This pathway is rarely used but provides an important mechanism for patients with unmet needs.
4. Materiovigilance (Post-Market Surveillance)
France operates a materiovigilance system requiring manufacturers, distributors, and users to report serious incidents and field safety corrective actions to ANSM. Key obligations include:
- Materiovigilance correspondent: Must be designated and registered with ANSM
- Serious incident reporting: Within timelines specified by MDR Articles 87–89
- Field Safety Corrective Actions (FSCAs): Must be reported before or at the time of implementation
- Periodic Safety Update Reports (PSURs): Required under MDR Article 86 for higher-class devices
Forfait Innovation: Accelerated Reimbursement for Breakthrough Devices
In 2026, the French government has reinforced the Forfait Innovation (Innovation Package) pathway — a mechanism allowing innovative medical devices to obtain 2–3 years of reimbursement before completing large-scale clinical benefit validation. This is particularly relevant for AI-powered diagnostics, digital therapeutics, and breakthrough technologies.
How It Works
- Eligibility: The device must demonstrate significant innovation and potential clinical added value (ASA I or II)
- Application: Submitted simultaneously to HAS (CNEDiMTS evaluation) and CEPS (pricing)
- Evidence generation: During the 2–3 year reimbursement period, the manufacturer must collect real-world evidence (RWE) in French hospitals
- Transition to LPPR: The RWE data serves as the basis for final LPPR listing evaluation
This pathway is particularly important for manufacturers of AI-enabled devices and digital health products seeking rapid market access with reimbursement in France.
Reimbursement: The LPPR Pathway
For manufacturers seeking reimbursement through the French national health insurance system, inclusion on the LPPR (Liste des Produits et Prestations Remboursables — List of Reimbursable Products and Services) is essential. This is a multi-step process involving clinical evaluation by HAS and price negotiation with CEPS.
Step 1: CNEDiMTS Clinical Evaluation
The CNEDiMTS evaluates the clinical value of the device through a two-step assessment:
- Service Attendu (SA) — Clinical Benefit: Assessed as either "sufficient" or "insufficient." Only devices with sufficient clinical benefit proceed.
- Amélioration du Service Attendu (ASA) — Clinical Added Value: Graded on a scale from I (major improvement) to V (no improvement). The ASA level directly influences pricing:
- ASA I: Major improvement — favorable pricing conditions
- ASA II: Significant improvement
- ASA III: Moderate improvement
- ASA IV: Minor improvement
- ASA V: No improvement — price aligned with existing alternatives
Step 2: CEPS Price Negotiation
If CNEDiMTS issues a favorable opinion, the CEPS (Healthcare Products Pricing Committee) negotiates the price. CEPS considers:
- Comparative prices of similar devices already on the LPPR
- ASA level assigned by CNEDiMTS
- Expected volume of use and budget impact
- Prices in other EU member states (external reference pricing)
Step 3: Ministerial Order
Pricing and reimbursement decisions are formalized through a Ministerial Order issued jointly by the Ministers of Health and Social Security.
Liste en Sus: Hospital Add-On Reimbursement
For innovative devices used in hospitals, the liste en sus (add-on list) provides a mechanism for separate reimbursement outside the standard hospital stay package (GHS — Groupe Homogène de Séjours). This is particularly important for expensive implantable devices and innovative technologies.
To qualify for liste en sus:
- The device must demonstrate clinical benefit evaluated by CNEDiMTS
- ASA level I or II is typically required for favorable decisions
- The manufacturer submits a technical dossier to HAS
Only a small percentage of new products receive ASA level I or II each year, making the liste en sus a competitive pathway.
Fees and Costs
France does not charge a separate registration fee for the ANSM notification. However, the overall cost of market entry includes EU-wide conformity assessment costs and French-specific expenses:
| Item | Estimated Cost |
|---|---|
| ANSM notification | No fee |
| EUDAMED registration | No fee (EU system) |
| Notified Body assessment (Class IIa–III) | €15,000–€100,000+ depending on device class and complexity |
| French-language translation (labeling/IFU) | €2,000–€25,000 depending on device complexity |
| EU Authorized Representative (for non-EU manufacturers) | €3,000–€15,000/year |
| Advertising visa application (ANSM) | No separate fee, but preparation costs apply |
| LPPR reimbursement dossier | €50,000–€200,000+ (clinical evidence, economic dossier, consultants) |
| Clinical investigation in France | No ANSM application fee; study costs vary widely |
Total Estimated Cost to Market in France (CE Marking Included)
| Route | Estimated Total Cost |
|---|---|
| Class I (self-declaration) | €5,000–€20,000 (documentation, translations, AR) |
| Class IIa (via Notified Body) | €20,000–€65,000 (NB fees + documentation + translations + AR) |
| Class IIb/III (via Notified Body) | €50,000–€200,000+ (NB fees + clinical data + documentation + translations + AR) |
| With LPPR reimbursement | Additional €50,000–€200,000+ on top of CE marking costs |
Timelines
| Step | Timeline |
|---|---|
| CE marking (Class I, self-declaration) | 1–3 months (documentation preparation) |
| CE marking (Class IIa, via NB) | 6–12 months |
| CE marking (Class IIb/III, via NB) | 12–24+ months |
| ANSM notification | 2–4 weeks |
| EUDAMED Actor registration | 1–4 weeks |
| EUDAMED Device registration | 1–4 weeks per device |
| LPPR dossier (CNEDiMTS evaluation) | 6–12 months from submission |
| CEPS price negotiation | 3–6 months after CNEDiMTS opinion |
| Total LPPR process | 12–18 months from initial dossier submission |
| Advertising visa | Variable (submitted during designated filing periods) |
Practical Tips
Register in EUDAMED immediately: The 28 May 2026 deadline is firm. ANSM accepts EUDAMED registration as fulfilling the national notification, so completing EUDAMED registration covers both requirements simultaneously.
Plan for French translations early: French-language IFU and labeling are mandatory and must be completed before market entry. Budget adequate time and resources for professional translation.
Align regulatory and reimbursement strategies: If you intend to seek LPPR reimbursement, begin clinical evidence planning during the CE marking process. The CNEDiMTS evaluation requires robust clinical data, and early engagement with HAS through early dialogue procedures can save significant time.
Understand the liste en sus opportunity: For innovative hospital devices, the liste en sus pathway can provide faster reimbursement than full LPPR listing. However, competition is intense, and only devices with strong clinical evidence (ASA I or II) are successful.
Designate a materiovigilance correspondent: This is a French-specific requirement. Your correspondent must be registered with ANSM before placing devices on the market.
Monitor MDR simplification discussions: The European Commission is considering MDR simplification measures in 2026. France has been an active participant in these discussions, and any changes could affect compliance obligations.
Key Contacts and Resources
| Resource | URL/Contact |
|---|---|
| ANSM (regulatory authority) | ansm.sante.fr |
| HAS (health technology assessment) | has-sante.fr |
| EUDAMED (EU device database) | ec.europa.eu/tools/eudamed |
| CNEDiMTS (device evaluation) | has-sante.fr (via HAS) |
| CEPS (pricing committee) | solidarity-sante.gouv.fr |
Summary Checklist for Market Entry in France
- Classify device under MDR (Class I, IIa, IIb, III)
- Complete conformity assessment (self-declaration or via Notified Body)
- Prepare technical documentation (MDR Annexes II & III)
- Issue Declaration of Conformity and affix CE mark
- Translate labeling and IFU into French
- Appoint EU Authorized Representative (if non-EU)
- Register as Actor in EUDAMED (obtain SRN)
- Register device in EUDAMED UDI/Devices module
- Submit ANSM notification (or confirm EUDAMED registration satisfies requirement)
- Declare activity to ANSM and designate materiovigilance correspondent
- (If applicable) Submit LPPR reimbursement dossier to HAS/CNEDiMTS
- (If applicable) Apply for advertising visa from ANSM
- Implement post-market surveillance and materiovigilance procedures