The European Database on Medical Devices (EUDAMED) is rapidly becoming an essential part of compliance in the EU’s medical device landscape. Designed to improve transparency, traceability, and patient safety, EUDAMED centralizes key data on medical devices sold across Europe. While this database’s full deployment has been delayed, the European Commission has now committed to a phased rollout, aiming for mandatory use by 2025 for several modules and 2027 for complete functionality.

Key Components of EUDAMED: What You Need to Know

The EUDAMED database is structured around six modules, each serving a different regulatory function:

1. Actor Registration: Active since late 2020, this module requires manufacturers, authorised representatives, and importers to register their details, ensuring visibility into the roles of each actor in the EU medical device market​

2. UDI/Device Registration: This module, which became available in 2021, manages the Unique Device Identifier (UDI) system. UDIs are crucial for device tracking and recall management, enabling traceability throughout the supply chain​

3. Notified Bodies and Certificates: This component is also live, allowing notified bodies to input certification data, which improves visibility into certified devices​

The remaining modules—Vigilance, Market Surveillance, and Clinical Investigations—are slated for rollout between 2025 and 2027. The Vigilance module, for example, will allow for real-time reporting and monitoring of adverse events, enhancing post-market safety.

Phased Rollout Timeline and Compliance Implications

According to the latest European Commission roadmap, the modules that are already operational will become mandatory by late 2025, giving businesses six months after each module's full functionality is announced. The rollout of the final Clinical Investigation and Performance Studies module will complete by 2027​

For manufacturers, this phased approach means that early compliance with the available modules is not only a best practice but will also help avoid last-minute rushes when mandatory deadlines arrive. Registering actors and devices early in EUDAMED ensures a smoother transition and prepares your company for future regulatory expectations.