EUDAMED will be mandatory from 28 May 2026 Under EU MDR/IVDR What Manufacturers Must Do Now

A big change in Europe Medical devices is coming for every company who are placing medical devices or IVDs on the EU market. From 28 May 2026, the European Database on Medical Devices known as EUDAMED, becomes mandatory. If you are a manufacturer, authorized representative, importer, or distributor, you need to be ready before due date. Non-compliance can directly impact market access and revenue continuity. 

What is EUDAMED and why is it mandatory now 

EUDAMED is the European Commission’s central IT system built under Regulation (EU) 2017/745, the Medical Device Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). It brings together actor, device, certificate, and market surveillance data into one place. Until now, most of the modules were voluntary. The final gazette from the European Commission confirmed that four modules will become mandatory on 28 May 2026: 

• Actor Registration 
• UDI and Device Registration 
• Notified Bodies and Certificates 
• Market Surveillance and Vigilance (phased rollout) 

EUDAMED Deadlines you cannot miss 

These are the dates your regulatory team should have on the wall: 

• 28 May 2026: Actor registration and new device registration become mandatory for new device only on the market. 
• 27 November 2026: Devices already on the market must be registered in EUDAMED. 
• 28 May 2027: Legacy certificates issued before the mandatory date must be uploaded into the EUDAMED database

Critical Compliance deadlines can block shipments, delay tenders, and trigger competent authority queries. 

Ensure PRRC oversight for data accuracy and regulatory accountability 

1. Get your Single Registration Number (SRN). Without an SRN you cannot submit anything else. 
2. Including Basic UDI-DI alignment with technical documentation and certificates EUDAMED expects consistent trade names, Basic UDI-DIs, and packaging levels. 
3. Align technical documentation with EUDAMED fields. Many manufacturers still store data in spreadsheets and PDFs that do not map cleanly to the database. 
4. Coordinate with your Authorized Representative and Notified Body. Each party has different upload responsibilities.
5. Train your team on the EUDAMED user interface and especially for manufacturers managing large portfolios across multiple jurisdictions 

Where manufacturers get stuck 

From our recent client conversations, three pain points keep coming back.  

• Teams underestimate how long data cleansing takes for legacy devices.
• Groupings between trade names and Basic UDI-DIs need careful mapping.
• IVDR manufacturers often forget that performance evaluation data needs its own placeholder even when the study is still ongoing.
• Delays due to dependency on Notified Body certificate uploads and validation workflows 

What happens after 28 May 2026 

After 28 May 2026, post-market surveillance information will increasingly be handled through EUDAMED. Manufacturers will need to keep vigilance reports, Periodic Safety Update Reports (PSUR), serious incident reports, field safety corrective actions, and trend reporting records updated in the system. 

Competent authorities will shift from paper based checks to live EUDAMED queries. If your entries are incomplete or inconsistent, you will see holds on importer declarations and CE certificate renewals. Distributors in several member states may increasingly refuse devices that do not show a valid EUDAMED record. 

Final thought 

EUDAMED is not just another portal. It is the new public face of your regulatory compliance in Europe. Manufacturers that approach it as a data-governance initiative rather than simply an IT task will be better positioned to adapt quickly. It is a core part of regulatory digital transformation in the EU market. 

If you are unsure where to start, NexorTest Technologies can help you map your portfolio to EUDAMED fields, secure your SRN, and coordinate with your EU Authorized Representative. Visit www.nexortest.com to book a short scoping call.