Eclevar MedTech designs and runs comparator-based clinical investigations, PMCF surveys and real-world evidence studies for French LPPR listing and German benefit assessment.
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
Manufacturers rely on Eclevar for the clinical and health-economic evidence HTA bodies expect. Read all client success stories.
Reimbursement is won or lost on the evidence, and on knowing how an assessor reads it. COO Dr Mark DaCosta, a former Notified Body reviewer, and our biometry function led by Chief Data Officer Sébastien Meier Piantanida, 30 years in the field, design comparator studies mapped to CNEDiMTS and IQWiG expectations from the first protocol.
Each market has its own logic. We design the evidence to the pathway, not the other way around, so the comparator, endpoints and health-economic data are right from the first protocol.
Evidence strategy for the French PECAN early access route for therapeutic and telemonitoring digital medical devices, with real-world data to support provisional-to-permanent conversion.
Evidence strategy for the German DiGA fast track, listed by BfArM under the Digital Healthcare Act, including the real-world data that converts a provisional listing into a permanent one.
| Reactive approach | Eclevar + Milo |
|---|---|
| Comparator chosen late. | Comparator and endpoints mapped early to CNEDiMTS and IQWiG. |
| No health-economic endpoints. | Health-economic data embedded in the protocol. |
| Low clinical added value rated. | Strong ASA grades and a sufficient-benefit pathway. |
| NUB and 137h requirements discovered post-launch. | Pathway requirements mapped upfront. |
| No real-world evidence plan. | PMCF and RWE planned for post-listing. |
| Separate vendors. | One in-house team, protocol to listing. |
A multi-centre reimbursement clinical study generating the evidence required for market and payer access.
Market and payer evidence.PMCF and real-world evidence for regenerative wound-care devices, supporting both Notified Body scrutiny and reimbursement endpoints.
PMCF & RWE, 160 patients.Restructuring Japanese clinical documentation into the rigour European reviewers and payers expect.
Documentation for review.Whitepapers, client testimonials and publications produced by our teams and partners (BSI, TÜV SÜD, RegenLab).
Written with Notified Body BSI: a practical reading of the clinical evidence expectations under EU MDR 2017/745, the same evidence that underpins a reimbursement case.
Eclevar manages RegenLab's PMCF programme on chronic wound devices. 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 both Notified Body scrutiny and reimbursement endpoints, from protocol design through to final study report.
« Eclevar, with its tailor-made approach and advanced Milo Studio platform, represents a major strategic asset. »
The CNEDiMTS commission at HAS first rules on the clinical benefit (Service Attendu), which must be sufficient for a device to reach the LPPR. It then grades the clinical added value (ASA) from I to V, which drives CEPS pricing and LPPR listing.
The LPPR is the French List of Reimbursable Products and Services. Listing follows a clinical assessment by HAS and CNEDiMTS. Only devices judged to have a sufficient clinical benefit are eligible.
The G-BA is the central decision body, IQWiG appraises the evidence and InEK manages the DRG system. For new hospital methods, a NUB application to InEK can open temporary reimbursement while evidence is collected, and high-risk device methods trigger early benefit assessment under Section 137h.
PECAN is the French early access scheme for therapeutic and telemonitoring digital medical devices. DiGA is the German fast track for digital health applications, listed by BfArM under the Digital Healthcare Act, with a provisional listing that can convert to permanent.
Yes. Eclevar designs and runs the comparator-based clinical investigations, PMCF surveys and real-world evidence studies that French and German HTA bodies expect.
Timelines depend on the device, the evidence and the pathway, and some steps are deadline-bound, such as Section 137h and the annual NUB cycle. Early access schemes like PECAN and DiGA can bridge the gap while evidence is generated.
Tell us about your device and target markets. We will map the evidence to the French and German pathways and give you a clear, costed plan before you commit.
Book a reimbursement scoping call