Market access · Reimbursement · 2026
Medical device reimbursement in Europe, country by country.
CE marking opens the European market. Reimbursement decides whether your device is used. France, Germany, the UK and Italy each run independent systems, with distinct bodies, evidence and timelines.
European Champion
Platinum Award 2026
Eclevar MedTech & Milo Health · xShare × EUCROF Open Call
Led by authority
Reimbursement strategy from people who build the evidence.
Reimbursement is won or lost in the clinical strategy. Ours is designed by people who know what HAS, NICE and the sickness funds actually expect.
Dr Mark Da Costa
Comparative and health-economic study design feeding reimbursement dossiers across Europe.
in LinkedIn
Sébastien Meier
Endpoints, statistics and real-world evidence designed to satisfy HTA and reimbursement reviewers.
Quick reference
Four markets, four systems.
There is no European-level reimbursement body — each Member State assesses independently. CE marking is a prerequisite for all, but confers no reimbursement rights in any.
| Country | Body | Key pathway | Primary evidence | CE → reimb. |
|---|---|---|---|---|
| France | HAS · CEPS (price) | LPPR listing | SSMR + ASMR; RCT / comparative preferred | 18–36 mo |
| Germany | GKV-SV · BfArM (DiGA) | DRG / NUB, or DiGA for SaMD | Clinical benefit vs standard of care; RWE for NUB; DiGA pilot within 12 mo | 12–24 mo (NUB) · 3 mo (DiGA) |
| UK | NICE · NHS England | MedTech Assessment (MTA) or Early Value Assessment (EVA) | Clinical + cost-effectiveness; QALY; RWE increasingly accepted | 18–36 mo (MTA) · 6–12 mo (EVA) |
| Italy | AIFA · Ministry of Health | National tariff (DRG / DM) or regional procurement | Safety & performance; strong reliance on registries | 24–48 mo |
Country by country
The four systems, in detail.
France
HAS, LPPR and the ASMR that sets your price
France assesses through HAS, which grades the actual clinical benefit (SSMR) and the added benefit versus existing options (ASMR). A strong ASMR unlocks a better price negotiated by CEPS and a favourable LPPR listing. The lever is comparative evidence: an RCT or a robust comparative study is preferred, and a weak ASMR is where value is lost. Plan for 18–36 months from CE mark.
Germany
GKV-SV, NUB and the DiGA fast-track
Germany reimburses conventional devices through DRG and the NUB process for new methods, where real-world evidence is accepted. For software as a medical device, the DiGA fast-track is the fastest route in Europe — listing in around three months, with a pilot study to be completed within twelve. The evidence bar is clinical benefit versus the standard of care.
United Kingdom
NICE, the QALY and the EVA shortcut
Post-Brexit, NICE assesses clinical and cost-effectiveness on a QALY framework, through a full MedTech Assessment or the faster Early Value Assessment. Real-world evidence is increasingly accepted. Health-economic modeling is not optional here — it is the language of the decision.
Italy
AIFA, national tariffs and the registry reliance
Italy lists through national DRG/DM tariffs or regional procurement, with the Ministry of Health involved for devices. Clinical registries — national and regional — carry unusual weight, so a registry strategy is central. Timelines are the longest of the four, up to 48 months nationally, with regional variation.
The through-line
Reimbursement is a clinical decision, made early.
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