France Medical Device Reimbursement Overview
French Medical Device Reimbursement Landscape & Decision Makers
To achieve market access in France, manufacturers must navigate a complex ecosystem of coding and funding. For 2026, we provide strategic clarity on:
- Coding Systems: Mapping your device to CCAM v.81 (professional acts), LPPR (individual-use devices), or the NABM (IVD tests).
- Market Access Pathways: Determining eligibility for the PECAN fast-track for digital health or the "Liste en Sus" for high-cost hospital innovations.
- Decision Makers: Defining the specific roles of HAS (evaluation), CNEDiMTS (clinical benefit), and CEPS (pricing negotiations).
Evidence Requirements: Secure Optimal ASA and SA Grades
Clinical evidence is the foundation of French reimbursement. We help you generate the necessary data to secure a high ASA (Amélioration du Service Attendu) grade and comply with 2026 mandates:
- Clinical Strategy: Adjusting study protocols to meet the randomized controlled trial (RCT) expectations of the CNEDiMTS.
- Real-World Evidence (RWE): Designing the mandatory post-market data collection protocols now required for LPPR renewals and long-term market access.
- Medico-Economic Modeling: Required by the CEESP for devices with significant budget impacts or claims of organizational efficiency.
- ASA/SA Dossier Preparation: Crafting the technical submission that justifies your device's clinical benefit (SA) and its improvement over existing standards (ASA).
Market Access Execution & PECAN Implementation
From the initial submission to the first reimbursed sale, we manage every phase of your French market entry:
- PECAN Applications: Guiding digital medical devices (DMN) through the two-month fast-track for immediate 12-month coverage.
- LPPR Inclusion: Managing the administrative and clinical hurdles for listing on the Liste des Produits et Prestations Remboursables.
- Hospital GHS/GHS Funding: Securing "intra-GHS" or "add-on" funding via the Liste en Sus mechanism for innovative devices used in inpatient settings.
- Billing Guides: Developing technical documentation for clinicians to ensure correct billing of your device via CCAM v.81 and NABM codes.
France Reimbursement FAQs (2026 Update)
What is the PECAN pathway in France?
PECAN is a 12-month non-renewable early reimbursement pathway for digital medical devices (DMN). As of 2026, it is a critical entry point for Class IIb and III therapeutic software, allowing manufacturers to generate Real-World Evidence (RWE) while being paid.
How long does medical device reimbursement take in France?
Standard HAS evaluation and CEPS price setting takes 12–24 months. Fast-track pathways like PECAN provide coverage in roughly 90 days, while the "Liste en Sus" (Title V of LPPR) offers a pathway for expensive hospital consumables to bypass standard DRG (GHS) bundle limitations.
What is the significance of the CCAM v.81?
Released for 2026, CCAM v.81 includes new codes for MR-guided ultrasound, robotic-assisted surgery, and cardiovascular interventions. Ensuring your device is linked to the correct, updated procedure code is essential for provider adoption.
What is the importance of the ASA grade?
The ASA (Added Clinical Value) grade ranges from I to V. Grades I-III allow for significant pricing flexibility and premiums, while Grade V typically results in a price that must match the lowest existing comparator.
Why Mediclever for Medical Device Reimbursement in France?
Mediclever is a specialized reimbursement consultancy supporting medical device manufacturers with 2026-compliant evidence generation, pricing strategy, and market access execution. Our team provides direct expertise in navigating the HAS, CNEDiMTS, and CEPS negotiations to ensure your technology reaches French patients faster.