--- title: The DiGA Fast-Track Process: Reimbursement in Germany description: The DiGA fast-track process offers provisional BfArM listing with later permanent listing. Honest look at evidence, timelines, and pitfalls. authors: Tibor Zechmeister, Felix Lenhard category: Digital Health, DiGA & Health IT primary_keyword: DiGA fast-track process canonical_url: https://zechmeister-solutions.com/en/blog/diga-fast-track-process source: zechmeister-solutions.com license: All rights reserved. Content may be cited with attribution and a link to the canonical URL. --- # The DiGA Fast-Track Process: Reimbursement in Germany *By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.* > **The DiGA fast-track process is Germany's BfArM-managed pathway that allows a CE-marked digital health application to enter the reimbursable directory on a provisional basis while the manufacturer generates the clinical evidence needed for permanent listing. The marketing story is "three months to reimbursement". The reality, as reported by manufacturers Tibor has spoken with, is slower, harder, and more evidence-intensive than the headline.** **By Tibor Zechmeister and Felix Lenhard.** ## TL;DR - The DiGA fast-track process has two listing tiers: provisional listing for manufacturers still generating evidence, and permanent listing for those who have demonstrated positive healthcare effects . - BfArM administers the assessment and, according to public guidance, aims to issue a decision within approximately three months of a complete application . - CE mark under MDR is a precondition. BfArM does not assess the medical device conformity. That assessment is notified body territory, where relevant, or manufacturer self-declaration under Article 52 for Class I software. - The evidence bar for permanent listing is higher than most Class I self-certified manufacturers expect. Tibor has heard this repeatedly from DiGA-approved manufacturers. - Tibor has not walked a product through DiGA himself. Every fast-track-specific claim in this post is flagged for verification by founders with first-hand BfArM experience. - The "three months" headline is real but misleading. The work before submission is the expensive part. ## Why the fast-track story caught on Tibor hears the same opening line from founders looking at the German market: "We heard DiGA is a three-month fast-track to reimbursement." The sentence is technically anchored in something real, specifically the BfArM target decision window, but it skips over everything that has to happen before the BfArM clock even starts. Felix has watched this pattern across more than forty startup coaching engagements. A reimbursement headline number becomes a strategic assumption. The strategic assumption drives a product and regulatory sequencing decision. Six months later the founder discovers that the three months does not include the eighteen months of clinical evidence generation that should have preceded it. The right way to read the fast-track is as an access mechanism for products that have done the upstream work, not as a shortcut around the upstream work. ## The two-tier structure The DiGA framework distinguishes between two listing states. Founders who plan for only one of them tend to be surprised by the other. **Provisional listing.** A manufacturer whose product has a CE mark and who can credibly show a plan for demonstrating positive healthcare effects can apply for provisional listing. During the provisional period the manufacturer runs a study that generates the evidence BfArM requires for permanent listing. The DiGA is reimbursable during the provisional period . **Permanent listing.** After the provisional period, the manufacturer submits the generated evidence to BfArM. If the evidence demonstrates the required positive healthcare effects, the DiGA moves to permanent listing. If it does not, the DiGA is removed from the directory . The logic is that the German regulator wanted to avoid the usual reimbursement trap where an innovative digital health product cannot generate revenue until it has evidence, but cannot generate evidence until it has revenue and real-world users. Provisional listing breaks the deadlock. That is the theory Tibor understands from the public framework. What Tibor has also heard from manufacturers who walked the path is that the theory and the reality diverge in predictable ways. Provisional listings that fail at the permanent-listing review cost a manufacturer time, money, and public credibility. The provisional route is not a place to figure out what your product does. It is a place to prove what you already know your product does. ## What evidence BfArM actually wants Tibor is explicit that he is not the right source for the fine detail of BfArM evidence expectations. What he can say, from conversations with multiple DiGA-approved manufacturers, is that the evidence bar sits above minimal MDR Class I clinical evaluation. BfArM is looking for demonstrated positive healthcare effects. In the DiGA context this phrase covers : - improved patient-relevant clinical outcomes - improved quality of life or patient autonomy - reduced care burden - improved care coordination or efficiency of care delivery - quantitative evidence of cost, time, or resource savings to the German healthcare system A manufacturer whose clinical evaluation under MDR Article 61 addresses safety, performance, and acceptable risk-benefit is on solid MDR ground. A BfArM reviewer looking at the same package is likely to ask a different set of questions: what outcome improved, by how much, in what population, compared to what standard of care, measured how. The overlap between the MDR evidence package and the DiGA evidence package is real but partial. From Section 4 of Tibor's follow-up interview: "What needs to be shown is not only that the device works as intended but also that there is a positive benefit to the German healthcare system." Felix's sequencing advice follows directly. Founders who plan the clinical evaluation under MDR Article 61 and Annex XIV Part A with DiGA in mind from day one tend to save months later. Founders who plan the clinical evaluation purely to satisfy the CE mark and add DiGA afterwards almost always find themselves rebuilding study designs to generate BfArM-grade evidence. EN ISO 14155:2020+A11:2024 is the relevant clinical investigation standard where a formal investigation is run. BfArM expectations on study design, randomisation, control groups, and endpoint selection should be verified directly with the current DiGA guidance rather than assumed from general MDR practice. ## How the three-month fast-track actually works The three-month window refers to BfArM's target decision period after receipt of a complete application. "Complete" is the word founders underestimate. A complete application, according to public BfArM guidance, includes : - proof of a valid CE mark under MDR - a description of the digital health application and its intended purpose - evidence demonstrating the requirements for data protection, information security, interoperability, quality, and usability - an evidence package addressing positive healthcare effects, either demonstrated (for permanent listing) or planned (for provisional listing) - the manufacturer's proposed reimbursement pricing and supporting rationale Manufacturers who submit an incomplete application do not get a three-month decision. They get a completeness request, and the clock either does not start or resets. The real fast-track is short only for applicants who have done the preparatory work. Tibor's framing, drawn from MDR experience rather than DiGA experience specifically: the patterns are identical to notified body submissions. An auditor or an assessor is not going to find evidence that does not exist. What they will find is gaps, inconsistencies, and missing trace links between claim and source. A three-month BfArM review can become a nine-month BfArM conversation if the underlying package is weak. ## The economic reality behind the fast-track Tibor has heard two patterns from DiGA-approved manufacturers that founders rarely see in the marketing materials. **Pattern one: the reimbursement rate trajectory.** The initial negotiated rate tends to be acceptable. Over time, as the manufacturer enters structured rate negotiations with the statutory insurers, rates tend downward. Some DiGA manufacturers have reported that the out-year economics become unviable . A founder who models only the first-year rate in their business plan is setting themselves up for a painful year-two conversation. **Pattern two: the commercial pull problem.** Listing in the DiGA directory makes reimbursement legally possible. It does not automatically create physician awareness, patient demand, or insurer enthusiasm. Several DiGA-approved manufacturers have told Tibor that the commercial effort required after listing was larger than the regulatory effort required before listing. The directory is a necessary but not sufficient condition for German revenue. ## The Subtract to Ship playbook for DiGA fast-track Felix's sequencing for founders who are seriously considering the DiGA path: **Step one: decide DiGA before you design your clinical evaluation.** Waiting until after CE mark to decide DiGA almost guarantees rework on the clinical evidence package. Design the study with BfArM-grade endpoints from the start. **Step two: get the CE mark done cleanly.** Class I self-certification under MDR Article 52 requires a real quality management system to EN ISO 13485:2016+A11:2021, a real risk file to EN ISO 14971:2019+A11:2021, and a real software lifecycle to EN 62304:2006+A1:2015. Shortcuts here create BfArM questions later. **Step three: generate the evidence with a study design you would submit to permanent listing.** Do not treat provisional listing as a chance to figure out what works. Treat it as the final chance to prove what you already believe works. **Step four: model the reimbursement trajectory across five years, not one.** Build the business case against the declining rate, not the entry rate. If the business still works, DiGA is a rational move. If it only works at the entry rate, DiGA is a trap. **Step five: talk to at least three manufacturers already in the directory before you commit budget.** Tibor's single strongest piece of advice in Section 4 of the follow-up interview was to get real advice from founders who walked the path, not theoretical advisors who never submitted to BfArM. ## Reality Check 1. Do you have a valid CE mark under MDR, or a credible plan to get one before BfArM submission? 2. Does your clinical evaluation generate BfArM-grade evidence or only MDR-minimum evidence? 3. Do you know the difference between provisional and permanent listing and which tier you are targeting first? 4. Have you assembled the data protection, information security, interoperability, quality, and usability evidence BfArM expects? 5. Have you modelled the reimbursement rate decline over at least five years in your business plan? 6. Do you have a commercial plan for physician awareness, patient acquisition, and multi-insurer relations after listing? 7. Have you spoken to at least three DiGA-listed manufacturers about their real experience? 8. Are you using the "three-month" headline as a planning input, or as a hope? ## Frequently Asked Questions **Is the DiGA fast-track really three months?** The three-month figure is BfArM's target decision window on a complete application. It does not include the pre-submission work, which is typically the longer phase. Founders should plan around readiness, not the stated review window . **Can we apply for permanent listing directly without going through provisional?** Yes, if the clinical evidence is already generated at the time of submission. Permanent listing is not gated by provisional listing. It is gated by evidence . **What happens if the provisional study fails?** BfArM removes the DiGA from the directory. Reimbursement ends. The manufacturer can in principle redesign, generate new evidence, and reapply, but the public reputational cost is real . **Is the fast-track available to non-German manufacturers?** In principle yes, provided the product has a valid CE mark and meets the DiGA-specific requirements. Non-German manufacturers typically need local representation for practical reasons including GDPR data controller clarity and German-language documentation. **What is the biggest mistake Tibor has seen on DiGA attempts?** Founders who assumed DiGA approval would substitute for strong MDR clinical evaluation and ran into BfArM evidence requests they had no plan to satisfy. The fix is to treat DiGA evidence planning as part of CE mark evidence planning, not a downstream add-on. ## Related reading - [What is a DiGA?](/blog/what-is-diga-germany-framework) for the framework-level primer on DiGA, DVG, and BfArM. - [DiGA requirements in 2026](/blog/diga-requirements-2026) for the technical, data protection, and interoperability layer. - [Clinical evaluation for SaMD](/blog/clinical-evaluation-samd) for the MDR-side evidence foundation DiGA builds on. - [German reimbursement for medical devices](/blog/german-reimbursement-medical-devices) for the wider German reimbursement landscape. ## Sources 1. Regulation (EU) 2017/745 on medical devices, consolidated text. Article 52, Article 61, Annex VIII Rule 11, Annex XIV Part A. 2. Tibor Zechmeister, follow-up interview Round 2, Section 4 (DiGA), 11 April 2026. Tibor has not personally taken a product through the DiGA fast-track and defers to founders with first-hand BfArM experience for process-specific claims. 3. 4. 5. EN ISO 14155:2020+A11:2024. Clinical investigation of medical devices for human subjects. Good clinical practice. --- *This post is part of the [Digital Health, DiGA & Health IT](https://zechmeister-solutions.com/en/blog/category/digital-health) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*