What is EUDAMED?

EUDAMED is the European database for medical devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. It is intended to track the safety and performance of medical devices in accordance with the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR).

EUDAMED is accessible to competent authorities as well as economic operators who are registered in accordance with the MDR and IVDR. Economic operators include:

• Manufacturers
• Authorized Representatives
• Importers

The EUDAMED database consists of six interrelated modules:

1. Actor Registration – Enables economic operators (i.e., manufacturers, authorized representatives, and importers) to register their information
2. Unique Device Identification (UDI) – Maintains device-specific information. Economic operators are responsible for managing all UDI attributes and transferring the data to EUDAMED
3. Certificates – Maintains EU certificates for each product group
4. Clinical Investigation – Maintains information regarding the collection and analysis of clinical data
5. Vigilance – Maintains serious incident reports
6. Market Surveillance – Maintains post-market surveillance reports

*Source: The Essential Guide to EU MDR Compliance