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 with NICE ESF + DTAC. Add to that established non-EU regimes with their own regulatory pathways: US (FDA SaMD), Switzerland (MepV + CH-REP + Swissmedic).
In all of these markets your DTx remains yours; DUX takes over operations, regulatory work and market interface – as your DTx Operations Partner, as in Build. 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 emerging markets without statutory DTx reimbursement and often still-immature digital health regulation – LATAM, SEA, MENA, Sub-Saharan Africa – there is no structural way to feed the DTx as an ongoing subscription into the national healthcare system. There, DUX takes over national re-implementation, approval and ongoing operations as your DTx Distributor – analogous to a pharma distributor, compensated via revenue share. That’s the domain of Go Beyond. Scale is for structured regulated markets – whether with DiGA-adjacent statutory reimbursement (DE, FR, BE, UK), with their own national reimbursement pathways (CH), or with an established regulatory regime and diverse payer structures (US: Commercial, Medicare Advantage, VA, Employer).
CE marking under MDR is portable EU-wide. Switzerland runs separately under MepV (CH-REP, Swissmedic) on a CE basis. The UK accepts CE-marked medical devices until 30.06.2030. 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 the reusable components: DiGA evidence, BSI TR-03161 security posture and the MDR file are materially reusable in PECAN and mHealthBelgium M2/M3; for FDA SaMD the MDR file forms the substantive basis from which the FDA-specific documentation is drawn.
