What is EUDAMED?
EUDAMED is the IT system developed by the European Commission to implement MDR Regulation (EU) 2017/745 on medical devices and IVDR Regulation (EU) 2017/746 on in vitro diagnostic medical devices.
EUDAMED will improve transparency and coordination of information regarding medical devices available on the EU market. The system will be multipurpose. It will function as a registration system, a collaborative system, a notification system, and a dissemination system (open to the public) and will be interoperable.EUDAMED is structured around 6 interconnected modules and a public website:
- Actors registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
The module on Actor registration will be the first module made available. The deployment of the module is planned for December 2020. The first module will be on the Economic Operator (EO) registration and will be on a voluntary basis. The EO’s are manufacturers, system/procedure pack producers, authorized representatives, and importers.
It is important to start the registration of EO as soon as the system is available (currently planned for December 2020), for the reason that the EO’s need an SRN (Single Registration Number). Only if you have an SRN it will be possible to utilize other EUDAMED modules and to apply for conformity assessment. The advantage to undertake voluntary EO registration now is that manufacturers can wait without time pressure on the validation of the registration by the competent authority (CA). The EUDAMED modules on device& UDI registration and on certificates & notified bodies are planned to be launched by May 2021.