---
title: Reimbursement for Digital Health in Europe: Beyond DiGA
description: Reimbursement digital health Europe beyond DiGA: Germany, France PECAN, Belgium m-Health. Country-by-country evidence, MDR overlap, dual-pathway strategy.
authors: Tibor Zechmeister, Felix Lenhard
category: Funding, Business Models & Reimbursement
primary_keyword: reimbursement digital health Europe beyond DiGA
canonical_url: https://zechmeister-solutions.com/en/blog/reimbursement-digital-health-europe-beyond-diga
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# Reimbursement for Digital Health in Europe: Beyond DiGA

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **Germany's DiGA is the most developed digital health reimbursement pathway in Europe, but it is not the only one. France has PECAN, Belgium runs the mHealthBelgium pyramid, and several other countries are building their own routes. For a SaMD startup, the smart play is not to pick one — it is to design the evidence stack so the same data satisfies MDR Rule 11 classification, CE marking, and two or three reimbursement dossiers in parallel.**

**By Tibor Zechmeister and Felix Lenhard.**

## TL;DR
- Germany's DiGA remains the most mature and codified digital health reimbursement pathway in Europe, but it is narrow in scope and demanding on evidence.
- France's PECAN offers early access reimbursement for digital therapeutics and remote monitoring while full HAS assessment happens.
- Belgium's mHealthBelgium uses a three-level pyramid: CE mark, interoperability/security, and reimbursement evidence.
- All three require a CE-marked medical device, which under MDR Rule 11 typically pushes most clinical SaMD into Class IIa or higher.
- The evidence demands overlap significantly — a well-designed CER and PMCF plan can feed multiple dossiers.
- A dual- or triple-pathway strategy is usually cheaper than sequential national launches, but only if planned from the start.

## Why this matters for MedTech founders

Almost every digital health founder we meet has heard of DiGA and assumes it is the default. It is not. It is one of several fast-track reimbursement pathways in Europe, each with its own evidence bar, its own timeline, and its own political weather. Companies that build their regulatory and evidence strategy around DiGA alone often discover — a year into the process — that a France-first or Belgium-first launch would have been faster, cheaper, or both.

The other misconception is that reimbursement and regulation are separate workstreams. For digital health, they are not. Every national pathway we will look at requires CE marking as a medical device first. And under MDR Annex VIII Rule 11, any software intended to provide information for diagnostic or therapeutic decisions is usually Class IIa or higher. That single classification rule defines the whole programme: Notified Body involvement, clinical evaluation depth, QMS certification, PMCF obligations, and the size of your evidence package.

This post walks through the three most developed pathways, what each actually demands, how they overlap, and how to design a dual-pathway strategy that does not double the cost.

## What MDR actually says about SaMD classification

Before reimbursement, 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 if such decisions have an impact that may cause death or an irreversible deterioration of a person's state of health (Class III) or a serious deterioration (Class IIb). Software intended to monitor physiological processes is Class IIa, except if it is intended for monitoring vital physiological parameters where variations could result in immediate danger (Class IIb). All other software is Class I.

In practice, most clinical SaMDs that a payer would consider reimbursing fall into Class IIa or higher. That means a Notified Body is involved, which means 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. MDCG 2019-11 Rev.1 (June 2025) is the authoritative interpretation and includes worked examples.

Why does this matter for reimbursement? Because every national pathway demands a CE-marked device as a precondition. Your regulatory classification decision is the gate to the reimbursement conversation.

## Germany: DiGA — the benchmark

DiGA (Digitale Gesundheitsanwendung) is a reimbursement fast track created by the Digital Healthcare Act (DVG, 2019) for lower-risk digital health applications — essentially Class I and Class IIa under MDR. The BfArM operates the DiGA directory. Once listed, statutory health insurers reimburse the app for roughly 70 million insured Germans.

The core evidence demand is a "positive healthcare effect" (pVE) — either a medical benefit or a patient-relevant structural and procedural improvement. The default pathway is preliminary listing for up to 12 months (extendable to 24) during which you run a controlled trial to demonstrate the effect, followed by permanent listing. Alongside clinical evidence you need data protection, information security, interoperability, and quality requirements, all codified in the DiGA Guide.

The rough numbers: the average pVE trial for a preliminary listing costs several hundred thousand euros, the preliminary listing process takes around three months after submission, and the first-year negotiated price is set by the manufacturer (within limits) before being renegotiated with the GKV-SV federation after 12 months. For founders, DiGA is attractive because the market is huge and the rules are written down. It is demanding because the evidence bar is specific, the price renegotiation is aggressive, and only Class I and IIa devices qualify — Class IIb and III are out.

## France: PECAN — early access for digital

PECAN (Prise En Charge Anticipée Numérique) launched in 2023 as France's early reimbursement pathway for digital therapeutics and remote monitoring devices. It sits alongside the full HAS (Haute Autorité de Santé) assessment route and is intended to bridge the gap between CE marking and full reimbursement while real-world evidence is generated.

The logic of PECAN is simpler than DiGA. You submit a dossier to HAS demonstrating presumed clinical benefit, data protection compliance, interoperability, and a plan to generate confirmatory evidence. If accepted, you get one year of reimbursement at a negotiated price, during which you collect the real-world data that will support the full HAS assessment for permanent reimbursement under the LPPR (List of Reimbursable Products and Services).

What makes PECAN interesting for startups is the early cash flow — you can start generating revenue while the full evidence dossier matures. What makes it demanding is the French-market specifics: HAS values comparator data and cost-effectiveness arguments more than some other European bodies, and documentation must be in French. A CE-marked device is a prerequisite.

## Belgium: mHealthBelgium — the pyramid

Belgium's mHealthBelgium pathway is structured as a three-level pyramid. Level 1 is the CE-marked medical device. Level 2 adds interoperability, information security, and connection to the national eHealth platform. Level 3 requires clinical and socio-economic evidence sufficient to justify reimbursement by the RIZIV/INAMI (the Belgian statutory insurer) or by specific hospital budgets.

Level 3 is the reimbursement tier. The evidence demands are not as codified as DiGA and the market is smaller — around 11.5 million people — but the pyramid approach lets a manufacturer build credibility step by step. A startup can reach Level 2 quickly after CE marking, use that status to sell to hospitals directly, and work towards Level 3 reimbursement with real-world data generated through those hospital deployments.

For many digital health startups, Belgium is the fastest "soft launch" market in Europe: CE mark plus Level 2 can open hospital procurement conversations within months, without the full weight of a DiGA or PECAN dossier.

## Others worth knowing about

Austria, the Netherlands, and the Nordics each have emerging frameworks. Austria has piloted specific digital-health reimbursement through social insurance carriers. The Netherlands reimburses selected digital interventions through the ZIN (Zorginstituut Nederland) after HTA. The UK, outside the EU, operates NICE's Evidence Standards Framework for digital health technologies and NHS England's Digital Technology Assessment Criteria (DTAC). None are as fast or codified as DiGA, PECAN, or mHealthBelgium, but a startup planning multi-market launch should track them.

## The evidence overlap — where the leverage is

Here is the practical insight. Look at what all three codified pathways demand.

- CE-marked medical device with current technical documentation and CER. (MDR)
- Clinical evidence of benefit, ideally from a controlled study with a validated endpoint.
- Post-market plan for continuing real-world data collection. (MDR PMCF)
- Information security and data protection documentation. (GDPR and ISO 27001-adjacent)
- Interoperability specifications (varies by country; HL7 FHIR is the common denominator).
- Usability evidence under EN 62366-1:2015+A1:2020.
- Software lifecycle documentation under EN 62304:2006+A1:2015.

The overlap is enormous. A well-structured CER, a well-written PMCF plan, a clean SBOM, a GDPR-compliant data flow diagram, and a FHIR-based API will satisfy most of the technical annexes of all three pathways. What differs is the specific clinical endpoint the national body cares about, the local language requirements, and the price negotiation process.

The founders who waste money build three separate evidence stacks. The founders who do it right build one evidence stack designed to feed multiple dossiers, then translate and localise at the end.

## A worked example: a CBT-based digital therapeutic for insomnia

Consider a Class IIa SaMD — a cognitive behavioural therapy app for chronic insomnia, CE-marked, targeting reimbursement in Germany, France, and Belgium.

The startup designs its pivotal trial with two endpoints: the Insomnia Severity Index (ISI) at 8 weeks (primary) and sleep diary-derived sleep efficiency (secondary). ISI is validated, accepted by BfArM for DiGA pVE trials, and recognised by HAS. Sleep efficiency is clinically meaningful and useful for PMCF.

The PMCF plan pulls continuous in-app ISI scores every 4 weeks, with a real-world cohort of at least 2,000 patients in year one. The same data feeds the DiGA pVE, the PECAN confirmatory dossier, and the mHealthBelgium Level 3 evidence package. The evidence budget is roughly 60 percent of what three independent dossiers would have cost.

Regulatory classification is confirmed as Class IIa under Rule 11 with MDCG 2019-11 Rev.1 as the supporting reference. The Notified Body reviews the clinical evaluation once, the manufacturer submits to BfArM for preliminary DiGA listing, applies for PECAN in parallel, and uses CE mark plus Level 2 status to open Belgian hospital pilots immediately.

By month 18 the company has DiGA preliminary listing, PECAN early access, mHealthBelgium Level 2 status, and a real-world cohort large enough to finalise all three dossiers. Total evidence spend: well below what a DiGA-only path would cost if followed by sequential French and Belgian launches.

## The Subtract to Ship playbook for dual-pathway reimbursement

1. Decide your primary and secondary markets before you design the pivotal trial. Your primary endpoint must satisfy the most evidence-demanding pathway you intend to enter.

2. Build the evidence stack once. CER, PMCF plan, SBOM, data flow, interoperability spec — all designed to feed every dossier you will submit.

3. Classify under MDR Rule 11 honestly. Do not argue your way down to Class I to avoid Notified Body involvement; all three reimbursement pathways demand real clinical evidence anyway, and downclassification that does not hold up in audit destroys credibility.

4. Start the Belgian pyramid early. Level 2 is cheap, fast, and opens hospital doors while you work on the heavier German and French dossiers.

5. Budget for translation and local regulatory counsel from day one. The evidence is portable; the language and the price negotiation are not.

6. Plan the PMCF plan as a commercial asset. Your PMCF is the data machine that feeds reimbursement renewals — not a regulatory chore. Resource it accordingly.

## Reality Check

1. Is your device classified correctly under MDR Annex VIII Rule 11, and do you have a classification justification document a Notified Body would accept?
2. Does your pivotal trial measure an endpoint that BfArM, HAS, and RIZIV/INAMI would all recognise?
3. Is your CER written to a standard that satisfies a Notified Body review and also supports a reimbursement dossier?
4. Have you planned your PMCF as a continuous data pipeline rather than a one-shot study?
5. Do you have GDPR, information security, and interoperability documentation ready to drop into each national dossier?
6. Have you modelled the cash flow of sequential vs parallel market entry?
7. Do you know which national language requirements apply to each dossier, and have you budgeted translation?
8. Is your price strategy consistent across markets, or are you creating arbitrage problems?

## Frequently Asked Questions

**Is DiGA still the fastest digital health reimbursement in Europe?**
For Class I and IIa consumer-facing apps targeting the German statutory insurance market, yes. For hospital-based devices or cross-border launches, PECAN or mHealthBelgium Level 2 can be faster.

**Can a Class IIb device be listed under DiGA?**
No. DiGA is limited to Class I and IIa under current rules. Higher-risk devices use the standard reimbursement routes.

**Does PECAN require a French-run clinical trial?**
No, but HAS values French real-world evidence and comparator data. A multi-country pivotal trial with a French arm strengthens the dossier significantly.

**Does mHealthBelgium Level 2 count as reimbursement?**
No. Level 2 is validation and interoperability; Level 3 is reimbursement. But Level 2 often unlocks hospital procurement, which is effectively cash flow.

**Can one CER support DiGA, PECAN, and mHealthBelgium?**
Yes, if you design it that way. The MDR CER is the core document; each national dossier adds a country-specific wrapper.

**What about the UK and Switzerland?**
Different regulatory and reimbursement regimes. The UK uses DTAC and NICE guidance; Switzerland has its own medical device regulation (MedDO) aligned with MDR plus separate reimbursement negotiation. Plan these as separate workstreams.

## Related reading

- [Health insurance reimbursement in Europe](/blog/health-insurance-reimbursement-europe) — the wider reimbursement landscape this sits inside.
- [German reimbursement for medical devices](/blog/german-reimbursement-medical-devices) — the DiGA pathway in detail.
- [MDR classification Rule 11 for software](/blog/mdr-classification-rule-11-software) — the gate that determines your reimbursement options.
- [SaMD complete regulatory path for startups 2026](/blog/samd-complete-regulatory-path-startups-2026) — the end-to-end SaMD route under MDR.
- [HTA submissions for medical devices](/blog/hta-submissions-medical-devices) — how HTA bodies assess the evidence you submit.

## Sources

1. Regulation (EU) 2017/745 on medical devices, consolidated text. Annex VIII Rule 11; Article 51.
2. MDCG 2019-11 Rev.1 (October 2019, Rev.1 June 2025) — Software qualification and classification.
3. EN 62304:2006+A1:2015 — Medical device software lifecycle processes.
4. EN 62366-1:2015+A1:2020 — Usability engineering for medical devices.

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*This post is part of the [Funding, Business Models & Reimbursement](https://zechmeister-solutions.com/en/blog/category/funding-reimbursement) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*