International Market Access – DTx Across Europe and Beyond

By Christoph Eberhardt · CEO, DUX Healthcare · 19 April 2026

Which European markets carry statutory reimbursement for digital therapeutics in 2026, and which parts of a DiGA dossier are reusable in France, Belgium, the UK, or Switzerland? And for non-EU teams: who can file a DiGA at all, and what does the path look like? This hub answers both — from the seat of a German platform partner with five DiGAs under contract and legal-manufacturer-partnership experience for non-EU teams, against MDR (CE portability), DiGAV § 4 para. 3 (EU/EEA data residency), MDR Art. 11 (authorised representative for non-EU manufacturers) and the EU HTA Regulation (Reg. (EU) 2021/2282).

DUX practice anchor: deepest experience on the German market-entry side for non-EU teams; for cross-border sequences from DACH into PECAN, mHealthBelgium, NICE ESF, MepV and the Netherlands, we reference country primary sources — a validated cross-border sequence has not been publicly documented by anyone in 2026.

What “international market access” means for digital therapeutics

For a prescription drug the sequence is familiar: regulatory authorisation, HTA, national reimbursement listing, physician and payer uptake. For a CE-marked medical device the sequence is looser but recognisable: CE mark under MDR, country-specific reimbursement where available, specific procurement tracks for hospitals.

For digital therapeutics the sequence is less standardised on the second half, and more rigorous on the first. CE marking under MDR is now the unambiguous European entry. Reimbursement is where the fragmentation starts: Germany has DiGA under § 33a SGB V; France has PECAN (prise en charge anticipée numérique) codified in Articles R162-112 to R162-121 of the Code de la sécurité sociale; Belgium has mHealthBelgium with a three-tier validation pyramid (M1/M2/M3); the UK runs NHS DTAC as an assurance framework alongside – not in place of – separate reimbursement routes, with NICE ESF (Evidence Standards Framework, ECD7) setting the evidence bar; Switzerland operates under MepV; the Netherlands runs a payment-pathway map anchored in the NZa Wegwijzer bekostiging digitale zorg and the Zorginstituut Nederland Handleiding Beoordeling digitale en hybride zorg (March 2025).

Two framings to reject:

1. “Europe is one market.” It is not, for DTx reimbursement. The MDR harmonises the regulatory floor; reimbursement stays national. EU HTA joint clinical assessments apply to a narrow scope and have no general effect on DTx pathways as of 2026.
2. “DiGA is a fast track.” It is the single most tractable European pathway, but the “twelve weeks at BfArM” is a feature of the review clock – not the cost or the study or the CE mark or the TR-03161 per-DiGA certification. For a foreign team starting from zero, 12–24 months project start to listing is the honest range.

The inbound story – foreign DTx companies entering Germany via DiGA

The inbound direction is where this knowledge area earns its place, because the existing public literature on DiGA is written by and for German regulatory specialists for German applicants. The foreign-applicant problem shape is different in five specific ways.

1. Legal manufacturer as the first decision, not the last. Non-EU teams almost always discover the legal-manufacturer constraint after they have scoped product and evidence. The correct sequence is the reverse. DiGAV § 2 requires the applicant to be the CE-marked medical-device manufacturer under MDR (DiGAV § 2↗). MDR Art. 11(1) requires a non-EU manufacturer to designate a sole authorised representative established in the EU; Art. 11(5) makes that representative jointly and severally liable for defective devices where the manufacturer has not complied with Art. 10 (MDR Art. 11↗). Three realistic routes exist – EU subsidiary, partnered legal manufacturer, acquisition of an EU medical-device company – and each has distinct tax, liability, and operational consequences.

2. German localisation is not translation. BfArM treats localisation as part of the review – UI, patient-education content, consent language that matches German medical law, clinical terminology aligned with German coding systems, and customer support in German. “Machine-translated UI” fails the review.

3. EU data residency resolves doubt. DiGAV § 4 para. 3 permits processing in Germany, EU member states, EEA-equivalent countries, and third countries with a European Commission adequacy decision (DiGAV § 4↗) – the latter includes the United States under the EU-US Data Privacy Framework. US-region hosting is therefore legally possible, but the practical advice is unanimous: EU-region hosting (AWS Frankfurt, Azure Germany, or comparable EU services with C5 or equivalent attestation) materially simplifies BfArM review.

4. BSI TR-03161 has no foreign equivalent. FDA’s 2026 premarket cybersecurity guidance is closer than any other non-German framework, but it assesses cybersecurity as a submission-quality factor under § 524B of the FD&C Act, not as a product-level certificate. BSI TR-03161 is certified per DiGA, not per company, against a testable catalogue with OWASP references and mandatory penetration testing by accredited test labs. Teams that “get to” TR-03161 after a year of development typically rebuild half the backend.

5. ePA integration is statutory. DiGAV § 6a and § 355 para. 2a SGB V require DiGAs to transfer data into the ePA (elektronische Patientenakte – Germany’s electronic health record) under § 341 SGB V, with six-month update windows when the semantic specifications evolve (DiGAV § 6a↗). No other European DTx pathway ties this tightly to a national EHR.

Beyond these five structural items, the inbound story has a commercial texture that is more important than the regulatory texture. Germany covers roughly 73 million statutorily insured lives under a single reimbursement decision. As of end-2025 the directory held 58 reimbursable DiGAs; since the pathway opened in late 2020, statutory insurers have dispensed approximately 1.6 million DiGA prescriptions at a cumulative cost of roughly €400 million; 2025 alone saw nearly 700,000 prescriptions at about €171 million (GKV-Spitzenverband DiGA Report 2025; SVDGV DiGA Report 2025). The entry anchor for this hub is Market Access Germany – the International DTx Company’s Guide to DiGA.

The outbound story – German and DACH companies expanding across Europe and emerging markets

A German company with a listed DiGA has the strongest European evidence anchor available – but the listing does not port. Each target market applies its own assessment against its own evidence bar.

France – PECAN. The structurally closest analogue to DiGA. Codified in Art. R162-112 to R162-121 of the Code de la sécurité sociale, with the HAS CNEDiMTS commission publishing its September 2025 principles of evaluation for early-access reimbursement within a statutory one-year window. PECAN is the closest functional match to DiGA and the most evidence-transferable outbound target for a DiGA listing.

Belgium – mHealthBelgium. A three-tier validation pyramid (M1 listing, M2 validated, M3 reimbursed) coordinated between the FAMHP (medical-device regulator) and NIHDI/INAMI/RIZIV (statutory insurance). M3 is indication-specific; reimbursement is not pathway-uniform.

The UK – DTAC and NICE ESF. Two separate mechanisms that teams often conflate. NHS DTAC is an assurance framework – clinical safety, data protection, technical security, interoperability, and usability/accessibility – that applies alongside, not in place of, other approvals. NICE ESF (ECD7) sets the evidence bar for digital health technologies. Neither is reimbursement – NHS digital therapeutics funding sits with regional Integrated Care Systems.

Switzerland – MepV. Switzerland is not MDR-native; Swiss market access requires conformity under the Medical Devices Ordinance MepV (SR 812.213) plus a CH-REP authorised representative. Reimbursement for digital therapeutics is at the discretion of individual health insurers under KVG – no statutory DTx pathway exists as of 2026.

The Netherlands – NZa/Zorginstituut. Dutch payment pathways for digital and hybrid care are mapped in the NZa Wegwijzer bekostiging digitale zorg 2026, with evaluation guidance from Zorginstituut Nederland’s Handleiding Beoordeling digitale en hybride zorg (March 2025). This is a payment-pathway framework, not a single-decision reimbursement route.

Nordic markets, Austria, Italy, Spain. No DTx-specific reimbursement framework of the German, French, or Belgian type exists in 2026. Individual products are reimbursed through existing care-pathway mechanisms or regional payer negotiations.

Emerging markets and Japan. Japan runs a DTCA (digital therapeutics) reimbursement framework under PMDA that is structurally closer to DiGA than anything elsewhere in APAC. Other APAC markets (Korea, Australia, Singapore) are moving toward DTx-specific frameworks without arriving.

The operative outbound insight: evidence de-risks sequence, not the file. A German DiGA’s comparative study does not short-circuit any of the above reviews, but it raises the prior probability that the French, Belgian, or Swiss decision-maker will take the file seriously. Sequence matters. The EU DTx Market Map 2026 cluster article compares ten countries head-to-head.

Three structural facts about EU DTx markets

1. No harmonisation of reimbursement

CE marking under MDR is harmonised across the EEA. HTA is harmonising for a narrow scope of high-risk medical devices and medicines under Regulation (EU) 2021/2282 from January 2025 – joint clinical assessments apply to specified categories, and most DiGA-class software products fall outside that scope. Reimbursement remains national competence. Every EU market is a separate project.

This has two practical consequences. First, market entry is multi-project rather than single-project – budget, time, and evidence plan each need a per-country view. Second, regulatory portability is partial: MDR portability is near-total (a CE-marked product is a CE-marked product across the EEA, subject to country-specific surveillance), but reimbursement portability is approximately zero.

2. Differing reimbursement logics

Germany’s DiGA is a combined regulatory + reimbursement assessment with a mandatory clinical-evidence comparator. France’s PECAN is a time-bound early-access gate with a one-year evaluation window. Belgium’s mHealthBelgium is a tiered validation pyramid without a uniform reimbursement decision. The UK’s DTAC is an assurance framework that expressly does not replace reimbursement or regulatory approvals. The Netherlands is a payment-pathway map. Switzerland is at the discretion of individual insurers.

Teams that map their home-market mental model onto these assume structural similarity where there isn’t any. A US team arriving with an FDA 510(k) clearance and a CMS coverage conversation expects the regulatory and reimbursement gates to be separate – and finds them fused in Germany.

3. Country-specific evidence bars

A comparative RCT that satisfies BfArM under DiGAV § 10 is not automatically acceptable to HAS for PECAN, to NICE for ESF, or to Zorginstituut for its Handleiding assessment. The headline requirements overlap – registered protocol, pre-specified analysis plan, clinically meaningful endpoint, credible comparator – but each authority brings its own emphasis. The practical design rule: design once for the most rigorous bar on the sequencing plan (usually BfArM or NICE), publish registered, and adapt the dossier per market rather than re-running the study.

Where DUX fits – platform partner for both directions

DUX Healthcare operates the mHealth Suite — a platform with 80+ pre-validated software modules for building and operating CE-marked DiGAs. Five DiGAs are currently under contract and being developed on the platform: platform-engineered, each individually tested against BSI TR-03161 per DiGA, all CE-marked under MDR. The software-development lifecycle is certified under BSI TR-03185; DUX is the first company in Germany to hold that certification.

For inbound work, the platform compresses Phase 1 of a DiGA file (project start to a DiGAV-compliant, CE-marked product) from 9–18 months (custom build) to about twelve weeks – not because the work is “faster”, but because the requirements DiGAV places on every DiGA are shared infrastructure rather than per-project rebuilds. The platform pairs with a legal-manufacturer partnership through a certified EU-based partner, so the two heaviest inbound blockers (engineering to DiGAV/MDR/TR-03161 bar, and the EU-manufacturer requirement) are solvable together rather than serially.

For outbound work, the platform is the substrate on which a German DiGA expands into adjacent markets: the MDR technical file, the IEC 62304 lifecycle artefacts, the data-protection architecture, and the evidence infrastructure reuse across national files. What does not reuse is national localisation, national evidence-adaptation work, and national legal/commercial structure.

For investors evaluating DUX, see /investors/. For a DTx team scoping its own work, the operative question is simpler: what does the sequence look like, and is the platform the right substrate for it?

Frequently asked questions