A DTx manufacturer listed in Germany has answered two questions in one – this is the German specificity: The BfArM decision under § 139e SGB V combines regulatory eligibility assessment and entry into statutory health insurance reimbursement in one decision for about 73 million statutorily insured individuals. Other countries are building comparable structures: France with PECAN, Belgium with mHealthBelgium M3. The UK has assessment and assurance frameworks in NICE ESF and DTAC, but no DiGA-like reimbursement pathway. Add to that established non-EU regimes with their own regulatory pathways: US (FDA SaMD), Switzerland (MepV + CH-REP + Swissmedic).
Your DTx remains yours – you remain the manufacturer. As DTx Operations Partner, DUX contributes platform, operations and regulatory support, as in Build. Internationally, DUX is in market entry. The cost structure stays the same: predictable monthly cost instead of a flat licence per market. No cost or process break when transitioning from Build to Scale.
What distinguishes Scale from Go Beyond. In markets without statutory DTx reimbursement there is no structural way to feed a DTx into the healthcare system as an ongoing subscription. For these markets DUX is building the DTx Distributor model: national re-implementation, approval and ongoing operations – analogous to a pharma distributor, compensated via revenue share. That is Go Beyond, currently in exploration. Scale is for structured regulated markets – whether with DiGA-adjacent statutory reimbursement (DE, FR, BE), with their own national assessment and reimbursement routes (UK, CH) or with an established regulatory regime and diverse payer structures (US: commercial insurers, Medicare, employers).
CE marking under MDR is portable EU-wide. Switzerland runs separately under MepV (CH-REP, Swissmedic) on a CE basis. In Great Britain, CE-marked devices under EU MDR can currently be placed on the market until 30 June 2030 (as of October 2026). The US runs via its own FDA pathways (510(k), De Novo, PMA depending on risk class, 21 CFR 820). Reimbursement remains national and structurally heterogeneous – but the platform carries reusable components: the MDR file and study results are the starting material. France (CNEDiMTS, ANS conformity certificate) and Belgium (INAMI/RIZIV, ICT criteria) assess independently.
