EUDAMED – European Database on Medical Devices
EUDAMED is the EU’s central IT system for medical devices, created under the Medical Device Regulation (MDR 2017/745) and the In Vitro Diagnostic Regulation (IVDR 2017/746). It serves as a European-wide database that collects and shares information on medical devices, manufacturers, clinical investigations, vigilance, and market surveillance.
The goal of EUDAMED is to increase transparency and improve traceability of devices placed on the EU market. It supports regulatory authorities, healthcare professionals, and the public by providing access to key safety and compliance data—such as Unique Device Identifiers (UDIs), certificates issued by Notified Bodies, and post-market surveillance reports.
Once fully implemented, EUDAMED will have six interconnected electronic modules:
- Actors’ registration
- UDI/device registration
- Notified Bodies and certificates
- Clinical investigations and performance studies
- Vigilance and post-market surveillance
- Market surveillance
