EUDAMED Modules Go Live: What EU Decision 2025/2371 Means For MDR & IVDR Compliance

After years of delays, phased development, and regulatory uncertainty, the European Commission has taken a decisive step toward full implementation of the European Database on Medical Devices (EUDAMED).

With the publication of Commission Decision (EU) 2025/2371, four core EUDAMED modules are now officially declared functional and mandatory under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

This decision represents a major regulatory milestone for manufacturers, Authorized Representatives, Notified Bodies, and other economic operators operating in the European Union. It introduces clear legal deadlines, establishes mandatory system usage, and significantly strengthens transparency, traceability, and market surveillance across the EU medical device landscape.

Why EUDAMED Was Released in Phases

When MDR (EU) 2017/745 and IVDR (EU) 2017/746 were first adopted, regulators envisioned launching all six EUDAMED modules simultaneously. However, the scale and technical complexity of the system made this approach impractical.

To address prolonged delays, Regulation (EU) 2024/1860 amended MDR and IVDR, allowing EUDAMED modules to become mandatory individually, once independently audited and verified as functional.

This legislative change paved the way for the publication of Decision 2025/2371, formally triggering compulsory use of the first four modules.

Commission Decision (EU) 2025/2371: Overview

Commission Decision 2025/2371 was published on 27 November 2025. The decision is concise but legally significant, consisting of:

• Six recitals
• Two binding articles

One of the most important confirmations appears in Recital 4, which states that the independent audit report verifying functionality was completed on 18 June 2025. This audit confirmation is the legal trigger that enables mandatory use.

The Four EUDAMED Modules Now Mandatory

Under Article 1 of Decision 2025/2371, the following four EUDAMED modules are declared functional and subject to compulsory use:

1. Actor Registration (ACT) Module

• Mandatory registration of manufacturers, Authorized Representatives, importers, and other economic operators
• Assignment of Single Registration Numbers (SRNs)
• Foundation for access to all other EUDAMED modules

2. UDI / Device Registration (UDI/DEV) Module

• Registration of device UDI-DI and core device information
• Applies to MDR and IVDR compliant devices
• Supports traceability and public transparency

3. Notified Bodies & Certificates (NB/CRF) Module

• Upload and management of certificates issued by Notified Bodies
• Improve oversight of conformity assessments
• Links certificates directly to registered devices

4. Market Surveillance (MSU) Module

• Centralized reporting for post-market surveillance and vigilance
• Covers PSURs, MIRs, FSCAs, trend reports, and other PMSV submissions

Mandatory EUDAMED Deadlines You Must Know

Decision 2025/2371 introduces clear and enforceable timelines depending on when devices are placed on the EU market.

Key Compliance Dates

• 28 May 2026
  • Mandatory use of ACT, UDI/DEV, NB/CRF, and MSU modules for new MDR- and IVDR-compliant devices
  • All economic operators must be registered in the Actor Module
• 27 November 2026
  • Deadline for registering legacy MDR/IVDR-compliant devices in the UDI/DEV module if placed on the market before 28 May 2026

Special Scenarios Manufacturers Must Consider

Actor Registration Is Mandatory First

Regardless of device status, Actor Registration (ACT) is a prerequisite. Manufacturers of legacy devices must register as actors no later than 28 May 2026.

Post-Market Surveillance Submissions

If a device is:

• Exempt from UDI/DEV registration but
• Subject to a post-market surveillance or vigilance submission (PSUR, MIR, FSCA, trend report)

Then:

The device must be registered in EUDAMED before submission once the Vigilance Module becomes mandatory.

This requirement directly links PMS compliance to EUDAMED readiness.

EUDAMED Module Obligations & Deadlines

What This Means for Manufacturers

Decision 2025/2371 transforms EUDAMED from a voluntary system into a regulatory obligation.

Manufacturers must know:

• Align internal regulatory processes with EUDAMED workflows
• Ensure data consistency between technical documentation and EUDAMED entries
• Prepare for increased public visibility of device information
• Strengthen coordination between regulatory, quality, and IT teams

Failure to comply with EUDAMED obligations may lead to:

• Regulatory non-compliance findings
• Delays in market access
• Post-market submission rejections
• Increased scrutiny during inspections

Strategic Preparation: How to Get Ready for Mandatory EUDAMED Use

1. Confirm Actor Registration Status

Ensure all legal manufacturers, ARs, and importers are correctly registered and SRNs are active.

2. Clean and Align UDI Data

UDI-DI data must align with:

• Technical documentation
• Certificates
• Labels and IFUs

3. Integrate EUDAMED Into PMS Processes

Post-market reporting workflows must include EUDAMED submission readiness.

4. Train Internal Teams

Regulatory, quality, and vigilance teams must understand:

• Module-specific responsibilities
• Submission triggers
• Data governance requirements

How Maven Regulatory Solutions Supports EUDAMED Compliance

Maven Regulatory Solutions provides end-to-end EUDAMED readiness and implementation support, including:

• Actor registration and SRN management
• UDI/Device registration strategy and execution
• Certificate and Notified Body data alignment
• PMS and vigilance submission integration
• Gap assessments against MDR and IVDR EUDAMED obligations
• Ongoing regulatory intelligence monitoring

Our experts help manufacturers move from compliance uncertainty to structured, audit-ready execution.

Conclusion

The publication of Commission Decision (EU) 2025/2371 marks a turning point in EU medical device regulation. With four EUDAMED modules now mandatory, manufacturers must transition from preparation to execution.

EUDAMED is no longer optional, it is a core regulatory infrastructure underpinning MDR and IVDR compliance. Companies that act early will reduce regulatory risk, improve data quality, and ensure uninterrupted EU market access.

FAQs: EUDAMED Decision 2025/2371

1. Which EUDAMED modules are mandatory under Decision 2025/2371?

Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance.

2. When does mandatory use begin for new devices?

28 May 2026 for MDR and IVDR compliant devices placed on the market after that date.

3. Do legacy devices need to be registered?

Yes. Legacy devices must be registered in the UDI/DEV module by 27 November 2026.

4. Is Actor Registration required for all manufacturers?

Yes. All economic operators must be registered in the Actor Module by 28 May 2026.

5. Can PMS submissions be made without EUDAMED registration?

No. Devices must be registered in EUDAMED before PMS or vigilance submissions once the module is mandatory.