Germany · Federal Institute for Drugs and Medical Devices · Medical devices
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
5 requirements
Application fee
-
Medical devices and IVDs reach the German market through EU conformity assessment and CE marking. German law adds national duties. Information for users and patients must be in German, with limited exceptions for professional users. Field safety notices are written in German. State (Länder) authorities supervise the market, while BfArM, or the Paul-Ehrlich-Institut for certain high-risk IVDs, assesses serious incidents centrally. Any CE-marked medical device or IVD made available in Germany.
1. EU conformity assessment and CE marking; 2. Provide German user information; 3. Vigilance reporting.
Outcome: The device can be supplied in Germany once the EU requirements and these national duties are met.
Legal basis: Medizinprodukterecht-Durchführungsgesetz (MPDG) §§ 4, 8, 71, 73, 85; Regulations (EU) 2017/745 and 2017/746
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 |
|---|---|
| No fees published. |
Other routes in Germany: Medicines authority consultation for devices with a medicinal substance, 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, 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 (7 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.