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§ EUROPE
EMA
European Medicines Agency
European Union
The EMA coordinates the EU regulatory framework for medical devices under EU MDR 2017/745 and IVDR 2017/746. While Notified Bodies conduct conformity assessments, the EMA and European Commission set policy. The transition from MDD to MDR has fundamentally reshaped device regulation across 27 EU member states.
DEVICE CLASSES
Class I, IIa, IIb, III
APPROVAL PATHWAY
CE marking via Notified Body
KEY REGULATORY FUNCTIONS
- ▸EU MDR / IVDR framework coordination
- ▸EUDAMED database oversight
- ▸Notified Body designation support
- ▸CE marking pathway
- ▸Vigilance and post-market surveillance
OFFICIAL WEBSITE
https://www.ema.europa.eu →MedFlux monitors EMA regulatory changes, safety alerts, and market signals in real time — so your team never misses a critical update.
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