Eudamed database: Registration as economic operator possible from 01.12.20

2020, December 1st, the European Commission opens the Economic Operator Registration Module available for manufacturer and other parties to Member States and economic operators.

Eudamed is the database that was developed by the European Commission to implement certain requirements of the Regulation (EU) 2017/745 on medical devices (MDR) and the Regulation (EU) 2017/746 on IVDs.

The Eudamed database will finally consist of six interconnected modules:

1. registration of economic operators (1 December 2020)
2. UDI/Product Registration (May 2021)
3. notified bodies and certificates (May 2021)
4. clinical studies and performance studies
5. vigilance and post-marketing surveillance
6. market surveillance

Author(s) Source
EU European Comission EUDAMED
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