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 (ARs), Notified Bodies, importers, 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.

At Maven Regulatory Solutions, we support global medical device manufacturers with EUDAMED implementation, MDR and IVDR compliance strategy, UDI registration support, vigilance readiness, PMSV integration, and ongoing regulatory intelligence monitoring aligned with evolving European Commission expectations.

What Is EUDAMED?

EUDAMED (European Database on Medical Devices) is the European Commission’s centralized digital platform designed to support implementation of:

• Regulation (EU) 2017/745 (MDR)
• Regulation (EU) 2017/746 (IVDR)
• EU market surveillance activities
• Medical device traceability
• Vigilance and post-market surveillance reporting
• Public transparency of medical device information

EUDAMED serves as the backbone of the EU’s modernized medical device regulatory framework.

Why EUDAMED Was Released in Phases

When MDR and IVDR were first adopted, regulators initially intended to launch all six EUDAMED modules simultaneously. However, the technical complexity and scale of the database created significant development delays.

To address these challenges, Regulation (EU) 2024/1860 amended MDR and IVDR, allowing EUDAMED modules to become mandatory individually once independently audited and confirmed functional.

This phased implementation strategy enabled the European Commission to progressively activate modules while maintaining regulatory continuity.

Commission Decision (EU) 2025/2371 now formally triggers mandatory use of the first four EUDAMED modules.

Commission Decision (EU) 2025/2371: Overview

Commission Decision (EU) 2025/2371 was published on 27 November 2025 and represents the official legal confirmation that specific EUDAMED modules are operational and ready for mandatory use.

The decision consists of:

• Six recitals
• Two binding articles

One of the most important regulatory confirmations appears in Recital 4, which states that the independent audit verifying functionality was completed on 18 June 2025.

This audit confirmation is the legal trigger that allows the European Commission to impose mandatory use requirements under MDR and IVDR.

The Four EUDAMED Modules Now Mandatory

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

1. Actor Registration (ACT) Module

The Actor Registration Module requires mandatory registration of:

• Manufacturers
• Authorized Representatives
• Importers
• System and procedure pack producers
• Other economic operators

The module supports:

• Assignment of Single Registration Numbers (SRNs)
• Economic operator identification
• Access permissions for additional EUDAMED modules
• Regulatory traceability across the EU market

Actor registration forms the foundation for all subsequent EUDAMED activity.

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

The UDI/DEV module requires registration of:

• UDI-DI information
• Core device data
• Basic UDI-DI records
• Device classifications
• Market status information

This module supports:

• Enhanced traceability
• Device transparency
• Market surveillance oversight
• Alignment with global UDI systems
• Public access to selected device information

Manufacturers must ensure consistency between technical documentation, labels, certificates, and EUDAMED submissions.

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

The NB/CRF module manages:

• MDR and IVDR certificates
• Conformity assessment records
• Certificate validity tracking
• Notified Body oversight activities

The module improves:

• Regulatory transparency
• Oversight of conformity assessments
• Certificate traceability
• Public access to certificate status

It also creates direct linkage between certificates and registered devices.

4. Market Surveillance (MSU) Module

The Market Surveillance Module supports:

• Post-market surveillance submissions
• Vigilance reporting
• Periodic Safety Update Reports (PSURs)
• Manufacturer Incident Reports (MIRs)
• Field Safety Corrective Actions (FSCAs)
• Trend reporting activities

The module significantly strengthens Competent Authority oversight and centralized PMSV coordination across the EU.

Mandatory EUDAMED Deadlines Manufacturers Must Know

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

These deadlines establish the first fully enforceable EUDAMED obligations under MDR and IVDR.

Special Scenarios Manufacturers Must Consider Actor Registration Is Mandatory First

Regardless of device status, all economic operators must complete Actor Registration before using other EUDAMED modules.

Manufacturers of legacy devices must ensure:

• SRN assignment is complete
• Authorized Representative information is accurate
• Importer relationships are aligned
• Access permissions are validated

Failure to complete Actor Registration may prevent access to device registration and vigilance workflows.

PMS and Vigilance Submissions Require EUDAMED Readiness

If a device is:

• Subject to post-market surveillance activities
• Included in vigilance submissions
• Associated with PSURs, MIRs, FSCAs, or trend reports

Then the device must be properly registered in EUDAMED before submissions can be completed once the Vigilance and PMS modules become mandatory.

This directly links PMSV compliance obligations with EUDAMED readiness.

EUDAMED Module Obligations & Deadlines

Why This Decision Matters for MDR & IVDR Compliance

The publication of Decision 2025/2371 transforms EUDAMED from a voluntary preparation initiative into a mandatory regulatory infrastructure.

Manufacturers must know:

• Align internal regulatory systems with EUDAMED workflows
• Standardized device and UDI data
• Improve PMS and vigilance reporting readiness
• Strengthening cross-functional coordination between regulatory, quality, IT, and supply chain teams
• Ensure data consistency across technical documentation and EUDAMED submissions

Failure to comply may lead to:

• Regulatory nonconformities
• Delayed market access
• Increased Competent Authority scrutiny
• Post-market submission delays
• Audit observations
• Enforcement risks under MDR and IVDR

Strategic Preparation: How Manufacturers Should Prepare

1. Confirm Actor Registration Status

Manufacturers, ARs, and importers should ensure:

• SRNs are active
• Registration data is accurate
• Organizational information is up to date
• Access permissions are correctly assigned

2. Clean and Align UDI Data

UDI information should align with:

• Technical documentation
• Labels and IFUs
• Certificates
• Device master records
• Internal ERP and quality systems

3. Integrate EUDAMED Into PMS Processes

Organizations should revise procedures to support:

• Digital vigilance workflows
• Structured data submissions
• PMSV integration
• Trend reporting coordination
• EUDAMED-linked CAPA processes

4. Train Internal Teams

Regulatory, quality, vigilance, and IT teams must understand:

• Module-specific responsibilities
• Submission timelines
• Data governance requirements
• EUDAMED workflow structures
• Regulatory escalation procedures

5. Strengthen Manufacturer–AR Coordination

Close collaboration between manufacturers and Authorized Representatives is essential for:

• Accurate device registration
• Vigilance coordination
• PMS reporting alignment
• Submission consistency
• Regulatory communication management

Impact On Global Medical Device Manufacturers

Organizations marketing products across multiple EU jurisdictions may experience expanded compliance obligations.

Manufacturers with strong digital compliance infrastructure and mature PMS systems will be better positioned to adapt efficiently.

Future Trends in EUDAMED & EU Regulatory Oversight

The rollout of mandatory EUDAMED modules reflects broader modernization efforts across European medical device regulation.

Emerging trends include:

• Increased digital regulatory infrastructure
• Expanded UDI traceability
• Greater automation of vigilance workflows
• Structured XML submissions
• Enhanced Competent Authority Oversight
• Improved transparency across EU markets
• Stronger lifecycle monitoring of medical devices
• More harmonized reporting systems across Member States

The future EU regulatory landscape will become increasingly data-driven, interconnected, and technology-enabled.

Quick Facts

• Four EUDAMED modules are now officially mandatory under Decision 2025/2371
• Mandatory implementation begins on 28 May 2026 for new MDR and IVDR devices
• Legacy devices must be registered by 27 November 2026
• Actor Registration is required before using other modules
• PMS and vigilance submissions will depend on EUDAMED readiness
• UDI data consistency is critical for compliance
• Manufacturers should begin implementation planning immediately
• EUDAMED will become central to MDR and IVDR lifecycle compliance

Why This Matters

EUDAMED is no longer optional preparation infrastructure.

It is becoming the operational backbone of EU medical device regulation.

Organizations that fail to prepare effectively may face:

• Delays in EU market access
• Increased audit findings
• Regulatory enforcement actions
• Submission rejections
• Inconsistent device records
• Vigilance reporting disruptions
• Expanded Competent Authority scrutiny

Early implementation planning and strong internal coordination will be essential for maintaining uninterrupted MDR and IVDR compliance.

How Maven Regulatory Solutions Supports EUDAMED Compliance

Our Services

• Actor Registration and SRN support
• UDI/Device registration strategy
• EUDAMED implementation consulting
• PMSV integration support
• Vigilance workflow optimization
• MDR and IVDR SOP development
• Regulatory intelligence monitoring
• Gap assessments against EUDAMED obligations
• Authorized Representative coordination
• Audit readiness preparation

Why Choose Maven

• Deep expertise in MDR and IVDR compliance
• Strong EUDAMED implementation capabilities
• Practical regulatory strategy guidance
• Up-to-date regulatory intelligence monitoring
• End-to-end compliance support
• Experience supporting multinational manufacturers
• Cross-functional PMSV and vigilance expertise

Learn more at Maven Regulatory Solutions.

Need Support with EUDAMED Compliance?

Maven Regulatory Solutions helps medical device manufacturers navigate evolving MDR and IVDR EUDAMED obligations with confidence.

We Help You With

• Actor Registration and SRN management
• UDI and device registration
• PMSV workflow integration
• Vigilance readiness planning
• MDR and IVDR SOP development
• EUDAMED data alignment
• Regulatory intelligence monitoring
• Audit readiness preparation

Partner With Maven Regulatory Solutions To:

• Strengthen MDR and IVDR compliance
• Improve EUDAMED readiness
• Reduce regulatory risk
• Enhance vigilance reporting efficiency
• Streamline UDI registration processes
• Maintain uninterrupted EU market access

Contact Maven Regulatory Solutions today to strengthen your EUDAMED compliance strategy.

Conclusion

The publication of Commission Decision (EU) 2025/2371 marks a major turning point in EU medical device regulation.

With four EUDAMED modules now officially mandatory, manufacturers must transition from preparation to execution.

EUDAMED is rapidly becoming the central regulatory infrastructure underpinning MDR and IVDR compliance, vigilance reporting, market surveillance, and device traceability across the European Union.

Manufacturers should now focus on:

• Actor Registration Readiness
• UDI data alignment
• PMSV integration planning
• SOP modernization
• Cross-functional coordination
• Continuous regulatory intelligence monitoring

Organizations that act early and build adaptable compliance systems will be best positioned to reduce regulatory risk and maintain uninterrupted access to EU markets.

FAQs

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

Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance modules are now mandatory.

2. When does mandatory EUDAMED use begin?

Mandatory implementation begins on 28 May 2026 for new MDR- and IVDR-compliant devices.

3. Do legacy devices need to be registered in EUDAMED?

Yes. Legacy devices placed on the market before 28 May 2026 must be registered by 27 November 2026.

4. Is Actor Registration required for all manufacturers?

Yes. All economic operators must complete Actor Registration and obtain SRNs.

5. How does EUDAMED affect PMS and vigilance reporting?

PMS and vigilance submissions such as PSURs, MIRs, FSCAs, and trend reports will increasingly depend on EUDAMED registration and workflow integration.

6. What are the biggest EUDAMED compliance challenges?

Common challenges include UDI data alignment, system integration, SOP updates, cross-functional coordination, and digital reporting readiness.

7. How can Maven help with EUDAMED compliance?

Maven supports EUDAMED implementation, Actor Registration, UDI registration, PMSV integration, vigilance readiness, SOP development, and MDR/IVDR regulatory strategy.