BfArM promises a decision in three months. The real clock starts much earlier — with CE marking, a security certificate and, above all, a study — and the real money question is what happens to your price after month twelve.
The BfArM review itself is short: a decision within 3 months of a complete application. Before that you need MDR CE marking, a BSI TR-03161 certificate and, for permanent listing, a study showing a positive care effect. A provisional listing adds a trial phase of up to 12 months, extendable to 24. Realistically, plan 1.5 to 3 years from a CE-ready product to permanent listing. Official BfArM fees are in the low thousands of euros; the large costs are the clinical study, notified-body work and security certification. You set your price freely in year one (2025 average: EUR 544 per prescription); from month 13 a negotiated price applies — on average about 59% lower, at least 20% of it outcome-based.
| Stage | Typical duration | Main cost |
|---|---|---|
| MDR CE marking (class I, IIa or IIb) | Often 12–18 months if not yet done | Notified body (class IIa+), QMS, technical documentation |
| BSI TR-03161 certificate | Several months, plus fixes | Test lab: five-digit euro amounts per run |
| Study for a positive care effect | Trials ran 9–48 weeks, plus set-up and analysis | Usually the largest single item |
| BfArM review | 3 months from a complete file (can be extended by 3) | Fees in the low thousands |
| Provisional trial phase (class I/IIa only) | Up to 12 months, extendable to 24 | Evaluation by an independent institution |
| Price negotiation | Negotiated price applies from month 13 | Your revenue, not a fee |
These stages overlap in practice. There is no official end-to-end figure, but adding up what manufacturers report gives roughly 1.5 to 3 years from a CE-ready product to permanent listing — longer if CE marking and the study start from zero.
BfArM charges fees under the DiGA fee rules. According to the federal public-service description, the ranges are:
| Procedure | Fee range |
|---|---|
| Decision on listing | EUR 1,500 – 9,000 |
| Evidence for permanent listing after a trial | EUR 1,500 – 6,600 |
| Extension of the trial phase | EUR 1,500 – 4,900 |
| Notified changes | EUR 300 – 4,900 |
| Delisting | EUR 200 |
Fees can be reduced or waived where the economic value to the applicant is low. The BSI TR-03161 certificate is not a BfArM fee: it is paid to the testing lab and, by industry accounts, costs five-digit euro amounts per certification run. It is tied to a software version, so updates trigger maintenance procedures. A GDPR data-protection certificate is also required by law, but certification schemes have been late, and BfArM can set later deadlines.
Plan your business case on the negotiated price, not the launch price. For the patient and prescriber side, see DiGA: the app on prescription.
We track each step in the weekly Regulatory Digest.
BfArM decides within three months of a complete application. Before that you need CE marking, a BSI TR-03161 certificate and study evidence or an evaluation concept; a provisional listing then adds a trial phase of up to 12 months, extendable to 24. From a CE-ready product to permanent listing, plan roughly 1.5 to 3 years.
According to the federal service description, the listing decision costs EUR 1,500 to 9,000, evidence for permanent listing EUR 1,500 to 6,600, a trial extension EUR 1,500 to 4,900 and notified changes EUR 300 to 4,900. Fees can be reduced or waived in some cases.
There is no reliable published total. The largest items are the clinical study (usually an RCT), notified-body costs for class IIa and IIb (reported at roughly EUR 50,000 to 120,000 per device), BSI certification and ongoing outcome reporting. Official fees are a small share.
The manufacturer sets the price for the first 12 months; the 2025 average was EUR 544. From month 13 a negotiated price applies; the negotiated prices so far average about EUR 227, and at least 20% must be outcome-based since January 2026.
Yes. The 2024 Digital Act opened DiGA to class IIb, but only via permanent listing: the positive care effect must be proven at application, with no provisional trial phase.
A fixed-price Snapshot or Pathway & Role Map tells you whether DiGA is the right route for your product and what the realistic path to reimbursement looks like.