EUDAMED: The first four modules will be mandatory from May 28, 2026

The European Commission has officially confirmed that the first four EUDAMED modules will be mandatory from May 28, 2026 .

This decision marks a turning point in the full implementation of the European traceability and transparency system for health products under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR).

EUDAMED: The first four modules will be mandatory from May 28, 2026

What exactly happened?

On 26 November 2025, the Commission adopted the Decision declaring that certain EUDAMED modules meet the functional specifications required by the regulations.

Following its publication in the Official Journal of the European Union on 27 November 2025, a six-month transition period was automatically activated.

Result :

From May 28, 2026 , the use of the following modules will no longer be voluntary and will become mandatory.

The four modules that will be mandatory

Actor Registration

Includes:

• Manufacturers

• Authorized Representatives

• Importers

• Producers of systems/procedures

Without a valid registration (SRN), you cannot operate in accordance with MDR/IVDR.

UDI/Device Registration

It requires:

• Register each device in EUDAMED

• Enter basic UDI-DI information

• Keep data up to date

This module strengthens traceability and public transparency.

Notified and Certified Bodies

Includes:

• Publication of issued certificates

• Suspensions or withdrawals

• Public information regarding the certificate status

This increases market control and visibility for authorities and competitors.

Market Surveillance

It allows authorities to:

• Share information

• Coordinate corrective actions

• Manage monitoring measures

Although this module directly impacts authorities, economic operators may be affected by greater regulatory coordination.

Legal basis

The obligation is based on:

• Regulation (EU) 2024/1860 (transitional amendments)

• MDR (2017/745)

• IVDR (2017/746)

The formal activation of the obligation could only occur after the official declaration of functionality by the Commission, which has now happened.

What does this mean for manufacturers?

As of May 28, 2026:

• Alternative national registries will not be enough.

• EUDAMED will be the only valid platform for:

  • Operator registration

  • Device registration

  • Certificate Management

Non-European manufacturers must ensure that:

• Your Authorized Representative is properly registered

• Your SRN is active

• Your devices are loaded into the UDI module

• The information should be consistent with the technical documentation.

Strategic Impact

Beyond the legal obligation, this implies:

• Greater public transparency

• Greater traceability between Member States

• Greater exposure of certifications and regulatory status

• Higher probability of detecting document inconsistencies

For many companies that have postponed full registration, 2026 will be the true operational entry point into EUDAMED.

Conclusion

The mandatory implementation of the first four EUDAMED modules represents the definitive step towards the full digitalization and centralization of the European regulatory system for medical devices.

May 28, 2026 is not just an administrative date: it is the moment when European traceability becomes fully operational.