EUDAMED Modules and the 2026 Mandatory Use Timeline

1. Key takeaways

Under Article 33(2) of the MDR, EUDAMED consists of six interconnected modules and a public website. Commission Decision (EU) 2025/2371 (adopted 2025-11-26, published 2025-11-27) declared four modules functional: economic operator registration (Article 30), the UDI database and device registration (Articles 28 and 29), notified bodies and certificates (Article 57), and market surveillance (Article 100). Under Regulation (EU) 2024/1860, that publication triggers a 6-month transitional period, and these four modules become mandatory from 2026-05-28. The remaining two modules — vigilance and post-market surveillance, and clinical investigations and performance studies — are still under development and, per the European Commission’s official overview page, will be released at their mandatory use date with no voluntary period before it. The staged roll-out mechanism itself dates from 2024: Regulation (EU) 2024/1860 rewrote the old one-shot activation rule so the Commission can validate and announce each electronic system separately. Companies should manage EUDAMED readiness per module, with a status board that records the legal basis, voluntary availability and mandatory use dates for each system, and a switch-over plan for the two modules that will arrive without a trial window.

2. Legal basis

The module structure, the functional declaration and the staged roll-out rest on the following instruments.

3. Expert insights

Insight one: the six modules arrive in two batches, and the second batch has no voluntary trial window.

The six modules are: economic operator registration, UDI / device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and post-market surveillance, and market surveillance. According to the European Commission’s official overview page, the first four modules have been available voluntarily since December 2020 (Actor) and October 2021 (UDI / device registration and notified bodies and certificates) respectively; the last two modules (vigilance and post-market surveillance, and clinical investigations and performance studies) are still under development and will be released at their mandatory use date, with no voluntary use period before it. This statement is the central correction many published summaries need, because Chinese-language and other secondary sources often claim that all six EUDAMED modules are already online. Planning assumptions should be corrected accordingly: the first four can be used and tested now, the last two cannot.

Insight two: the staged roll-out mechanism is a 2024 change.

Regulation (EU) 2024/1860 (adopted 2024-06-13, in force 2024-07-09) changed EUDAMED from activation in one step after full functionality to a gradual roll-out: the Commission validates each electronic system as functional and publishes an announcement, and the related obligations apply from 6 months after that announcement. Article 34(2) was rewritten accordingly. This change is the precondition that allowed Decision (EU) 2025/2371 to declare four modules functional individually. Companies that built their compliance calendars on the old all-or-nothing activation model should re-baseline them on the announcement-plus-six-months rhythm, module by module.

Insight three: Article 78(14) ties the coordinated procedure for clinical investigations to the last module.

Under the amended Article 78(14): five years after the date of publication of the announcement referred to in Article 34(3) concerning the electronic system of Article 33(2)(e), namely the system for clinical investigations and performance studies, all Member States must apply the coordinated procedure; before that date, and after six months from the publication of that announcement, it applies only in Member States that agree to apply it. This means the launch of the clinical investigations module triggers a transition arrangement that runs for as long as five years, and sponsors should check the adoption status of the coordinated procedure in each target Member State when planning multi-country study submissions.

Insight four: once the market surveillance module (Article 100) becomes mandatory, the visibility of non-compliance records rises.

After the market surveillance module enters mandatory use, the exchange of market surveillance information between Member States runs through that electronic system. For companies, this means inspection outcomes in one Member State become more readily visible to others, and cross-market consistency of compliance becomes more important. A finding resolved locally can no longer be assumed to remain local, so corrective action quality and record completeness take on cross-border significance.

4. Practical recommendations

1. Maintain a per-module roll-out status board: module name, legal basis, voluntary availability date, mandatory use date, and relevance to your company.
2. Make the actions for the first four modules (Actor registration, UDI / device registration) mandatory checkpoints before release.
3. Prepare a switch-on-arrival plan for the last two modules, since there is no voluntary period available for trial and error.
4. For clinical investigation projects, confirm in advance the status of the Article 78(14) coordinated procedure in the target Member States.
5. Check the European Commission’s official EUDAMED overview page periodically for roll-out status, and do not rely on older screenshots.

5. Verification checklist

Use the following items to confirm that your EUDAMED readiness planning reflects the actual roll-out.

• □ A roll-out status board has been established for the six modules
• □ The mandatory use date of the first four modules (2026-05-28) is embedded in the processes
• □ Actor registration and UDI / device registration are complete and documented
• □ A switch-on-arrival plan is prepared for the last two modules
• □ Clinical investigation projects have confirmed the applicability status of Article 78(14)
• □ The staged mechanism of (EU) 2024/1860 and the 6-month transitional period rule are documented

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers in tracking the EUDAMED roll-out under the EU MDR, with EU Authorised Representative (AR) and PRRC services, registration support for the actor and UDI / device modules ahead of the 2026-05-28 mandatory date, readiness planning for the vigilance and clinical investigation modules, and fee and budget planning for notified body conformity assessment. Our team maintains per-module status boards and switch-over plans so that companies without an establishment in the European Union stay aligned with Regulation (EU) 2017/745 and Regulation (EU) 2024/1860. For practical support with registration, roll-out planning and budget matters, contact GRZAN at info@grzanglobal.com.