Germany · Federal Institute for Drugs and Medical Devices · Combination products
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
€5,000
2026
When a medical device contains a medicinal substance with an ancillary action, the notified body consults a medicines authority. When a notified body asks BfArM, its medicines departments assess the medicinal part. German national fees apply. The EU route describes the overall conformity assessment. Medical devices with an ancillary medicinal substance, when the notified body asks BfArM for the consultation.
The consultation opinion, new substance or known substance with new purpose: range 5,000 to 25,000 euros (amount shown is the minimum) is €5,000 for 2026.
1. Notified body requests the consultation; 2. Assessment of the medicinal substance; 3. Notified body decision.
Outcome: A scientific opinion to the notified body on the medicinal substance.
Legal basis: Regulation (EU) 2017/745 Article 52(9) and Annex IX Section 5.2; BMGBGebV
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Consultation opinion, new substance or known substance with new purpose: range 5,000 to 25,000 euros (amount shown is the minimum)Other · 2026 | €5,000 |
| Consultation opinion, known substance used in the usual way: range 2,500 to 10,000 euros (amount shown is the minimum)Other · 2026 | €2,500 |
Other routes in Germany: National requirements for CE-marked devices in Germany, Special national authorisation for a device without CE marking, 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 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.