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July 1, 2025
EUDAMED Compliance Countdown: Are You Ready for The Deadline?
With the European Commission now having officially set the EUDAMED compliance dates, regulatory affairs teams across the medical device sector are feeling the pressure to get ready. The clock is ticking: organizing UDI data, staying aligned with the confirmed EU requirements, and proactively addressing potential challenges is now more important than ever to avoid last-minute compliance headaches.
EUDAMED Compliance Deadlines: Key Insights
The European Database on Medical Devices (EUDAMED) is a cornerstone of both the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). Its main objectives are to strengthen transparency, traceability, and patient safety across the European medical device market. As a result, manufacturers must meet specific deadlines for registering both new and existing devices in EUDAMED.
Deadlines for New Products
- Newly Launched Devices: All new medical devices and IVDs placed on the EU market under MDR or IVDR after mandatory EUDAMED use begins (28. May 2026) must meet UDI requirements and be registered in EUDAMED before they are marketed.
- Key Requirement: Manufacturers must assign a Basic UDI-DI and enter
device data into EUDAMED before placing the product on the EU market, once the relevant modules are mandatory.
Deadlines for Existing Products
- All Devices: Devices already placed on the market before the EUDAMED
application dates, that are still placed on EU market, fall under transitional provisions. These products must also be registered in EUDAMED (28. November 2026). - Legacy Devices placed on EU market under MDD/IVDD/AIMDD are
especially falling into that category. - Key Requirement: Manufacturers need to update UDI data, for among others, legacy devices and complete their registration in EUDAMED within the 12-month transition period from EUDAMED applicablity date (which started in November 2025 after publishing).
Timeline Overview
- 28. May 2026: Mandatory use of the core EUDAMED modules (Actor, UDI Devices, Notified Bodies & Certificates, Market Surveillance) will begin. Newly placed devices registrations become mandatory.
- 28. November 2026: Mandatory use of the core EUDAMED modules with special regard to all devices placed on the market prior to EUDAMED applicability becoming mandatory to register. Vigilance module go-live and mandatory usage.
Meeting these requirements will require careful planning and attention to detail, especially for UDI assignment, Basic UDI-DI management, and accurate data submissions.
How to Prepare for the Deadline
- Audit Your Data: Review your current UDI data for completeness and
consistency. - Optimize Processes: Consider digital tools and internal process reviews to support accurate data validation, submission, and monitoring.
- Stay Informed: Regularly check updates from the European Commission, EU UDI Helpdesk, and EUDAMED guidance documents for the latest requirements and interpretations.
By preparing now, manufacturers can avoid last-minute compliance issues and help ensure uninterrupted market access for their devices. Early action on data and processes is the best way to approach the upcoming EUDAMED deadline with confidence.