France is Europe's second-largest medtech market, and it is largely publicly funded. We run your EU MDR clinical investigation through the ANSM and the CPP ethics committees, then design the same evidence to answer CNEDiMTS at the reimbursement gate, so regulatory success turns into real patient access.
Platinum Award 2026
Top prize in the xShare x European CRO Federation "EHDS & Clinical Research" Open Call, awarded to Eclevar MedTech and its Milo Health platform, presented at the EUCROF 2026 conference in Amsterdam.
Horizon Europe · Grant Agreement No. 101136734 · Amsterdam, 2 Feb 2026
Device leaders rely on Eclevar to reach the French and EU markets. Read all client success stories.
Dr Mark DaCosta, COO and former TÜV SÜD reviewer, leads a team that reads Notified Body and CNEDiMTS requirements as one aligned problem. We design a clinical investigation and PMCF programme that supports an EU MDR file for CE marking and a reimbursement dossier at the same time, with in-house French CRAs across the university-hospital network rather than outsourced monitoring.
Evidence that satisfies Notified Bodies for CE marking differs from what CNEDiMTS needs for reimbursement. Comparators, endpoints and target populations can diverge. A fragmented approach generates one dataset for CE marking, then finds reimbursement asks for something else. We keep both aligned with your EU MDR regulatory strategy from the protocol stage.
A device that secures CE marking but arrives at the reimbursement gate without comparative, benefit-focused evidence meets a French market that is largely publicly funded, and therefore largely closed until reimbursement is settled.
Deciding at the outset whether reimbursed access is intended shapes study design fundamentally. France offers early engagement with regulatory and reimbursement authorities, so sponsors design studies that answer the real questions.
Built once, your Clinical Evaluation Report and investigation serve both the CE-marking file and the reimbursement dossier, avoiding duplicate studies after close.
Since May 2021, France fully applies EU MDR for clinical investigations. An Article 62 investigation needs authorisation from the ANSM and a favourable opinion from a Comité de Protection des Personnes, both submitted together under the national procedure. See our MDR technical review and regulatory services.
Reimbursement profoundly shapes commercial outcomes in France. Building comparative, benefit-focused evidence during trial design, not after close, converts regulatory success into actual patient access. This is where real-world evidence and PMCF feed the reimbursement story.
CNEDiMTS typically expects a clinically relevant comparator. A single-arm study that is sufficient for CE marking may not support a reimbursement claim.
Benefit and quality-of-life endpoints that match reimbursement priorities, alongside the safety and performance endpoints Notified Bodies require.
A study population that reflects the intended reimbursed indication, not only the CE-mark claim, so the data speaks to the population that matters commercially.
Reimbursement evidence built into the pivotal study through your PMCF plan, rather than a separate post-CE study.
For implantable devices, the ANSM recommends seeking scientific advice through its innovation and orientation desk 6 to 12 months before submission. This surfaces pre-clinical and design expectations early and smooths the later review, a step non-French sponsors frequently underuse.
Running ANSM and CPP submissions as routine, managing French-language dossiers in-house and holding relationships across the French hospital network is hard to assemble from outside France.
Standing relationships across the French university-hospital network, so feasibility and site selection start from real, contactable sites.
In-house French CRAs run site initiation and on-site and remote monitoring under EU MDR, rather than outsourced monitoring.
Evidence shaped for both Notified Bodies and CNEDiMTS from the protocol stage, on the MILO Studio platform for prospective data capture.
Confirm CE and reimbursement intent, comparators, endpoints and population.
Prepare the French dossier and submit ANSM and CPP in parallel.
Feasibility and initiation across the university-hospital network.
In-house French CRAs on MILO Studio, on-site and remote.
One evidence base feeds the CE file and the reimbursement dossier.
The ANSM is the French competent authority and must authorise a clinical investigation, alongside a favourable opinion from a Comité de Protection des Personnes (CPP), the ethics committee. Both are submitted together under the national procedure. Since May 2021, France applies EU MDR 2017/745 for medical device clinical investigations.
Often yes, if it is designed for both from the start. The comparators, endpoints and populations that satisfy CNEDiMTS for reimbursement can differ from the minimum a Notified Body needs for CE marking, so planning for both avoids generating duplicate evidence after the trial has closed.
Yes. Key documents, including a summary of the clinical investigation plan, must be provided in French. As a France-based CRO, Eclevar prepares and manages these French-language requirements in-house.
For implantable devices, the ANSM recommends seeking scientific advice through its innovation and orientation desk 6 to 12 months before submission. This surfaces pre-clinical and design expectations early and smooths the later review, a step non-French sponsors frequently underuse.
Yes. Eclevar deploys in-house French CRAs, so ANSM and CPP submissions, French-language dossiers, site initiation and monitoring across the French university-hospital network are handled by our own team rather than outsourced.
We run medical device investigations in France with in-house CRAs, access to French investigator sites across major therapeutic areas, and a direct reading of the national pathway: ANSM authorisation, CPP ethics review and the CNEDiMTS / HAS route for reimbursement evidence.
Our team manages protocols, French-language documentation, site contracts and monitoring locally, so sponsors targeting the French market build MDR evidence and market-access evidence in a single, coordinated programme.
"This is a randomized study of 160 patients across 14 sites in 5 EU countries, covering both diabetic foot ulcer (DFU) and venous leg ulcer (VLU) indications. The partnership combines Eclevar's ISO 14155 clinical expertise with the Milo Studio platform to deliver post-market clinical follow-up evidence that supports the CE marking."
Antoine Turzi, CEO, RegenLab · 160 patients · 14 sites · 5 EU countries
Talk to our team about your device, your ANSM and CPP route and how to design one evidence base for both CE marking and CNEDiMTS reimbursement.
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