By Christoph Eberhardt · CEO, DUX Healthcare · 19 April 2026
A DTx company expanding across Europe in 2026 faces ten national reimbursement projects, not one European market. The MDR harmonises the regulatory gate – CE marking is portable across the EEA – but reimbursement remains national competence, and every country runs its own logic. This article maps the ten European markets that matter for digital therapeutics: where reimbursement is operational, where pilot frameworks exist without statutory reimbursement, and where the path is fragmented or absent. Written for DACH-based DTx companies after a DiGA listing and for international DTx companies sequencing European entry; the German DiGA pathway as a reference point.
What a “DTx market map” really captures
A DTx market map is not one axis. It is the intersection of three distinct questions, and collapsing them is the largest source of misanalysis in the public literature on European digital health.
First, the regulatory question: is the product a lawful medical device? Inside the EU and EEA, this is the MDR (Regulation (EU) 2017/745). Every DTx in this map is CE-marked as a Class I, IIa, or IIb medical device under the MDR. Switzerland mirrors the MDR in the MepV (SR 812.213). The UK operates a transitional regime after Brexit. The MDR gate is portable across Europe.
Second, the assessment question: who judges whether the software is “good enough” for the health system? This varies wildly. Germany’s BfArM runs a combined regulatory-and-reimbursement review. France’s HAS runs PECAN. The UK’s NICE ESF plus NHS DTAC is assurance; NHS trusts and Integrated Care Systems decide procurement. Belgium’s mHealthBelgium runs a three-tier validation pyramid. These frameworks answer different questions and are not interchangeable.
Third, the payment question: does a national payer, a regional payer, a private insurer, or nobody reimburse the product? A product can be CE-marked, DTAC-assessed, and still fail to be reimbursed because no payment route exists. Germany is distinctive in that all three questions land at one pathway. The map below is organised by payment, because that is what a DTx company ultimately cares about.
The classification – reimbursement-ready, piloting, fragmented
The defensible 2026 cut is three tiers:
- Tier 1 – Reimbursement-ready: Germany, France, Belgium. A DTx manufacturer with a compliant product, clinical evidence, and the right commercial footprint can enter and be paid under a defined, published pathway on a statutory clock. Scale varies – Germany is an order of magnitude larger than either – but the mechanism works end-to-end.
- Tier 2 – Piloting / partial: UK, Switzerland, Austria, Italy. A framework exists, evidence is assessed, some products are procured or reimbursed – but the pathway is either not statutory, not nationwide, not at scale, or all three. Market access is possible but not a single-decision event.
- Tier 3 – Fragmented or absent: Netherlands, Nordics (SE, DK, NO, FI), Spain. No DTx-specific framework, or frameworks still exploratory with no durable reimbursement route.
The comparison at a glance
| Country | Framework | Reimbursement? | Status in 2026 |
|---|---|---|---|
| Germany | DiGA (§ 33a, § 139e SGB V; DiGAV) | Yes – statutory, nationwide, single decision | Tier 1 – operational at scale |
| France | PECAN + LPPR numérique | Yes – early-access + permanent reimbursement by Assurance Maladie | Tier 1 – operational, smaller cohort |
| Belgium | mHealthBelgium (M1/M2/M3-light/M3-plus) + NIHDI | Partially – M3 reimbursed via NIHDI per care pathway | Tier 1 – operational, narrower |
| United Kingdom | NICE ESF (ECD7) + NHS DTAC + local commissioning | No unified national reimbursement; regional procurement via ICSs | Tier 2 – assurance yes, reimbursement fragmented |
| Switzerland | MepV + Swissmedic; voluntary private/complementary reimbursement | Limited – some KVG positions, private insurers case-by-case | Tier 2 – regulatory yes, reimbursement partial |
| Austria | MDR; AGES/BASG; no DiGA-Vorbild materialised | No DTx-specific reimbursement pathway | Tier 2 – frameworks partial |
| Italy | MDR; Ministry of Health digital-health plan; regional schemes | Regional/indication-specific; no national DTx list | Tier 2 – fragmented national, some regional |
| Netherlands | Zvw/Wlz basispakket; ZIN + NZa | Case-by-case; via existing prestaties/tarieven | Tier 3 – fragmented (no DTx-specific pathway) |
| Nordics (SE/DK/NO/FI) | National medical-product agencies; regional procurement | Regional/hospital-level; no national DTx list | Tier 3 – fragmented |
| Spain | AEMPS; regional CCAA health services | No DTx-specific reimbursement framework | Tier 3 – absent |
Germany – the DiGA reference point
Germany is the anchor of this map. The DiGA is, as of 2026, the only European reimbursement pathway that combines regulatory approval and payment into one statutory decision at national scale. The legal scaffolding sits in § 33a SGB V, § 139e SGB V, and the DiGAV as amended on 27 January 2026.
What makes the DiGA pathway unusually consequential: the BfArM decision is simultaneously a regulatory layer on top of CE marking and the gate to statutory reimbursement by GKV covering ~73 million insured people (one decision, one listing, one price). DiGAV § 10 requires a comparative study demonstrating positive Versorgungseffekte. BSI TR-03161 is certified per DiGA, mandatory since 1 January 2025 and application-relevant since 1 July 2025. The ePA interoperability obligation under DiGAV § 6a has been in force since 1 January 2024. From 1 January 2026, at least 20% of the negotiated reimbursement price must be tied to outcome parameters captured by AbEM – the single most significant DTx policy shift in Europe in 2026, moving the commercial risk of an ineffective app from payer to manufacturer.
The DiGA is the fastest reimbursement path in Europe for the right product, and its evidence package is materially reusable in France and Belgium. The full coverage lives at /knowledge/diga/ and, for international applicants, at Market Access Germany.
France – PECAN and the LPPR numérique
France is the most consequential Tier-1 market after Germany. The central mechanism is PECAN (Prise en Charge Anticipée Numérique), introduced by Article L. 162-1-23 of the Code de la sécurité sociale and codified in CSS Art. R162-112 à R162-121 (Décret 2023-232 of 30.03.2023, amended by Décret 2024-1267 and Décret 2025-1286 with effect from 1 January 2026). PECAN sits alongside the permanent reimbursement route on the LPPR (Liste des Produits et Prestations Remboursables) under Art. L. 165-1 CSS, administered by the HAS (Haute Autorité de Santé) via the CNEDiMTS commission.
The structural parallel to DiGA’s preliminary-listing path is strong: PECAN allows a CE-marked DTx with an initial evidence base to access early reimbursement while studies in progress generate the data the CNEDiMTS needs. HAS PECAN principles (September 2025) sets out the two eligibility anchors: CE marking in the claimed indication, and a presumption of innovation. CE marking under MDR is a hard precondition; assessment combines regulatory fit and reimbursement eligibility.
What diverges from DiGA: French-language localisation is a non-trivial workstream; the listed cohort is materially smaller than DiGA’s ~74 listings; reimbursement price is set through CEPS negotiation rather than a manufacturer-set first year. For a DTx company already pursuing DiGA, PECAN is the most efficient second-market filing. The MDR file, most clinical evidence, and large parts of the cybersecurity posture are reusable. A team with a DiGA listing in hand reaches a PECAN dossier in 6–9 months of focused work.
Belgium – mHealthBelgium
Belgium runs mHealthBelgium, a validation pyramid for mobile medical applications and digital therapeutics jointly operated by FAMHP and NIHDI (INAMI/RIZIV).
The tiers: M1 confirms the product is a CE-marked medical device, notified to the FAMHP, with a GDPR self-declaration. M2 indicates the manufacturer has submitted a reimbursement request to NIHDI that has been declared admissible and the app meets the mHealthBelgium ICT criteria. M3 is reserved for applications funded by NIHDI and splits into M3-light (temporary financing) and M3-plus (definitive after socio-economic value proof). Each M3 listing is tied to a specific care pathway.
A DiGA file translates materially into an mHealthBelgium M2/M3 submission: MDR documentation covers M1, BSI TR-03161 cybersecurity posture overlaps the Belgian ICT criteria, and DiGA positive-care-effect studies feed M3 socio-economic evidence. What must be built fresh: Dutch and French language coverage (effectively mandatory), integration with Belgian eHealth infrastructure (eHealth platform, Recip-e), and the NIHDI submission. A DiGA-listed DTx company targeting mHealthBelgium M3 with reimbursement: 9–12 months, dominated by the indication-specific NIHDI process.
United Kingdom – NICE ESF, DTAC, and fragmented reimbursement
The UK is the largest European market where regulatory-and-assessment infrastructure is mature but national-scale DTx reimbursement is not. Three frameworks matter, none of them a reimbursement decision on its own: the NICE Evidence Standards Framework (ECD7) (last updated 9 August 2022), NHS DTAC (DTAC Form 2.0 mandatory from 6 April 2026), and local NHS commissioning via Integrated Care Systems (ICSs) – where reimbursement actually happens. There is no single NHS DTx list at England-wide level.
Post-Brexit, CE-marked medical devices on the Great Britain market continue to be accepted via MHRA-recognised routes while UKCA consolidates; the MHRA’s Software and AI as a Medical Device Change Programme governs the direction of travel. Northern Ireland remains aligned with EU MDR under the Windsor Framework.
UK sits in Tier 2: assurance frameworks mature, fragmented reimbursement means there is no single-decision route to the NHS patient population at scale. A DTx company’s UK play is typically a NICE-aligned evidence package combined with direct ICS engagement in priority indications.
Switzerland – MepV-compliant product, partial reimbursement reality
Switzerland is regulated but not a statutory DTx market. The MepV (SR 812.213), in force since 26 May 2021, transposes the substance of EU MDR into Swiss law. Swissmedic operates as the competent authority. Since the EU–Switzerland MRA on medical devices lapsed, Switzerland is a third country from the EU’s perspective: a CE-marked EU DTx requires a CH-REP and Swiss economic-operator registration.
Reimbursement reality differs from the regulatory picture. Switzerland has no Swiss-DiGA. Coverage routes through KVG tariff positions (some DTx-adjacent services under existing positions, not DTx-specific), supplementary/private insurance (voluntary, varies by insurer), or hospital and canton-level procurement.
For a DTx company with a DiGA listing and a PECAN dossier, Switzerland is typically a low-priority market in 2026 – regulatory work is real, reimbursement upside patchy.
Austria, Italy, Netherlands, Nordics, Spain
Austria. A DiGA-Vorbild was discussed 2021–2024 but has not materialised. Standard MDR via BASG, mature ELGA infrastructure (not tied to reimbursement), individual-case reimbursement by SV-Träger.
Italy. Standard MDR. SSN with 20-region autonomy. Lombardia, Emilia-Romagna, Veneto run more mature digital-health procurement; no national DTx list.
Netherlands. Zorginstituut Nederland (ZIN) governs whether digital and hybrid care belongs in the Zvw and Wlz basispakket. Its Handleiding Beoordeling digitale en hybride zorg (March 2025) distinguishes four categories within primary care. The NZa Wegwijzer 2026 describes how digital care is paid within existing prestaties. Net effect: Dutch digital care can be reimbursed via the general Zvw/Wlz framework mediated by individual health insurers – not via a DiGA-equivalent single-decision route.
Nordics (SE/DK/NO/FI). Each with own medical-products agency. Procurement largely regional – regions in Sweden and Denmark, Helseforetak in Norway, Hyvinvointialueet in Finland since 2023. No DiGA-equivalent statutory pathway in 2026.
Spain. AEMPS regulates devices; SNS administered by 17 autonomous communities. No national DTx reimbursement framework.
For DTx expanding beyond Germany / France / Belgium / UK, these markets are opportunistic – engaged where a strategic partner pulls the product into a specific programme.
What’s missing from this map
There is no pan-EU DTx reimbursement pathway. The EU harmonises medical-device regulation via MDR but not reimbursement. The EU HTA Regulation introduces Joint Clinical Assessment from 12 January 2025 for oncology and ATMPs (from 12 January 2028 for orphan drugs, from 13 January 2030 for remaining medicinal products) – most DiGA-class software falls outside its current scope. EHDS addresses data spaces, not reimbursement. The EU AI Act adds high-risk-system obligations from August 2026, with medical-device-integrated conformity from August 2027. DTx reimbursement remains national competence.
Frequently asked questions
Which EU country reimburses DTx most reliably in 2026?
Is there a pan-EU DTx reimbursement pathway?
What's the fastest route into multiple EU markets for a DTx company?
Sequence matters more than speed: (1) lock the CE mark under MDR – the universal precondition; (2) list in Germany as a DiGA – the largest single-decision pathway, producing reference evidence (comparative study, BSI TR-03161 posture, ePA interoperability); (3) file in France under PECAN for early-access reimbursement; (4) pursue mHealthBelgium M2/M3 in Belgium; (5) pursue UK DTAC/NICE alignment, Swiss market access, and other markets opportunistically.
Inverting the sequence – UK or Switzerland first, then attempting DiGA – is usually slower because the German cybersecurity and data-protection bar is higher than its analogues and is not easily retrofitted.
Where DUX fits
DUX Healthcare is a German DTx platform company. Five DiGAs are currently under contract on the mHealth Suite platform — platform-engineered, each individually tested against BSI TR-03161 per DiGA, all CE-marked under MDR. DUX is the first company in Germany certified against BSI TR-03185 (Secure Software Lifecycle).
The European DTx map matters because the DiGA evidence, cybersecurity, and data-protection work built on the platform is materially reusable in France and Belgium – and because the single hardest step for non-EU entrants, the MDR legal-manufacturer question, sits at the gate of every national pathway. DUX offers a legal-manufacturer partnership through a partner structure for that specific blocker. Platform mechanics at /build/; the outbound expansion angle at /go-beyond/.
Related reading
- DiGA knowledge area – the full German reference.
- Market Access Germany – the international-applicant view of DiGA.
- DiGA vs FDA SaMD – the US-comparison sibling.
- Who qualifies as a DiGA applicant – the legal-manufacturer question.
- International Markets overview – the cluster this article anchors.
Practitioner take