Germany · Federal Institute for Drugs and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
1 requirements
Application fee
€400
2026
BfArM decides on the risk class of a device, on special class I categories, and on whether a product is a medical device or an accessory. It also settles disputes on classification between a manufacturer and its notified body. A request can come from a state authority, or from a manufacturer, authorised representative or notified body based in Germany. The law says BfArM should decide within three months. Unclear classification or borderline status, for example for software or products near the medicine boundary.
The decision on classification or legal status: range 400 to 1,000 euros (amount shown is the minimum) is €400 for 2026.
1. Submit the request; 2. Decision by BfArM (91 days).
Outcome: A binding decision on class or legal status.
Legal basis: Medizinprodukterecht-Durchführungsgesetz (MPDG) § 6
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 91 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
| Decisionlaw. The law says the authority should decide within about 3 months. This is an official target in the law, not an actual review time. | 91 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Decision on classification or legal status: range 400 to 1,000 euros (amount shown is the minimum)Other · 2026 | €400 |
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, DiGA fast track: listing of digital health applications for reimbursement, 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.