Germany's DiGA is the most visible digital health reimbursement pathway in Europe, but it is not the only one. France runs PECAN for early access, Belgium operates the mHealthBelgium validation pyramid, and several other member states are drafting their own routes. Each has its own evidence bar, its own timeline, and its own institutional gatekeepers. A SaMD founder who treats DiGA as the default is likely choosing the hardest pathway by accident.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • DiGA is the most mature digital health pathway in Europe, but the clinical and financial evidence bar is higher than the marketing story suggests.
  • France's PECAN gives early market access to digital therapeutics and remote monitoring while full HAS assessment runs in parallel.
  • Belgium's mHealthBelgium uses a three-level pyramid that separates CE marking, interoperability and security, and reimbursement evidence into sequential gates.
  • Austria, the Netherlands, and several Nordic countries are drafting or piloting their own digital health pathways. Every one of them presumes a CE-marked medical device as the entry ticket.
  • Under MDR Annex VIII Rule 11, most clinical SaMD lands in Class IIa or higher, which means a Notified Body, a full clinical evaluation, and a PMCF plan. That work is shared infrastructure across every pathway.
  • The smartest move for a small team is to design the evidence package once and reuse it across two or three national dossiers in parallel.

Why this matters for MedTech founders

Felix has coached several digital health startups that arrived at their first strategy session convinced the plan was "get CE mark, submit to DiGA, unlock Germany, scale." It almost never ends up that simple. Tibor has heard the same story from the other side of the table. Founders assume DiGA is a one-way revenue escalator and discover a year in that the reimbursement rate declines over time, that the evidence bar is higher than they expected, and that the politics of dealing with more than 90 statutory sickness funds in Germany is its own full-time job.

The harder truth is that DiGA is one of several fast-track digital health pathways in Europe. None of them is easy. All of them require a CE-marked device first. And every country's process is evolving quickly, which is why regulatory and reimbursement intelligence has a short half-life in this space.

This post gives a high-level comparison of the most visible pathways, flags where the fine detail is moving fast, and points at the MDR articles that anchor every decision. Where country-specific process details are moving faster than a blog post can track, the claim is flagged [MDR VERIFY] so readers know to confirm before acting.

What MDR actually says about the gate to every pathway

Before any reimbursement conversation, classification. MDR Annex VIII, Rule 11 states that software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as Class IIa, except where those decisions may cause death or an irreversible deterioration (Class III) or serious deterioration (Class IIb). Software intended to monitor physiological processes is Class IIa, except where it monitors vital physiological parameters whose variations could result in immediate danger (Class IIb). Everything else is Class I.

MDCG 2019-11 Rev.1 (June 2025) is the authoritative interpretation with worked examples. The practical consequence is that most SaMD a payer would consider reimbursing sits in Class IIa or higher. Class IIa pulls in a Notified Body, which in turn pulls in a clinical evaluation under MDR Article 61 and Annex XIV Part A, a PMCF plan under Annex XIV Part B, and a PSUR under Article 86.

Every national digital health pathway below presumes this work is already done or in flight. That is the shared spine. What differs from country to country is what additional evidence each national body wants on top.

Germany: DiGA, the benchmark

The official German story is clean. Get CE marked. Submit the dossier to BfArM. Enter the DiGA directory, either provisionally for up to 12 months while the clinical effect study runs, or permanently after positive demonstration of a positive healthcare effect. Prescribing doctors then write the DiGA on a prescription and statutory sickness funds reimburse.

The reality is less clean. BfArM expects significant clinical evidence of benefit to patients and to the German healthcare system. Tibor has heard from multiple DiGA-approved manufacturers that initial reimbursement rates are acceptable but decline over time, with some technologies becoming uneconomical to continue. The market is real and it is the biggest in Europe, but access is not automatic, and Germany's more than 90 statutory sickness funds make a difference in adoption velocity on a fund-by-fund basis.

For class, data protection, interoperability, and the specifics of the BfArM fast-track process, founders should treat the published guide as the living source and contact manufacturers who have gone through it. .

France: PECAN and the broader French route

France's PECAN (prise en charge anticipée numerique) framework provides early access reimbursement for digital medical devices and digital therapeutics while the full Haute Autorite de Sante evaluation happens in parallel. The idea is similar to DiGA's provisional listing: get the device reimbursed under a time-limited arrangement, gather the confirmatory real-world or clinical evidence during that window, then convert to full reimbursement via the standard LPPR / CNEDiMTS route.

Where PECAN differs from DiGA in practice is the institutional gatekeepers. HAS and CNEDiMTS have their own traditions around medical device evaluation and their own preferences for study design. French clinical evidence expectations tend to mirror pharmaceutical practice more closely than the German fast-track model. .

The strategic takeaway is that France is a realistic second or even first market for digital therapeutics, not just a DiGA fallback. For teams whose clinical evidence strategy is mature and who have French-language capability, PECAN can move faster than teams assume.

Belgium: the mHealthBelgium pyramid

Belgium's mHealthBelgium framework uses a three-level pyramid model that makes its sequencing explicit.

Level 1 is CE marking as a medical device under MDR, plus registration in the Belgian national database. That is the entry ticket. No device, no conversation.

Level 2 adds interoperability with the Belgian eHealth platform and demonstration of information security and data protection. This is where the cybersecurity and GDPR posture of the product is tested in concrete terms, not just in a QMS document.

Level 3 adds clinical and socio-economic evidence sufficient to unlock reimbursement. This is where the comparative evidence, the real-world effect data, and the budget impact analysis live.

The pyramid is useful even for founders who have no intention of launching in Belgium first, because it makes the sequencing of work visible. CE mark before interoperability before reimbursement evidence. That order rarely works in reverse. .

Other emerging national frameworks

Several other European countries are building or piloting their own digital health pathways. Austria has public discussion around a digital reimbursement route. The Netherlands has sectoral initiatives under Zorginstituut Nederland. The Nordics run national digital health programmes with different names and different levels of formalisation. The UK, post-Brexit, has NICE and the Evidence Standards Framework for Digital Health Technologies, which is not a fast-track reimbursement pathway but is influential across NHS procurement.

All of this is moving quickly. A blog post from 2026 about "the state of PECAN" will age within a year. The durable principles are the ones anchored in MDR: classification under Rule 11, clinical evaluation under Article 61, PMCF under Annex XIV Part B, and post-market surveillance under Articles 83 to 86. These do not move. The national reimbursement conditions built on top of them do. .

A worked example

A team is building a Class IIa SaMD for guided CBT in insomnia. The founder's instinct is DiGA-first because Germany is the biggest market. Tibor's view, consistent with what he hears from DiGA-approved founders, is that the clinical evidence bar for BfArM is higher than the Class IIa CE-mark minimum and that the reimbursement revenue declines over time as the statutory funds negotiate the price down.

A dual-pathway read of the same product looks different. The evidence package that would satisfy BfArM (randomised controlled trial on adult insomnia patients against a credible comparator, with German-language primary outcomes) also substantially feeds PECAN and mHealthBelgium level 3. Running the CE-mark clinical evaluation, the BfArM application, the PECAN application, and an mHealthBelgium level 1-2 submission in parallel is more work than picking one, but it is not three times the work. The shared spine, the MDR Article 61 clinical evaluation, the Annex XIV Part B PMCF plan, and the QMS under EN ISO 13485:2016+A11:2021, is the same in every dossier.

The Subtract to Ship playbook

Design the evidence once, reuse it everywhere. Start from the MDR obligations. Use Rule 11 to classify. Use Article 61 and Annex XIV Part A to plan the clinical evaluation. Plan the PMCF under Annex XIV Part B. These are the non-negotiable artefacts.

Then layer the national pathway questions on top. For each candidate country, list what the national body adds to the MDR baseline. In every case so far, what the national body wants is more clinical evidence, more real-world data, more interoperability proof, or more budget impact analysis. Almost never does it relax an MDR requirement.

Pick the two national pathways whose additions overlap the most with each other and with your natural go-to-market. Submit those in parallel. Defer the third pathway until the first two have returned signal. Do not design around DiGA by default. Design around the country that matches your clinical evidence, your language capability, and your commercial network.

And build the update discipline. Every national pathway above is moving. Put a calendar reminder every quarter to re-check the official sources and speak to one peer founder who has actually walked the path you are planning.

Reality Check

  1. Have you confirmed your device's MDR classification under Annex VIII Rule 11, with a documented justification?
  2. Do you know which national pathway maps best to your clinical evidence plan, or are you defaulting to DiGA because it is the best known?
  3. Have you spoken to at least one founder who has completed the national pathway you are targeting, and do you know what their post-approval reimbursement trajectory looked like?
  4. Is your clinical evaluation plan designed so that the same dataset can feed two or more national dossiers?
  5. Does your team have working-level language and regulatory capability for each country you are targeting?
  6. Have you stress-tested the business model against a declining reimbursement rate over three to five years after listing?
  7. Do you have a quarterly update process for monitoring changes to PECAN, mHealthBelgium, BfArM, and any other pathway that affects your plan?

Frequently Asked Questions

Is DiGA the only digital health fast track in Europe? No. France has PECAN, Belgium has mHealthBelgium, and several other countries have or are building their own pathways. DiGA is the most visible and the most codified, which is why it gets the most attention.

Do all digital health pathways require a CE mark first? Yes. Every pathway above requires the device to be a CE-marked medical device under MDR before any reimbursement application. That is the gate. Classification usually lands in Class IIa or higher under MDR Annex VIII Rule 11.

Can the same clinical evidence satisfy DiGA, PECAN, and mHealthBelgium? Substantially, yes, if it is designed that way from the start. The shared spine is the MDR Article 61 clinical evaluation plus the PMCF plan. Each national body adds its own requirements on top, but the core can be reused.

Why does DiGA reimbursement decline over time? Multiple DiGA-approved manufacturers have reported that initial reimbursement is acceptable and then declines as the statutory sickness funds renegotiate. Some technologies become uneconomical to continue. Founders should model this in their business case before committing.

Why is so much of this post flagged [MDR VERIFY]? National digital health pathways are moving quickly. Specific timelines, evidence thresholds, and eligible device categories change frequently. The durable anchors are MDR articles, which do not move. Country-specific detail should always be confirmed against the current official source before any decision.

How many national pathways should a startup pursue at once? Two is usually the sweet spot for small teams. One is fragile because any single-country delay kills the plan. Three stretches small teams past the point where evidence reuse offsets the extra workload.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Annex VIII Rule 11, Article 51, Article 61, Annex XIV Parts A and B.
  2. MDCG 2019-11 Rev.1 (June 2025). Qualification and classification of software under MDR and IVDR.
  3. MDCG 2020-5 (April 2020). Clinical evaluation equivalence.
  4. MDCG 2025-10 (December 2025). Post-market surveillance.