Reimbursement in France: LPPR, HAS and CNEDiMTS
Comparator based clinical and PMCF evidence designed for CNEDiMTS, built to support a sufficient Service Attendu and a strong ASA grade for LPPR and Intra GHS listing.
See the France pathway
Platinum Award · xShare & EUCROF 2026
Medical device reimbursement in France and Germany, built on the evidence HTA bodies expect.
Reimbursement in France and Germany is won on clinical evidence, not paperwork. Eclevar MedTech designs and runs the comparator based clinical investigations, PMCF surveys and real world evidence studies behind French LPPR listing (HAS, CNEDiMTS) and German benefit assessment (G-BA, IQWiG, NUB and 137h), captured in our Milo EDC platform.
2
Core markets, France and Germany
6+
EU countries with in-country teams
2
Digital fast tracks: PECAN and DiGA
160
Countries reached via partners
Evidence aligned with
EU MDR 2017/745
ISO 14155:2020
HAS & CNEDiMTS
G-BA & IQWiG
GDPR
Where you are in the journey
Whatever you searched for, this is the medical device reimbursement partner for it.
Three of the most common reasons MedTech sponsors come to Eclevar for France and Germany. Pick the one that matches your device.
Reimbursement in Germany: G-BA, NUB and 137h
Evidence and study design for NUB applications to InEK and for the Section 137h early benefit assessment of high risk device methods, appraised by IQWiG for the G-BA.
See the Germany pathwayDigital health fast track: PECAN and DiGA
Evidence strategy for the French PECAN early access route and the German DiGA fast track, including the real world data that turns a provisional listing into a permanent one.
How fast tracks work
MedTech manufacturers that trust Eclevar
SHOFU
Meril
NIHON KOHDEN
regenlab
UNITHER
GENTELL
Client evidence programmes
Evidence built for payers, run by our in-house team.
From a multi center reimbursement trial to real world evidence across 160 countries, here is how Eclevar generates the data health systems ask for.
Real world evidence · Strategic alliance · Wound care
RegenLab
Eclevar manages all upcoming PMCF studies on chronic diabetic foot ulcer devices for RegenLab, a Swiss regenerative-medicine manufacturer present in 160 countries. Real world evidence at this scale is exactly what payers and HTA bodies look for.
Eclevar, with its tailor made approach and advanced Milo Studio platform, represents a major strategic asset. Antoine Turzi, CEO, RegenLab
Reimbursement · United Kingdom
Meril Life Sciences
A multi center reimbursement clinical trial in the UK, designed from the start to generate the comparator and outcome evidence that payers and health systems require.
Neuro · Japan to EU MDR
Nihon Kohden
Restructured Japanese clinical documentation logic into the language and rigor European reviewers expect, for a Class IIa EEG device.
Eclevar shared their expertise in a way that allowed us to create documentation perfectly adapted to our needs. Product Manager, Nihon Kohden
Dental devices
Shofu Inc.
Clinical evaluation and post-market evidence generation for advanced dental and restorative technologies under EU MDR.
How reimbursement works
Two markets, two routes, one evidence strategy.
France and Germany reward the same thing: comparator based clinical and real world evidence, planned early. The pathways differ in the details.
France: the LPPR pathway
1. Clinical benefit, Service Attendu. CNEDiMTS at HAS judges the actual benefit as sufficient or insufficient. Only a sufficient benefit opens the door to the LPPR.
2. Clinical added value, ASA. The added value is graded from I, major, to V, absent. A higher grade gives you real leverage on price.
3. Price and listing. Pricing is set with the CEPS, then an order in the Journal Officiel lists the device on the LPPR, for individual use or hospital add on reimbursement and the Intra GHS list.
Digital and early access. PECAN provides early access for therapeutic and telemonitoring digital medical devices, alongside the French innovation pathways for novel technologies.
Germany: the G-BA pathway
1. NUB application to InEK. For new hospital methods, a NUB application can open temporary reimbursement while evidence is collected, with an annual submission cycle.
2. Section 137h assessment. Methods based on high risk devices trigger an early benefit assessment by the G-BA, with the evidence appraised by IQWiG.
3. Testing study and integration. The G-BA may decide on a testing study, and a positive route leads to integration into the DRG system, often with a supplementary payment.
Digital fast track. DiGA lets digital health applications be listed by BfArM under the Digital Healthcare Act, with a provisional listing while evidence of a positive care effect is generated.
Pathways summarised for orientation. Eclevar maps the exact requirements for your device class and indication.
Therapeutic franchises
Specialist evidence across five device areas.
HTA bodies expect comparators and endpoints that fit the specialty. Dedicated medical and clinical leads make sure yours do.
Cardiology & structural heart
High-risk and Class III cardiovascular devices.
Orthopedics & spine
Implants, PMCF and clinical evaluation reports.
Dental devices
Restorative and dental technology evidence.
Neuromodulation & neuro-implants
Neuro devices from feasibility to PMCF.
Advanced wound care
Tissue engineering and regenerative devices.
Reactive reimbursement vs evidence led market access
Plan the evidence early, or discover the gap too late.
Most reimbursement problems are evidence problems, decided long before the dossier is written. Our model fixes that from day one.
Reactive approach
Evidence that was built for CE marking only
- Comparator chosen late, after the trial design is fixed
- No health-economic endpoints in the protocol
- Clinical added value rated low, or benefit judged insufficient
- NUB and 137h requirements discovered after launch
- No real world evidence plan for post-listing
- Separate vendors for clinical, data and market access
vs
Eclevar + Milo
Evidence designed for HTA from day one
- Comparator and endpoints mapped to CNEDiMTS and IQWiG early
- Health-economic data embedded in the study, not bolted on
- PMCF and real world evidence planned for post-listing
- Pathway requirements for LPPR, NUB and 137h mapped up front
- Milo EDC capturing payer grade, inspection ready data
- One in-house team for clinical, biometry and evidence strategy
Leadership
Experts who know how evidence is read.
Former Notified Body reviewers, biometricians and clinical operators who understand exactly how reviewers and payers will read your data.
Our mission is to bridge the gap between operational reality and Notified Body requirements. Chems Hachani, Founder & CEO
Prof. Mark DaCosta
CMO & Cardiovascular
Leads regulatory strategy for high-risk and Class III devices, with first-hand experience of Notified Body question cycles.
Dr. Nikhil Khadabadi
CMO & Orthopedics
Former senior reviewer at TUV SUD. Builds PMCF programmes and CERs to the standard he applied as a reviewer of Class III implants.
Pierre-Marie Boutanquoi
Head of CER
Clinical evaluation methodology for cardiovascular devices and complex implants, traceability matrices and Article 61(4) equivalence.
S. Meier Piantanida
Chief Data Officer
30 years in biometry and lead architect of the Milo EDC platform, with deep 21 CFR Part 11 and inspection-readiness experience.
Nancy Boodhun
Director of Operations
Runs site qualification and ISO 14155:2020 compliant clinical operations across European study sites.
Karina
Clinical Project Management
Coordinates clinical study delivery and sponsor communication across Eclevar's European programmes.
Where we operate
Offices in France and Germany, evidence across Europe.
Reimbursement evidence is local. We run it with in-country teams in the two markets at the centre of this page, France and Germany, plus active delivery in the United Kingdom and a wider European network. Beyond Europe, dedicated regulatory corridors connect your device to Japan, India and the United States, and a partner network extends reach to 160 countries.
Japan corridor · PMDA
India corridor · CDSCO
US corridor · FDA
🇫🇷FranceHQ Paris
🇩🇪GermanyErfurt
🇬🇧United KingdomActive
🇮🇹ItalyIn-country
🇪🇸SpainIn-country
🇸🇪SwedenIn-country
🇩🇰DenmarkIn-country
🇯🇵JapanPMDA
FAQ
Reimbursement in France and Germany, explained.
How does medical device reimbursement work in France?+
France uses a national HTA pathway. 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 informs price negotiation with the CEPS before listing on the LPPR is confirmed by an order in the Journal Officiel.
What is the LPPR and how do I get a device listed?+
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, and the clinical added value grade influences pricing. Devices can be reimbursed for individual use or, in hospitals, through add on reimbursement and the Intra GHS pathway.
How does medical device reimbursement work in Germany?+
In Germany 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. Methods based on high risk devices trigger an early benefit assessment under Section 137h SGB V, which can lead to a G-BA testing study and integration into the DRG system.
What are PECAN and DiGA?+
PECAN is the French early access scheme for therapeutic and telemonitoring digital medical devices, with evaluation principles published by HAS. DiGA is the German fast track for digital health applications, listed by BfArM under the Digital Healthcare Act, with a provisional listing that allows reimbursement while evidence of a positive care effect is generated.
Do you run reimbursement and market access clinical studies?+
Yes. Eclevar designs and runs the comparator based clinical investigations, PMCF surveys and real world evidence studies that French and German bodies expect, captured in the Milo EDC platform. For example, we ran a multi center reimbursement trial for Meril Life Sciences in the United Kingdom, built to generate the evidence payers and health systems require.
How long does reimbursement take in France and Germany?+
Timelines depend on the device, the evidence available and the pathway. Some steps are deadline bound, such as the German Section 137h assessment and the annual NUB cycle, and early access schemes like PECAN and the German DiGA provisional listing exist to bridge the gap while evidence is generated. The strongest lever on timing is planning evidence early, with the right comparator and endpoints.
Plan your France and Germany reimbursement evidence with Eclevar.
Send us your device and target indication. We come back with a costed, dated plan for an HTA ready clinical, PMCF or real world evidence study, mapped to the LPPR and German benefit assessment.
Book a reimbursement scoping call