On November 27, 2025, the Commission Decision (EU) 2025/2371 was published in the Official Journal of the European Union (OJEU), marking a major milestone in the implementation of the European Database on Medical Devices (EUDAMED) under the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR).
This development matters for manufacturers, authorized representatives (ARs), importers, system/procedure-pack producers (SPPP), notified bodies (NBs), and sponsors. The validation of these modules triggers transition periods and accelerates the full rollout of EUDAMED, meaning that regulatory, quality, supply-chain and IT teams must now get ready.
At a high level, this milestone shifts EUDAMED from a “voluntary or optional” status to a core compliance infrastructure which unlocks full transparency, traceability and harmonized regulatory data flows across the EU.
What the Commission Decision Confirms
The Commission Decision (EU) 2025/2371 confirms that four electronic systems/modules of EUDAMED have achieved full functionality and meet the technical and functional specifications required under MDR/IVDR.
This formal validation aligns with the functional specifications that were drawn up under Article 34 of MDR (in cooperation with the Medical Device Coordination Group (MDCG) and marks the start of a legally binding transition period.
EUDAMED is no longer “almost ready.” These four modules have been audited, approved, and declared compliant.
The countdown to mandatory use has officially begun.
The Four EUDAMED Modules Now Fully Functional
Each of the four validated modules plays a distinct role under MDR/IVDR. Below we outline their purpose and which stakeholders must engage with them:
1. Actor Registration: Articles 30 MDR / 27 IVDR
This module allows economic operators (manufacturers, authorized representatives, importers, SPPP producers, and other relevant actors) to obtain a unique Actor ID / Single Registration Number (SRN). Through submission of an actor registration request, they register their entity in EUDAMED, creating a harmonized, EU-wide identifier. All economic operators must obtain their Actor ID/SRN before the deadline, ensuring that every player in the device supply chain is identifiable in EUDAMED.
2. UDI & Device Registration: Articles 28–29 MDR / 25–26 IVDR
This module handles registration of medical devices (or IVDs) by linking each device to its Unique Device Identifier (UDI), thus providing clear device traceability and public transparency through the EU-wide UDI/Device database. Manufacturers (and SPPP producers) must register each device placed on the EU market, enabling traceability, transparency, and compliance with UDI obligations under MDR and IVDR.
From the mandatory date onward, no regulated device can be placed on the EU market without first being registered in EUDAMED.
3. Notified Bodies & Certificates: Article 57 MDR / 52 IVDR
This module records information about notified bodies and the certificates of conformity they issue (including amendments, suspensions, withdrawals, refusals, and restrictions). Having this module fully functional means that conformity assessment and certification data will be centrally tracked facilitating regulatory oversight, ensuring validity of device certificates, and supporting transparent audits. Notified bodies must enter all relevant certificate data into EUDAMED going forward. This centralization supports harmonized tracking of device conformity across the EU.
4. Market Surveillance: Article 100 MDR / 95 IVDR
This module enables competent authorities to monitor and surveil medical devices on the market; it supports enforcement, compliance checks, and safety-issue tracking across Member States. By completing this module, regulators can more effectively coordinate market surveillance, respond to safety signals, and manage corrective actions, which enhances patient safety and transparency throughout device lifecycles. Regulators now have full access to market-wide device and actor data, helping to ensure that devices on the EU market meet MDR/IVDR requirements and remain traceable.
Transition Periods & Key Deadlines
The Commission Decision triggers defined transition periods under the amended EUDAMED rollout model.
Mandatory Use Starts May 28, 2026
As of May 28, 2026 (six months after publication) use of the four validated modules became compulsory for all relevant economic operators.
Economic Operator Registration Deadline
By May 28, 2026, all manufacturers, authorized representatives, importers, system/procedure-pack producers (SPPP), and sponsors must be registered (Actor Registration) in EUDAMED.
UDI & Device Registration Timelines
- Devices placed on the market from May 28, 2026 must be registered in the UDI/Device module before first placement.
- Legacy devices (i.e., devices already on the market before the mandatory date) with an assigned UDI-DI have until November 27, 2026 to be entered into EUDAMED’s UDI/Product module (unless an equivalent regulated device is already registered).
Certificate Upload by Notified Bodies
Notified Bodies must begin uploading certificate information and updates as of May 28, 2026; for certificates issued prior to mandatory use, full upload obligations apply by May 28, 2027 (18 months after publication).
Overall, this means the industry now has a clear, non-negotiable timeline. Organizations must treat EUDAMED readiness as a top priority and begin real work now.
What This Means for Manufacturers & Other Stakeholders
This shift has practical implications across regulatory, quality, supply-chain, and IT functions.
- Increased administrative load & planning needs: Organizations must plan for registration of actors, devices, certificates, and ensure data completeness and accuracy.
- Focus on data accuracy and system readiness: Because EUDAMED becomes the central repository, poor or inconsistent data will likely result in compliance issues, delayed market access, or enforcement actions.
- Cross-functional coordination across teams: Regulatory Affairs, Quality, IT and Supply-Chain teams must collaborate, ensuring UDI assignment, device registration, certificate management, and internal processes are aligned.
- Risk of commercial barriers for non-compliant operators: As noted by experts, incomplete UDI strategy or missing actor registration may result not just in administrative failure, but actual commercial roadblocks devices may not be accepted for market placement.
Therefore, organizations should treat EUDAMED as core market-access infrastructure regarding compliance.
Remaining EUDAMED Modules Still Pending
While the first four modules are now fully functional, two major segments of EUDAMED remain under development:
- Clinical Investigations & Performance Studies module: For recording clinical studies, performance data, and related regulatory submissions.
- Vigilance & Post-Market Surveillance (PMS) / Vigilance module: Intended for incident reporting, field safety corrective actions, and ongoing post-market monitoring.
These modules still need to be validated, after which a new decision will be published, likely triggering another transition period leading to full EUDAMED mandatory use.
For now, some aspects of post-market data and clinical/performance-study reporting may still rely on national systems or legacy processes. True end-to-end lifecycle tracking will only come once all modules are live.
How to Prepare for Full EUDAMED Compliance
To ensure smooth compliance with the coming deadlines, organizations should take concrete steps now:
1. Assess data readiness
- Review existing device portfolios (new, legacy, custom-made)
- Identify missing UDI-DI assignments or incomplete product series data
2. Update internal processes
- Define workflows for actor registration, device registration, certificate submission
- Assign clear responsibilities (Regulatory Affairs, Quality, IT, Supply-Chain)
3. Ensure cross-team alignment
- Regulatory + IT + Quality must coordinate to ensure proper data input
- For notified bodies: ensure capacity and processes to submit certificates in time
4. Plan for legacy device migration
- Map legacy devices on the market pre-May 28, 2026 and prepare for registration by November 27, 2026
- Confirm that UDI-DI codes are assigned and series/product definitions are clear
Organizations that begin preparing now will avoid last-minute rush, errors, and potential regulatory or market-access risks.
| Nov 27, 2025: Commission Decision 2025/2371 published → 6-month transition period |
| May 28, 2026: Mandatory use of Actor, UDI/Device, Notified Bodies & Certificates, Market Surveillance modules begin |
| Nov 27, 2026: Deadline for registration of legacy devices (UDI/Product module) |
| May 28, 2027: Deadline for upload of pre-existing certificates and Master SSP/SSCP by Notified Bodies |
The industry now has a clear compliance roadmap, every economic operator must align with EUDAMED in stages over 2026–2027.
Conclusion
The publication of Commission Decision (EU) 2025/2371 is a big moment for EU medical device regulation. By declaring four EUDAMED modules (Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance) fully functional, the EU has triggered the transition to mandatory use.
The countdown is on: May 28, 2026 is no longer a target, but a hard deadline.
For manufacturers, ARs, importers, SPPP producers, notified bodies, and sponsors, this means immediate action is required. Data readiness, internal workflows, cross-department coordination, and timely registrations are now critical.
Now is the time to treat EUDAMED as your core regulatory operating system, not an optional add-on. Act early, coordinate across units, and ensure compliance before the deadline.
The countdown has officially begun. Failure to comply will likely impact market access, regulatory conformity, and ability to place devices on the EU market.
Q&A
When do manufacturers need to comply with the new EUDAMED deadlines?
Manufacturers (and other economic operators) must comply by May 28, 2026 when the four validated EUDAMED modules become mandatory. Legacy devices must be fully registered by November 27, 2026.
Which EUDAMED modules are now fully functional under MDR and IVDR?
The fully functional modules are: Actor Registration; UDI & Device Registration; Notified Bodies & Certificates; Market Surveillance.
Who must register in EUDAMED by May 28, 2026?
Manufacturers, authorised representatives, importers, system/procedure-pack producers, and sponsors, essentially all economic operators involved in placing devices on the EU market.
What are the deadlines for legacy devices in the UDI/Product module?
Legacy devices placed on the market before May 28, 2026 must be entered into the UDI/Product module by November 27, 2026.
