Germany · Federal Institute for Drugs and Medical Devices · Software as a medical device
Review target
91 days
law
Legal time limit
183 days
law
Steps
5
8 requirements
Application fee
€3,000
2026
CE-marked medical device apps of class I, IIa or IIb whose main function is digital can be listed by BfArM in the directory of digital health applications. Listed apps are paid for by statutory health insurance when prescribed or approved by the insurer. BfArM decides within three months of a complete application, extendable by three months. If the positive care effect is not yet proven, a low-risk app can be listed provisionally for up to twelve months while a study runs. Class IIb apps must show a medical benefit. Digital medical devices (class I, IIa or IIb) whose main function is digital and that seek reimbursement by statutory health insurance.
The official review target is 91 days (law). The legal time limit is 183 days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The diga listing decision: range 3,000 to 9,900 euros (amount shown is the minimum) is €3,000 for 2026.
1. CE marking as a medical device; 2. Electronic application to BfArM; 3. BfArM assessment and decision (91 days); 4. Provisional listing while evidence is generated (option); 5. Permanent listing.
Outcome: Listing in the DiGA directory (permanent or provisional for testing), which allows reimbursement.
Legal basis: Sozialgesetzbuch V §§ 33a, 139e; Digitale Gesundheitsanwendungen-Verordnung (DiGAV)
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 456 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 |
| Legal time limitlaw. Up to about 6 months when the deadline is extended in justified cases. | 183 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| DiGA listing decision: range 3,000 to 9,900 euros (amount shown is the minimum)Application · 2026 · On request the fee can be cut to one quarter when little economic benefit is expected, cases are rare, or the target group is small. | €3,000 |
Other routes in Germany: Medicines authority consultation for devices with a medicinal substance, National requirements for CE-marked devices in Germany, Special national authorisation for a device without CE marking, Classification and legal status decision for devices, Listing of digital care applications (DiPA). 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.