Germany · Federal Institute for Drugs and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
1 requirements
Application fee
€250
2026
Under the conditions of the EU device and IVD rules, BfArM can allow, on a justified application, the placing on the market or putting into service in Germany of a device that has not gone through the normal conformity assessment. BfArM informs the European Commission and the other member states. A device or IVD needed in Germany before it has completed the EU conformity assessment, under the conditions the EU rules set for such exceptions.
The special authorisation decision: range 250 to 10,300 euros (amount shown is the minimum) is €250 for 2026.
1. Submit a justified application; 2. Assessment by BfArM; 3. Decision; 4. EU notification.
Outcome: A national special authorisation for Germany only.
Legal basis: Medizinprodukterecht-Durchführungsgesetz (MPDG) § 7; Regulation (EU) 2017/745 Article 59; Regulation (EU) 2017/746 Article 54
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 |
|---|---|
| Special authorisation decision: range 250 to 10,300 euros (amount shown is the minimum)Application · 2026 · On request the fee can be cut to one quarter, or waived, for example when little economic benefit is expected, cases are rare, or there is a special public health interest. | €250 |
Other routes in Germany: Medicines authority consultation for devices with a medicinal substance, 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.