Background and Scope of the Decision
On November 26, 2025, the European Commission published Decision 2025/2371 in the Official Journal of the European Union, certifying that four of the modules of the European database on medical devices (EUDAMED) are operational and comply with the functional specifications set forth in Regulation (EU) 2017/745 and Regulation (EU) 2017/746 for in vitro diagnostic devices.
The four systems in question are:
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The Economic Operators Registration Module (“Stakeholders”)
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The UDI database + the device registration module (“UDI/Devices”)
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The module on notified bodies and certificates (“Notified Bodies & Certificates”)
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The Market Surveillance Module
This functionality assessment follows an independent audit of the systems, dated June 18, 2025.
Immediate consequences: Start of the transition period
The publication of the decision in the Official Journal of the European Union (OJEU) marks the start of a six-month transition period, in accordance with the provisions of the MDR and IVDR, which sets May 28, 2026, as the effective date for the requirement to use the four modules.
As of that date, these modules will no longer be optional: registration in EUDAMED will become mandatory.
Key Deadlines and Obligations
Here is a summary of the requirements for the various modules:
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“Market Participants” Module: All relevant economic operators must be registered by May 28, 2026, and obtain an SRN (Single Registration Number), which is a prerequisite for using the other modules.
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“UDI/Devices” Module:
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For new devices (MDR/IVDR) placed on the market after May 28, 2026: registration is required before the device is first placed on the market.
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For devices already on the market prior to that date but intended to remain on the market: a 12-month transition period—registration must be completed no later than November 27, 2026.
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“Notified Bodies & Certificates” Module: Notified bodies must register certificates issued on or after May 28, 2026. For certificates issued prior to that date, an additional grace period applies—which extends the deadline to no later than May 2027.
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“Market Surveillance” Module: Competent authorities will be required to apply this module starting May 28, 2026. Even though manufacturers are not directly involved, this module influences the overall framework for post-market surveillance.
Status of the remaining modules (Vigilance, PMS, Clinical Investigations, etc.)
Decision 2025/2371 applies only to the four modules listed. The other modules—in particular, the “Vigilance / Post-Market Surveillance / Clinical Studies” module—have not yet been declared operational and are therefore not subject to any immediate requirement to use them.
Conclusion and Recommendations
EUDAMED has officially moved out of the development phase and into a phase of regulatory compliance. For manufacturers, importers, authorized representatives, and notified bodies, it is now essential to:
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Immediately set up the “Actors” (SRN) records;
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Organize and prepare UDI-DI data for the “UDI/Devices” module;
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Plan the integration of existing certificates into the “Notified Bodies & Certificates” module;
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Stay informed about the next steps for the “Vigilance / PMS / Clinical Investigations” modules.
