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BfArM
BfArM — Germany Medical Device Regulatory Authority
Germany
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 →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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