Germany · Federal Institute for Drugs and Medical Devices · Software as a medical device
Review target
91 days
law
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
€3,000
2026
Digital care applications can be listed by BfArM so that long-term care insurance can pay for them. The manufacturer applies electronically and shows safety, quality, data protection and a care benefit. BfArM decides within three months of a complete application. A price is then agreed with the long-term care insurers within three months after listing. Digital applications for people in need of long-term care that seek payment by long-term care insurance.
The official review target is 91 days (law). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The dipa listing decision: range 3,000 to 9,900 euros (amount shown is the minimum) is €3,000 for 2026.
1. Electronic application to BfArM; 2. Assessment and decision (91 days); 3. Price agreement (91 days).
Outcome: Listing in the DiPA directory and a negotiated price.
Legal basis: Sozialgesetzbuch XI §§ 40a, 78a; Digitale Pflegeanwendungen-Verordnung (DiPAV)
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 182 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetlaw. About 3 months after a complete application. This is an official target in the law, not an actual review time. | 91 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| DiPA listing decision: range 3,000 to 9,900 euros (amount shown is the minimum)Application · 2026 | €3,000 |
Other routes in Germany: National requirements for CE-marked devices in Germany, Classification and legal status decision for devices, DiGA fast track: listing of digital health applications for reimbursement. See all routes on the Germany page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.