International Market Access – DTx Across Europe and Beyond on DUX Healthcare

Who Qualifies as DiGA Applicant – Legal Manufacturer Bar

Mon, 27 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 17 April 2026

“We built the product in Boston, we got our 510(k), and now we want to list it as a DiGA in Germany.” Some version of this sentence comes up regularly in inbound conversations, and the answer is almost never “that works”. Not because the product is wrong – but because the applicant named on a DiGA filing has to be the legal manufacturer of a CE-marked medical device under the MDR, and the MDR requires that legal manufacturer to be established in the EU, or to appoint an EU authorised representative who assumes specific legal duties. This is the applicant-identity question: a frequent reason foreign DTx teams stall on their German market-entry plan at month eight, because the entity that is supposed to sign the BfArM application does not exist yet and cannot be built in a quarter. This article walks through who qualifies, why non-EU companies hit a structural wall, what the three realistic routes into Germany look like, what they actually cost in weeks, and where teams consistently underestimate the work.

EU DTx Market Map 2026 – 10 Countries Compared

Mon, 27 Apr 2026 00:00:00 +0000

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.

DiGA vs FDA SaMD – What Translates, What Doesn't

Mon, 27 Apr 2026 00:00:00 +0000

By Christoph Eberhardt · CEO, DUX Healthcare · 17 April 2026

Most US DTx companies arrive at DiGA with an FDA mental model: a risk-based classification, a cleared device, a cybersecurity section in a premarket submission, and – separately, later, painfully – a reimbursement conversation with CMS, commercial payers, and employer-sponsored plans. That mental model is not wrong for the US. It is partially transferable to Germany, and the parts that do not transfer are the parts that matter most. A DiGA is not a German 510(k). It is a combined regulatory-and-reimbursement instrument, built on top of a European CE mark under the MDR, with clinical-evidence, cybersecurity, and data-protection bars that look superficially similar to the FDA regime and diverge in structure, scope, and legal weight. This article maps the two pathways for a US audience, flagging what transfers, what does not, and where the surprises sit.