BfArM - Federal Institute for Drugs and Medical Devices

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FAQ and contact persons

In the following you will find answers to the most frequently asked questions in the field of medical devices as well as contact information on various subjects.

FAQ

Contact persons

Have you already read our FAQ?
We have detailed answers to the most frequently asked questions in our FAQ section on medical devices.

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.
Contact information on various subjects:

Demarcation / Classification of medical devices

Contact form demarcation/classification

Telephone: +49 (0)228 99 307-3997

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: Technical helpdesk, flat fees, prices

Technical helpdesk: survey tool (in German language)

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

Contact form medical devices in general

Telephone: +49 (0)228 99 307-5325