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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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