Have you already read our FAQ?
We have detailed answers to the most frequently asked questions in our FAQ section on medical devices (available in german only).
Your question has not been answered yet?
Then please write us via the BfArM's contact form - this will give us the possibility to read, research and answer your question in detail.
You want to reach us by telephone or email?
In the following you will find contact information on various subjects.
Demarcation / Classification of medical devices
Risk assessment / incident assessment
Contact form risk assessment
Non-active medical devices
Telephone: +49 (0)228 99 307-3202
Active medical devices
Telephone: +49 (0)228 99 307-5384
In vitro diagnostics (IVD)
Telephone: +49 (0)228 99 307-5384
Clinical investigations (CI) / performance evaluations (PE) of active medical devices and/or IVD
Contact form CI/PE
Hotline: Mondays, Tuesdays and Thursdays from 9 to 11:30 p.m.
Telephone: +49 (0)228 99 307-5999
DMIDS: German Medical Devices Information and Database System
Contact form DMIDS
Office hours: Monday to Friday from 9am to 1pm CEST
Telephone: +49 (0)228 99 307-4943
DMIDS public: flat fees, prices
Special Authorisation of Medical Devices
Contact form special authorisation
Non-active medical devices
Telephone: +49 (0)228 99 307-3202
Active medical devices
Telephone: +49 (0)228 99 307-5384
In vitro diagnostics (IVD)
Telephone: +49 (0)228 99 307-5384
Other inquiries regarding medical devices
