EUDAMED: Mandatory use of first four modules from May 28, 2026

EUDAMED, the European Database on Medical Devices, is the central IT platform established under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to enhance transparency, traceability, and coordination between EU Member States. It provides structured access to information for healthcare professionals, regulators, and the public.

EUDAMED consists of six modules:

1. Actor registration
2. Unique Device Identification (UDI) and device registration
3. Notified Bodies and certificates
4. Clinical investigations and performance studies
5. Vigilance and post-market surveillance

6. Market surveillance

    

With the publication of Regulation (EU) 2024/1860 on July 9, 2024, the EU introduced a gradual, module‑by‑module roll‑out of EUDAMED. Previously, most modules were available for voluntary use only, but would be made obligatory once functional.

On November 27, 2025, the European Commission published the Commission Decision (EU) 2025/2371, confirming that four EUDAMED modules are now fully functional.
 

These modules are:

1  Actor registration
2  Unique Device Identification (UDI) and device registration
3  Notified Bodies and certificates
6  Market surveillance 

Thus, this publication triggered a six‑month transitional period, after which these four modules become mandatory as of May 28, 2026. This marks a major milestone for transparency and device traceability in the EU regulatory framework.

Below is an overview of the key deadlines relevant to manufacturers and Notified Bodies, based on the confirmed full functionality and transitional rules set out in Regulation (EU) 2024/1860.
 

May 28, 2026 (6 months after OJEU publication)

Mandatory use of:

• Actor registration module
• UDI and device registration module

This means manufacturers must:

• register as economic operators (SRN), and
• register new devices placed on the market after this date.
   

November 28, 2026 (12 months after OJEU publication)

Completion of:

• the registration of Regulation devices (MDR/IVDR), and
• legacy devices placed on the market before the mandatory use of the module.

May 28, 2026 (6 months after OJEU publication)
Begin entering certification information into the EUDAMED “Notified Bodies & Certificates” module on an ongoing basis.

May 28, 2027 (18 months after OJEU publication)
Notified Bodies need to ensure that all relevant information about certification is registered in EUDAMED for which it has issued certifications before the use of module became obligatory.