On November 27, 2025, Commission Decision (EU) 2025/2371 was published in the Official Journal of the European Union, formally confirming that four EUDAMED modules had achieved full functionality under EU MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). That publication triggered a six-month transition period; which ended on May 28, 2026.
EUDAMED mandatory use is no longer approaching. It is here. From May 28, 2026, the four validated modules are compulsory for all relevant economic operators placing devices on the EU market. The shift from voluntary to mandatory is complete, and for manufacturers, authorized representatives, importers, system/procedure-pack producers, notified bodies, and sponsors, compliance is now an active legal obligation; not a future preparation exercise.
For organizations still in the process of completing Actor Registration, UDI/Device submission, or certificate uploads, the situation is urgent. Non-compliance creates direct commercial barriers: devices cannot be legally placed on the EU market without prior EUDAMED registration from May 28, 2026 onward.
What the Commission Decision Confirms
Commission Decision (EU) 2025/2371 formally confirmed that four EUDAMED electronic systems achieved full functionality and met the technical and functional specifications required under MDR/IVDR. This validation: drawn up under Article 34 of MDR in cooperation with the MDCG, triggered a legally binding six-month transition period that concluded on May 28, 2026.
EUDAMED is no longer “almost ready” or “voluntary.” These four modules have been audited, approved, declared compliant, and their mandatory use period has now begun. The practical consequence is straightforward: economic operators that have not completed Actor Registration and device data submission are operating outside the legal framework for EU market access.
The Four EUDAMED Modules Now Fully Functional
The four modules now in mandatory use are:
1. Actor Registration (Articles 30 MDR / 27 IVDR): All economic operators: manufacturers, authorized representatives, importers, SPPP producers, and sponsors must hold a valid Single Registration Number (SRN) obtained through this module before placing any device on the EU market. Without a valid SRN, no downstream registration activity is possible.
2. UDI & Device Registration (Articles 28–29 MDR / 25–26 IVDR): From May 28, 2026, no regulated device can be placed on the EU market without first being registered in EUDAMED’s UDI/Device module. An important additional consequence: refused notified body applications are now visible to all other notified bodies through this module — making accurate, complete first-time submissions more important than ever, as prior refusals must be disclosed and are visible across the system.
3. Notified Bodies & Certificates (Article 57 MDR / 52 IVDR): Notified bodies must upload all certificate information from May 28, 2026. Certificates issued before the mandatory date must be fully uploaded by May 28, 2027. Critically, if a device is not registered in the UDI/Device module, the notified body cannot link a certificate to it — creating a direct dependency between device registration and certificate validity in EUDAMED.
4. Market Surveillance (Article 100 MDR / 95 IVDR): Competent authorities now have full access to market-wide device and actor data through this module, enabling coordinated enforcement, safety signal response, and corrective action management across all Member States. Manufacturers should treat their EUDAMED data accuracy as audit-ready; inconsistencies between technical documentation, labeling, and EUDAMED entries are a growing area of market surveillance scrutiny.
Transition Periods & Key Deadlines
The Commission Decision triggers defined transition periods under the amended EUDAMED rollout model.
Mandatory Use Started 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 starting 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 starting 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
With mandatory use now active, the practical implications have shifted from preparation to verification and remediation.
For manufacturers and economic operators who have completed registration: Verify that Actor Registration SRNs are valid, device data in the UDI/Device module is complete and accurate, and that data is consistent with technical documentation, labeling, and certificate information. EUDAMED data accuracy is now a market surveillance audit target; inconsistencies create compliance risk even for organizations that technically registered on time.
For manufacturers with legacy devices still on market: The November 27, 2026 deadline for registering legacy devices in the UDI/Device module is the next firm milestone. Organizations should immediately triage their legacy portfolio by product line, revenue impact, and certificate expiry date to prioritize registration sequencing. Large portfolios with complex UDI hierarchies should not underestimate the data preparation time required.
For manufacturers who have not yet completed registration: Non-compliance with the May 28, 2026 mandatory use requirement creates direct commercial barriers. New devices cannot legally be placed on the EU market without prior EUDAMED registration. Organizations in this situation should treat remediation as an emergency priority and engage their authorized representatives and notified bodies immediately.
Cross-functional coordination remains essential: Regulatory Affairs, Quality, IT, and Supply Chain teams must maintain alignment: device data, certificate status, UDI assignments, and actor registrations must be consistent across all systems. EUDAMED is not a one-time data entry exercise; it is an ongoing compliance infrastructure requiring active maintenance.
Remaining EUDAMED Modules Still Pending
Two major EUDAMED segments remain under development and are not yet subject to mandatory use:
Clinical Investigations & Performance Studies module: For recording clinical studies, performance data, and related regulatory submissions. Until this module is declared fully functional and a new Commission Decision is published triggering its transition period, clinical investigation submissions continue through national systems (including RZPRO in the Czech Republic and equivalent national channels in other Member States).
Vigilance & Post-Market Surveillance module: For incident reporting, field safety corrective actions, and ongoing post-market monitoring. Until this module is mandatory, national vigilance reporting systems remain the operative channel for serious incident reports and FSCAs. Manufacturers should not assume that current national vigilance reporting obligations are replaced by EUDAMED; they remain fully in force until a new Commission Decision is published for these modules.
No formal timeline for these two modules has been officially confirmed as of June 2026. Manufacturers should monitor EUDAMED and MDCG announcements for updates, as a new Commission Decision confirming their functionality will trigger another transition period.
How to Prepare for Full EUDAMED Compliance
With the May 28, 2026 deadline passed, the action framework shifts from preparation to verification, remediation, and legacy device registration:
Step 1: Verify Actor Registration status: Confirm all relevant economic operators in your supply chain hold valid SRNs. Non-EU manufacturers must ensure their authorized representative’s SRN is current and that the manufacturer-AR linking in EUDAMED is complete.
Step 2: Audit UDI/Device data completeness: Review all registered device entries for accuracy and consistency with labeling, technical documentation, and notified body certificates. Data inconsistencies in EUDAMED are an active market surveillance risk; not just an administrative issue.
Step 3: Triage legacy device portfolio: Map all devices placed on the market before May 28, 2026 that are still being sold. Prioritize registration sequencing for the November 27, 2026 deadline by revenue impact, portfolio complexity, and UDI-DI assignment status.
Step 4: Coordinate notified body certificate uploads: Confirm that your notified body has uploaded current certificates to EUDAMED’s NB/Certificates module. Verify that certificate information in EUDAMED matches what is in your technical documentation; discrepancies create audit exposure.
Step 5: Prepare for the Vigilance and Clinical Investigation modules: Begin reviewing your national vigilance reporting processes and clinical investigation submission workflows now; so that when these modules are declared functional and a new Commission Decision triggers their transition period, your organization is not starting from zero.
| 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
Commission Decision (EU) 2025/2371 was a landmark moment in EU medical device regulation. The four EUDAMED modules it validated: Actor Registration, UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance are now mandatory, operational, and actively used for regulatory oversight across the EU.
For manufacturers and economic operators, the compliance picture in June 2026 is clear: the May 28, 2026 deadline has passed, Actor Registration and new device registration are active legal requirements, and the next firm milestone, November 27, 2026 for legacy device registration, is five months away. Organizations that have completed the May obligations should now focus on legacy portfolio triage and EUDAMED data quality. Those that have not yet completed mandatory registration should treat remediation as an immediate priority.
EUDAMED is now the core regulatory operating system for EU medical device market access. It is not an optional add-on, a future project, or a pilot system. It is live, it is mandatory, and compliance determines whether your devices can legally be placed on the EU market.
Q&A
Q: Is EUDAMED registration now legally mandatory, and what happens if I haven’t completed it?
A: Yes, mandatory use of the four validated EUDAMED modules began on May 28, 2026, following Commission Decision (EU) 2025/2371 published November 27, 2025. From that date, all new devices must be registered in EUDAMED before being placed on the EU market, and all economic operators must hold a valid SRN from the Actor Registration module. Organizations that have not completed registration are operating outside the legal framework for EU market access; new devices cannot be legally placed on the market, and the situation creates direct commercial barriers. Immediate remediation through your authorized representative and notified body is required.
Q: Which four EUDAMED modules are now mandatory under MDR and IVDR?
A: The four modules declared fully functional by Commission Decision (EU) 2025/2371, now mandatory from May 28, 2026, are: Actor Registration (SRN/Actor ID for all economic operators); UDI & Device Registration (device and UDI data for all devices placed on the EU market); Notified Bodies & Certificates (certificate information submitted by notified bodies); and Market Surveillance (competent authority access to device and actor data for enforcement and safety monitoring). The Vigilance/PMS and Clinical Investigations modules are not yet mandatory — national systems remain operative for those areas.
Q: Who must be registered in EUDAMED and by when?
A: All economic operators: manufacturers, authorized representatives, importers, system/procedure-pack producers (SPPP), and sponsors must be registered in the Actor Registration module and hold a valid SRN. This was required by May 28, 2026. Non-EU manufacturers must additionally ensure their authorized representative’s SRN is valid and that the manufacturer-AR organizational link is completed in EUDAMED before device registration can proceed.
Q: What is the deadline for legacy devices in the UDI/Device module?
A: Devices placed on the EU market before May 28, 2026 that are continuing to be sold must be registered in EUDAMED’s UDI/Device module by November 27, 2026. This is the next active compliance deadline for most manufacturers. Organizations with large legacy portfolios should triage by revenue impact and UDI-DI assignment status and begin registration immediately: data preparation, UDI hierarchy validation, and upload time should not be underestimated. Notified bodies must complete upload of certificates issued before mandatory use date by May 28, 2027.
Q: What are the consequences of inaccurate or incomplete EUDAMED data, even if registration was completed on time?
A: EUDAMED data accuracy is an active compliance obligation, not just a registration formality. All EUDAMED data must match across technical documentation, labeling, instructions for use, and certificates issued by the notified body. Inconsistencies can delay or block certification, trigger market surveillance actions, or flag compliance issues during competent authority reviews. Additionally, refused notified body applications are now visible to all other notified bodies in EUDAMED; making data quality and submission accuracy a competitive and reputational consideration, not just a regulatory one. Manufacturers should treat EUDAMED as live, audit-ready regulatory infrastructure requiring ongoing maintenance.
