Webinar: What Does an EUDAMED Project Represent?

The EUDAMED project is a game-changer for the medical device industry within the European Union. Compliance with the EUDAMED database is vital to ensure patient safety, enhance transparency, and meet strict regulatory demands. This webinar outlined the risks of non-compliance, such as marketing bans, and highlighted the benefits of a well-structured project approach.

With less than 12 months before the first EUDAMED deadline, manufacturers must act now. The webinar presented a clear timeline, explaining the requirements for devices placed on the market before and after January 2026, as well as specific deadlines for registering “Legacy” devices. Starting early is critical to avoid delays in data collection and validation.

EUDAMED is composed of six main modules: Actors, Devices (UDI/DEV), Notified Bodies and Certificates, Market Surveillance, Vigilance, and Clinical Investigation. The “Devices” (UDI/DEV) module is particularly critical as it represents the bulk of the workload for manufacturers. We provided detailed guidance on structuring data to meet this module’s requirements effectively.

A successful EUDAMED project relies on three main workstreams: data collection, publishing via suitable tools (including M2M solutions), and traceability of operations. Each step was analyzed, with practical recommendations on implementation, including the use of Ackomas Excel templates to simplify data collection.

Companies that have taken a proactive approach to EUDAMED compliance share encouraging results. The webinar highlighted key differences between EUDAMED and other databases, such as GUDID, and specific challenges like creating new UDI identifiers. These experiences offer valuable lessons to help structure your own projects effectively.