The European Commission (EC) has missed a key milestone in the rollout of EUDAMED, the central database for medical devices in the EU. According to the previously published timeline, EUDAMED was expected to be declared “fully functional” by July 1, 2025. However, with that date now passed and no notice published in the Official Journal of the European Union (OJEU), the official timeline remains unmet.
EUDAMED Timeline Status: Still Waiting for an Update
Despite the delay, the EC has not yet released a revised version of the EUDAMED Rollout Timeline. As of now, the most recent published version still reflects the original deadlines. Stakeholders should stay alert for an official communication or schedule update from the EC in the coming weeks.
Original Timeline (As Published):
Expected “Fully Functional” declaration: July 1, 2025
Start of mandatory use for four key modules: Based on the six-month transition period following the fully functional notice.
Updated Expectations: A Three-Month Shift
While there is no formal announcement yet, industry sources suggest the launch of the first four mandatory EUDAMED modules may be delayed by approximately three months. This would impact the timeline for key reporting obligations, including:
- Mandatory UDI Reporting
New expected start date: March 31, 2026
New expected end date: September 30, 2026
Revised (Expected) Rollout Timing:
The delay could adjust the entire cascade of EUDAMED compliance steps, pushing regulatory planning and IT integration forward accordingly.
At LexisNexis Reed Tech, we’re closely tracking every update from the European Commission so you don’t have to. With the EUDAMED rollout likely shifting by up to three months, now is the perfect time to ensure your organization is prepared. Our Medical Device UDI solution is designed to simplify your compliance journey—offering scalable, audit-ready tools that align with the latest EU regulatory requirements.
Whether you’re just starting your EUDAMED strategy or fine-tuning your data processes, we’re here to help you stay compliant and confident. From structured data submission to seamless integration with your internal systems, our experts have you covered—every step of the way.
Don’t wait for the next deadline—partner with LexisNexis Reed Tech today and stay ahead of EUDAMED.
Schedule a consultation to learn how we can support your compliance goals.
Achieve EUDAMED Compliance with LexisNexis Reed Tech. Download our whitepaper for key deadlines, strategies, and insights.
