BfArM
BfArM — Germany Medical Device Regulatory Authority
Germany
Last reviewed 2026-06-21
BfArM is the national regulatory authority responsible for medical device oversight in Germany. It manages device registration, market surveillance, and adverse event reporting within the Europe regulatory framework.
DEVICE CLASSES
EU MDR classes
APPROVAL PATHWAY
BfArM registration
KEY REGULATORY FUNCTIONS
- ▸Device registration
- ▸Market surveillance
- ▸Adverse event reporting
- ▸Import/export control
OFFICIAL WEBSITE
https://www.bfarm.de →§ RELATED INTELLIGENCE
§ FAQ
What is BfArM in Germany?
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) is Germany's Federal Institute for Drugs and Medical Devices. It serves as the national competent authority for medical device market surveillance under EU MDR, manages the German device registration database, and coordinates vigilance reporting. BfArM does not issue CE certificates — that is the role of EU Notified Bodies.
MedFlux monitors BfArM regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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