As part of the new MDR, the European Commission developed a secure database called EUDAMED to improve transparency and coordination of information regarding medical devices on the EU market.
The system is comprised of six modules:
- Actor Registration: Enables economic operators (i.e., manufacturers, authorized representatives, and importers) to register their information
- Unique Device Identification (UDI): Maintains device-specific information. Economic operators are responsible for managing all UDI attributes and transferring the data to EUDAMED
- Certificates: Maintains EU certificates for each product group
- Clinical Investigation: Maintains information regarding the collection and analysis of clinical data
- Vigilance: Maintains serious incident reports
- Market Surveillance: Maintains post-market surveillance reports
The Actor Registration module went live on December 1, 2020. Economic operators are encouraged to register with the system and obtain a single registration number (SRN) to meet the requirements of the regulation. The operation of all six modules is necessary for full MDR implementation and is scheduled for May 2022.