BfArM - Germany Federal Institute for Drugs and Medical Devices

The Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte or BfArM) is the regulatory authority for German. Functioning as an independent body within the Federal Ministry of Health, the BfArM deals with the authorization of drugs of medical devices on the basis of the German Medicines Act (Arzneimittelgesetz, AMG), monitors legal trade of narcotics and evaluates the potential risk posed by medical devices.

The BfArM is divided into 9 departments, the 9th department being exclusively dedicated to medical device matters. Its main focus is the evaluation of incident reports and the authorization of clinical investigations on medical devices.

Major Regulations

Some of the most important European regulations for medical devices in the EU are:

A full list of EU regulations can be found here.

Contact details:

Medical Device Associations in Germany: