The decision of 27 November 2025 changes the framework
Since its launch, EUDAMED operated on a principle of voluntary use for as long as the European Commission had not formally declared each module operational. On 26 November 2025, the Commission published Decision (EU) 2025/2371, which certifies that four modules are operational and comply with the functional specifications of MDR 2017/745. This decision stems from Regulation (EU) 2024/1860, which provides for a gradual roll-out of the modules, each becoming mandatory after individual audit and validation, without waiting for the whole system to be finalised.
From 28 May 2026, six months after the publication of this decision, the use of the four modules becomes mandatory. The era of voluntary registration is over for these scopes.
What is mandatory on 28 May 2026
The four modules concerned are: the Actors module (registration of economic operators), the UDI/Devices module (registration of devices and their identifiers), the Notified bodies and certificates module, and the Market surveillance module.
Actors module
All manufacturers, authorised representatives, importers and persons assembling systems or procedure packs must be registered in the Actors module no later than 28 May 2026. This obligation applies to new operators, but also to those who had registered with national competent authorities outside EUDAMED. Obtaining the SRN remains the precondition for using all the other modules.
UDI/Devices module
For new devices placed on the market after 28 May 2026, registration is mandatory before the first placing on the market. For devices already marketed before that date, a six-month transitional period is provided: registration must be completed no later than 27 November 2026.
Note for manufacturers who carried out national registrations in France: devices registered with the ANSM will have to be re-registered in EUDAMED’s UDI/Devices module before 28 November 2026.
Notified bodies and certificates module
This module falls mainly to the notified bodies. MDR/IVDR certificates issued before 28 May 2026 will have to be uploaded to the Certificates module no later than 28 May 2027, i.e. within 18 months. Manufacturers have no direct control over this registration, but have an interest in checking that their certificates have indeed been uploaded by their notified body.
Market surveillance module
This module is reserved for competent authorities. Manufacturers do not act directly, but it shapes the overall framework of post-market surveillance.
What is not yet mandatory: Vigilance and Clinical investigations
The Vigilance and Clinical investigations modules remain outside the mandatory scope. Until they are declared functional by the Commission, national obligations continue to apply.
For vigilance in France, the operational channel remains the ANSM. Under Article 92 of the MDR, manufacturers will have to use EUDAMED for their reports once the Vigilance module is declared mandatory. In the meantime, notifications must be submitted according to the national arrangements in force.
The audit of the Vigilance module is scheduled for the second quarter of 2026, with possible publication in the fourth quarter of 2026, subject to a satisfactory outcome. The obligation to use it would then come into effect around six months later, i.e. towards the first half of 2027.
Summary of the deadlines
| Deadline | Obligation |
|---|---|
| 28 May 2026 | Mandatory registration in the Actors module (SRN) |
| 28 May 2026 | Mandatory registration of any new device before placing on the market |
| 27 November 2026 | Deadline for registering devices already on the market (legacy) |
| 28 May 2027 | Deadline for uploading certificates issued before 28 May 2026 by the notified bodies |
| ~H1 2027 (provisional) | Vigilance module mandatory, if the Q2 2026 audit is conclusive |
What this means in practice
Registration in EUDAMED now conditions access to the European market for any medical device. A manufacturer not registered in the Actors module cannot register its devices. A device not registered in the UDI/Devices module cannot be placed on the market after 28 May 2026.
The concrete risks of poor preparation include the inability to register devices and therefore to place them on the market, inconsistencies between EUDAMED data and labelling — sources of non-conformity during audits — and a UDI traceability gap that complicates recalls or vigilance investigations.
For manufacturers not established in the European Union, the EC REP authorised representative registered under MDR Article 11 bears its own obligation to register in the Actors module. Consistency between the manufacturer’s and the representative’s registrations conditions the integrity of the file in EUDAMED.
Sources
- Commission Decision (EU) 2025/2371, published in the OJEU on 27 November 2025
- ANSM EUDAMED FAQ, updated February 2026