Getting into the hospital is no longer the endgame. For MedTech startups in Europe, getting reimbursed — and doing so consistently across fragmented markets — is what separates hobby projects from scalable businesses.
In this second post of our series, we dive into the European market access landscape for medical devices and digital health, with a founder-focused lens on systems in Germany, France, the UK, and Nordic/CEE markets.
1. Germany: DiGA and the Fast Track for Digital Health
Germany remains Europe’s most structured digital reimbursement market thanks to the DiGA Fast Track, launched in 2020 by the Federal Institute for Drugs and Medical Devices (BfArM).
What qualifies: Apps or software-based interventions classified as low-risk medical devices (Class I or IIa under MDR).
Who pays: Statutory health insurance (covers 73M+ Germans).
Key Steps: 1. CE Marking as a medical device 2. Apply for DiGA listing (provisional or permanent) 3. Submit evidence (clinical, economic, usability)
Success story: Selfapy — a digital mental health therapy platform — was listed in 2022 and now reimbursed nationally.
Caution: Only 55 apps were listed as of mid-2025, with >40% later withdrawn due to insufficient evidence or pricing issues.
2. France: PECAN Pathway and Public Evaluation
France doesn’t have a DiGA equivalent yet, but the new PECAN pilot launched in 2023 offers early funding for digital therapeutics.
Agencies involved: – HAS (clinical evaluation) – CNAM (payer negotiations)
Key routes for market access: – PECAN for DTx and AI diagnostics (pilot program) – LPPR for physical devices (Listing for reimbursement)
Tip: Leverage French Tech Health20 status to speed up access via Bpifrance support.
3. United Kingdom: NICE, NHS Pathways, and DTAC
In the UK, access is driven by public health pilots and evidence-based appraisals.
Key frameworks: – NICE DHT Evidence Standards – NHS DTAC (Digital Technology Assessment Criteria)
Best path for startups: 1. Pilot with NHS via accelerators like NHS Innovation Accelerator 2. Gather local data and enter NICE appraisal 3. Align with Integrated Care Systems for regional deployment
Example: Huma has scaled UK pilots into global expansion after evidence-driven adoption in NHS settings.
4. Nordics: Digital-First, But Decentralized
Sweden, Denmark, and Finland lead in digital infrastructure but lack a unified reimbursement track.
Approach: – Run local hospital pilots (funded by Vinnova, Business Finland) – Engage with regional procurement bodies
Tip: Nordic health systems value co-creation and evidence transparency over hype.
5. Central & Eastern Europe: EU-Backed Access with Cost Advantage
In Poland, Romania, and Czechia, adoption is slower but aided by EU structural funds.
Tactics that work: – Partner with local CROs or academic hospitals – Position for structural fund-backed pilots – Focus on affordability + clinical value
Note: EIT Health plays an active role in startup acceleration and validation across CEE.
Summary Table: Market Access Pathways by Country
| Country | Key Framework | Entry Point | Reimburses Digital? |
| Germany | DiGA | BfArM application | ✅ Yes |
| France | PECAN / LPPR | HAS + CNAM | ⚠️ In pilot |
| UK | NICE / DTAC | NHS pilot + ICS | ✅ If evidence exists |
| Sweden | Local procurement | Regional pilots | ❌ No central track |
| Poland/CEE | EU-backed pilots | Academic/hospital use | ❌ Not at scale |
Takeaways for Founders
- Don’t treat Europe as one market — the access frameworks are radically different.
- Start with pilots and evidence in 1–2 strategic countries.
- Use programs like DiGA and PECAN if applicable, but expect pricing pressure and compliance overhead.
Up next in the series: 📌 Cracking Reimbursement — Value-Based Pricing for MedTech Startups
This content has been enhanced with GenAI tools.
