This guide is for medical device and IVD manufacturers, authorized representatives, importers, notified bodies, and regulatory and compliance teams that need to understand when EUDAMED requirements become mandatory. It is particularly useful for organizations managing devices already on the EU market, new MDR/IVDR devices, legacy devices, or certificates issued before EUDAMED became mandatory.
This guide focuses specifically on the EUDAMED implementation timeline, including voluntary-use milestones, the 28 May 2026 mandatory-use date, device-registration transition periods, certificate-registration deadlines, and the expected rollout of the remaining EUDAMED modules.
It does not cover EUDAMED data requirements, UDI assignment or labelling, Basic UDI-DI rules, submission methods, machine-to-machine integration, or the detailed requirements of individual EUDAMED modules.
Introduction
After years of delays and voluntary use, EUDAMED entered a major new phase on 28 May 2026, when the first four modules became mandatory.
The milestone followed the publication of Commission Decision (EU) 2025/2371 in the Official Journal of the European Union on 27 November 2025. That decision formally declared the first four EUDAMED modules functional and triggered the six-month period leading to mandatory use.
As of 28 May 2026, mandatory use applies to the following modules:
- Actor Registration
- UDI/Device Registration
- Notified Bodies & Certificates
- Market Surveillance
The remaining Post-Market Surveillance and Vigilance and Clinical Investigations & Performance Studies modules are following separate implementation timelines and are not yet mandatory.
For manufacturers, understanding the timeline requires looking beyond 28 May 2026. Devices already placed on the market before mandatory use can have registration deadlines extending to 28 November 2026, while certain certificates have a transition period extending into May 2027.
EUDAMED Voluntary Use Timeline
EUDAMED was designed as six interconnected modules, but implementation did not occur all at once.
The Actor Registration module became available for voluntary use in December 2020. This allowed economic operators to register and obtain their Actor ID or Single Registration Number (SRN).
The UDI/Device Registration and Notified Bodies & Certificates modules followed in October 2021, allowing manufacturers and notified bodies to begin entering information voluntarily.
For several years, these modules remained voluntary while development and assessment of EUDAMED continued.
The regulatory approach changed with Regulation (EU) 2024/1860, which introduced the gradual rollout of EUDAMED. Instead of waiting until all six modules were fully functional, individual modules could become mandatory once they had been declared functional.
That change created the pathway to mandatory EUDAMED use.
Key Takeaway
EUDAMED moved from a voluntary system to a gradual mandatory rollout in which individual modules can become mandatory without waiting for the entire database to be completed.
EUDAMED Mandatory Use Timeline
27 November 2025: First Four Modules Declared Functional
On 27 November 2025, the European Commission published the notice declaring the first four EUDAMED modules functional in the Official Journal of the European Union.
The publication triggered a six-month transition period before mandatory use.
The four modules were:
- Actor Registration
- UDI/Device Registration
- Notified Bodies & Certificates
- Market Surveillance
28 May 2026: Mandatory Use Begins
The six-month period ended on 28 May 2026, making use of all four modules mandatory.
For manufacturers, the UDI/Device milestone is particularly significant. Manufacturers must now register applicable MDR and IVDR device information in EUDAMED in accordance with the mandatory-use and transitional rules.
Economic operators subject to the actor-registration requirements must also use the Actor module. Actor registration is important because registration in that module enables subsequent activities in EUDAMED and, where applicable, results in an Actor ID/SRN.
The Notified Bodies & Certificates module simultaneously became mandatory for notified bodies, while the Market Surveillance module became mandatory for competent authorities and the European Commission.
Key Takeaway
28 May 2026 was the major turning point in EUDAMED implementation: the first four modules moved from voluntary availability to mandatory use.
Device Registration Transition Timeline
The 28 May 2026 date does not mean that every device already on the EU market had to be retrospectively registered by that same day.
The transition rules distinguish between devices first placed on the market from 28 May 2026 onward and certain devices that had already been placed on the market before mandatory use.
Devices First Placed on the Market From 28 May 2026
For applicable MDR and IVDR devices first placed on the market from 28 May 2026, the device must be registered in the UDI/Device module before it is placed on the market.
This makes EUDAMED registration part of the normal market-entry timeline for newly introduced devices.
Devices Already on the Market Before 28 May 2026
Different rules apply where a Regulation device or applicable legacy device was first placed on the market before mandatory use of the UDI/Device module.
If additional units of the device are placed on the market from 28 May 2026, registration may be completed during a six-month transitional period.
The key deadline is 28 November 2026.
By that date, applicable devices benefiting from this transitional provision must be registered in the UDI/Device module.
This creates an important distinction:
- New applicable devices entering the market from 28 May 2026 generally require registration before being placed on the market.
- Certain devices already placed on the market before 28 May 2026 can have until 28 November 2026 to complete their EUDAMED registration where the transitional provisions apply.
Key Takeaway
28 November 2026 is a critical secondary EUDAMED deadline for applicable devices first placed on the market before mandatory use and for which additional units continue to be placed on the market.
Certificate Registration Transition Timeline
Certificates follow a different transition schedule from device registrations.
The Notified Bodies & Certificates module became mandatory on 28 May 2026. From that date, applicable new MDR and IVDR certificates issued by notified bodies must be registered in EUDAMED.
However, certificates issued before mandatory use are subject to a longer transition period.
28 May 2027: Certificate Transition Deadline
Applicable MDR and IVDR certificates issued before 28 May 2026 must be registered in EUDAMED by 28 May 2027.
This creates a 12-month period after mandatory use begins for the registration of applicable historical certificates.
The certificate timeline therefore differs from the device-registration timeline:
| Registration Type | Key Transition Deadline |
|---|---|
| Applicable devices already on the market | 28 November 2026 |
| Applicable MDR/IVDR certificates issued before mandatory use | 28 May 2027 |
Manufacturers should be aware of this difference because device and certificate information are interconnected in EUDAMED. Certain information referenced by notified bodies, including manufacturers and Basic UDI-DIs, needs to be registered before related certificate information can be entered.
Key Takeaway
Device and certificate transitions do not end at the same time. The major device transition deadline is 28 November 2026, while applicable historical certificates have until 28 May 2027.
Remaining EUDAMED Modules Timeline
Mandatory EUDAMED implementation did not end on 28 May 2026.
Two modules remain outside the first mandatory group:
- Post-Market Surveillance and Vigilance
- Clinical Investigations & Performance Studies
Post-Market Surveillance and Vigilance
The Post-Market Surveillance and Vigilance module remains under development.
The European Commission’s current roadmap anticipates publication of the notice declaring the Vigilance module functional in Q4 2026, subject to the outcome of the module’s audit.
If that occurs as planned, a six-month period would follow before mandatory use, with the Commission roadmap currently targeting Q2 2027.
These dates should be treated differently from the already-established 28 May 2026 deadline. The Commission specifically notes that the Vigilance timeline may be updated depending on the audit results.
Clinical Investigations & Performance Studies
The Clinical Investigations & Performance Studies module is also not yet mandatory.
The module remains under analysis and development, and the European Commission has not established a fixed mandatory-use date.
Importantly, the Commission states that the remaining two modules will be released when they become mandatory. Unlike the earlier modules, there will not be a period of voluntary use before mandatory use begins.
Manufacturers should therefore distinguish between confirmed deadlines and planned milestones when tracking the remaining EUDAMED rollout.
Key Takeaway
The Vigilance module is currently expected to become mandatory in Q2 2027, subject to audit and formal notice, while no fixed mandatory date has yet been established for Clinical Investigations & Performance Studies.
EUDAMED Timeline at a Glance
The major EUDAMED implementation milestones can be summarized as follows:
| Date | Major EUDAMED Milestone |
|---|---|
| December 2020 | Actor Registration module becomes available for voluntary use |
| October 2021 | UDI/Device and Notified Bodies & Certificates modules become available for voluntary use |
| 9 July 2024 | Regulation (EU) 2024/1860 published, establishing the gradual EUDAMED rollout framework |
| 27 November 2025 | Notice declaring the first four modules functional published in the OJEU |
| 28 May 2026 | Actor, UDI/Device, Notified Bodies & Certificates and Market Surveillance modules become mandatory |
| 28 November 2026 | Device-registration transition deadline for applicable devices benefiting from the six-month transition |
| Q4 2026* | Current target for publication of the notice declaring the Vigilance module functional |
| Q2 2027* | Current target for mandatory use of the Vigilance module |
| 28 May 2027 | Deadline for registration of applicable MDR/IVDR certificates issued before 28 May 2026 |
| TBD | Clinical Investigations & Performance Studies mandatory-use date |
*The Vigilance dates remain planned milestones and may change depending on audit results and publication of the required notice.
Which EUDAMED Date Applies?
For manufacturers, the timeline can be simplified into four questions:
- Is the device being introduced from 28 May 2026 onward? Determine whether it must be registered before being placed on the market.
- Was the device already placed on the market before 28 May 2026? Determine whether the transition period ending 28 November 2026 applies.
- Is an MDR or IVDR certificate involved? Certificates issued before mandatory use may fall within the separate transition period ending 28 May 2027.
- Does the activity involve Vigilance or Clinical Investigations/Performance Studies? These modules follow separate implementation schedules and should not be treated as part of the four modules that became mandatory on 28 May 2026.
Conclusion
The EUDAMED timeline has moved decisively from voluntary use to mandatory implementation.
The most important milestone was 28 May 2026, when the Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance modules became mandatory.
For manufacturers, however, two additional dates are particularly important: 28 November 2026, which marks the device-registration deadline for applicable devices benefiting from the transitional period, and 28 May 2027, which marks the registration deadline for applicable MDR and IVDR certificates issued before mandatory use.
The remaining EUDAMED modules are following their own implementation schedules. Vigilance is currently targeted for mandatory use in Q2 2027, subject to the required audit and formal notice, while a mandatory date for Clinical Investigations & Performance Studies has not yet been established.
The EUDAMED timeline should therefore be viewed as a gradual module-by-module rollout, with confirmed deadlines distinguished carefully from future dates that remain dependent on development, audit and formal publication.
