EUDAMED is mandatory—but 28 November is not a universal deadline
Four EUDAMED modules became mandatory on 28 May 2026. The 28 November 2026 device-registration date applies to the Commission's transition scenario for legacy or Regulation devices first placed on the market before mandatory use when additional units continue afterward.
Turn an applicable EUDAMED deadline into a deliverable portfolio plan
Yarify can translate the approved device scope into prioritized data waves, validation controls, submission preparation, and record-level reconciliation. Regulatory applicability remains with your qualified team; the implementation does not have to remain a spreadsheet exercise.
What the engagement produces
- A scoped record population with owners, evidence, and exclusions
- Prioritized preparation and validation waves tied to the applicable date
- Submission-ready outputs with exceptions and outcomes reconciled
The key dates answer different questions
The functionality decision was published on 27 November 2025. The Commission explains that this triggered a six-month transition, after which the first four systems became mandatory on 28 May 2026.
The 28 November 2026 date is narrower. The official device infographic connects it to legacy and Regulation devices first placed on the market before mandatory use when additional units are placed afterward. It should drive an evidence-backed portfolio segment, not a blanket assumption about every old product record.
The 28 May 2027 certificate date belongs to a separate certificate-module transition shown in the combined infographic. Maintain different owners, evidence, and reconciliation for device and certificate backlogs.
The EUDAMED transition timeline
Use the date, affected population, required preparation, and legal or operational change together. A date without its scope is not an implementation requirement.
| Date | Event | Who is affected | What to prepare | What changed |
|---|---|---|---|---|
| 27 November 2025 | Decision (EU) 2025/2371 and the functionality notice for the first four electronic systems were published in the Official Journal. | Economic operators, notified bodies, competent authorities, and the Commission according to their module-specific roles. | Confirm Actor registration, identify the applicable module workflows, inventory device and certificate backlogs, and assign accountable owners. | The publication triggered the six-month transition to mandatory use. |
| 28 May 2026 | Mandatory use began for Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance. | Actors that perform obligations in those modules. Market Surveillance is operated by competent authorities and the Commission, not as a manufacturer submission channel. | Use the applicable live EUDAMED workflow and register a Regulation device before placing its first unit on the market on or after this date. | The four systems moved from voluntary use into their applicable mandatory operating phase. |
| 28 November 2026 | Device-registration transition deadline for the scenario shown in the Commission infographic: a legacy or Regulation device had a first unit placed on the market before 28 May 2026 and additional units are placed afterward. | Manufacturers with records in that specific continued-placement transition population; the date is not a universal deadline for every historic record. | Segment the portfolio by first-placement and continued-placement status, resolve data gaps, approve device records, submit, and reconcile accepted outcomes. | The six-month device-registration transition window closes for the applicable population. |
| 28 May 2027 | Separate certificate timeline context: the Commission infographic shows this deadline for registering MDR/IVDR certificates issued before mandatory use of the Notified Bodies & Certificates module. | Notified bodies and certificate-data stakeholders for the applicable pre-mandatory certificate population. | Maintain a distinct certificate inventory, owner, applicability assessment, and reconciliation plan rather than combining it with the device deadline. | This is a later certificate-module milestone, not an extension of the 28 November 2026 device-registration deadline. |
Four mandatory systems, four operating contexts
The Commission overview identifies the four mandatory systems. It does not mean that every actor performs every workflow.
| Mandatory module | Practical meaning | Primary owner | Portfolio action |
|---|---|---|---|
| Actor registration | Actor identities, roles, access, and applicable registration obligations must be managed in the mandatory system. | Economic operator and its Local Actor Administrator or equivalent accountable owner | Verify the correct Actor context before mapping or releasing device records. |
| UDI/Device registration | Applicable device records now follow the mandatory EUDAMED registration and transition rules. | Manufacturer or other applicable registering actor, with regulatory-data ownership | Segment the portfolio, build the correct identifier hierarchy, validate data, and reconcile registrations. |
| Notified Bodies & Certificates | Notified-body and certificate workflows use the mandatory module, with a separate transition timeline for applicable earlier certificates. | Notified body, with manufacturer certificate stakeholders monitoring dependencies | Track certificate references and status separately from the device-registration backlog. |
| Market Surveillance | The electronic system is mandatory for competent-authority and Commission market-surveillance activity. | Competent authorities and the European Commission | Do not misread the module milestone as a new manufacturer bulk-submission workflow. |
Do not project the first-four date onto unfinished modules
At this page's review date, the Commission lists Clinical Investigations/Performance Studies as under analysis and Vigilance/Post-Market Surveillance as in development. Re-check the official overview and later functionality decisions instead of assigning them the 28 May 2026 milestone.
Test scope record by record
A useful deadline register preserves the facts that justify its treatment. Product status alone is not enough.
| Portfolio population | Deadline treatment | Evidence to preserve |
|---|---|---|
| Regulation device whose first unit is placed on the market on or after 28 May 2026 | Register before placing the device on the market. | Approved first-placement date/status, applicable device route, and accepted registration outcome |
| Legacy or Regulation device first placed before 28 May 2026, with additional units placed after that date | Treat 28 November 2026 as the transition deadline shown by the official device infographic. | First-placement evidence, continued-placement status, portfolio key, approved record, and reconciliation result |
| Historic device with no clear evidence of continued placement, or another fact pattern | Do not assign the 28 November date automatically. Route the facts through the current official Q&A and qualified regulatory review. | Documented applicability decision, owner, source evidence, and next action |
| MDR/IVDR certificate issued before mandatory use of the certificate module | Track against the separate 28 May 2027 certificate milestone where applicable. | Certificate identity, issue timing, notified-body owner, applicability decision, and registered-state evidence |
The table is an implementation reading of the official infographics, not legal advice. Use the Commission Q&A and qualified regulatory review for edge cases.
Turn the deadline into controlled release waves
Prioritize by applicability certainty, continued-placement exposure, missing approved data, relationship complexity, and submission readiness—not by spreadsheet row order.
| Control point | Decision | Required deliverable |
|---|---|---|
| Now | Which portfolio records are actually in the 28 November population? | Evidence-backed segmentation register with owner and confidence status |
| Next release wave | Which blocking gaps prevent approval or valid submission? | Prioritized exception register linked to source systems and accountable reviewers |
| Before submission | Are the data, operation, method, and technical baseline approved? | Frozen release manifest, validation report, and approval evidence |
| After submission | Which records were accepted, rejected, or left unresolved? | Record-level response log, corrected backlog, and reconciled internal status |
What Yarify can implement
Portfolio inventory and segmentation, source-to-target mapping, completeness and conflict checks, controlled-value normalization, review worklists, XML preparation, technical validation, submission manifests, response capture, and accepted-state reconciliation.
What remains a regulatory decision
The manufacturer and qualified advisers determine device route, placement facts, transition applicability, identifier assignment, certificate applicability, and approval of regulatory data. Technical readiness and successful submission do not guarantee MDR or IVDR compliance.
Move from dates into delivery
This guide owns official dates and consequences. The related pages own requirements, one-time migration, recurring automation, and method selection.
UDI requirements
Inventory the data, relationships, evidence, and owners required before submission.
Open guide →Data migration
Convert a one-time portfolio backlog into governed, submission-ready records.
Open guide →UDI automation
Operationalize recurring preparation, validation, submission, and reconciliation.
Open guide →Manual vs XML vs M2M
Choose a proportionate submission method for portfolio size and change frequency.
Open guide →Return to the EUDAMED automation hub for the complete cluster.
EUDAMED deadline questions
When did EUDAMED become mandatory?
Mandatory use began on 28 May 2026 for four electronic systems: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance. The Clinical Investigations/Performance Studies and Vigilance/Post-Market Surveillance modules were not part of that first-four functionality decision.
Is 28 November 2026 the deadline for every device?
No. The Commission's device-transition infographic scopes that date to legacy and Regulation devices whose first unit was placed on the market before mandatory use and for which additional units are placed after mandatory use. A Regulation device first placed on the market on or after 28 May 2026 must be registered before placement on the market. Other facts require an applicability review using current official guidance.
What happened on 27 November 2025?
Commission Decision (EU) 2025/2371 and the related functionality notice for the first four electronic systems were published in the Official Journal. That publication triggered the six-month transition that ended with mandatory use on 28 May 2026.
Does the 28 May 2027 date extend the device deadline?
No. The Commission's combined infographic presents 28 May 2027 as a separate deadline for the applicable population of MDR/IVDR certificates issued before mandatory use of the Notified Bodies & Certificates module. It should be managed as a separate certificate workstream.
Which EUDAMED modules are still outside the first mandatory group?
At the review date, the Commission overview listed Clinical Investigations/Performance Studies as under analysis and Vigilance/Post-Market Surveillance as in development. Re-check the official overview because later functionality decisions will create their own transition timing.
Can Yarify decide whether a product falls under a transition rule?
No. Yarify can implement portfolio segmentation, surface missing or conflicting evidence, prepare approved records, automate technical validation, and reconcile submissions. The manufacturer and qualified regulatory advisers remain responsible for regulatory applicability and approval of the underlying facts.
Primary sources and review cadence
Last reviewed 9 September 2026. Next scheduled review: 1 October 2026, and within two business days of a Commission functionality notice, Q&A revision, or transition-guidance change. Re-check live official sources before making a regulatory or release decision.
European Commission — EUDAMED overview
Official status of the six modules and confirmation that Actor, UDI/Device, Notified Bodies & Certificates, and Market Surveillance became mandatory on 28 May 2026
Commission Decision (EU) 2025/2371
Official Journal decision on the functionality of the first four EUDAMED electronic systems, published on 27 November 2025
European Commission — Four modules mandatory from 28 May 2026
Commission announcement connecting publication of the functionality notice to the six-month transition period
European Commission — Combined transition-period infographic
Official visual timeline for device registration and certificate registration, including the scoped 28 November 2026 and 28 May 2027 dates
European Commission — Device-registration transition infographic
Official timeline for legacy and Regulation devices first placed on the market before mandatory use and additional units placed afterward
European Commission — EUDAMED mandatory-use questions and answers
Official Q&A for interpreting the transition rules and module-specific scenarios
European Commission — Getting ready for mandatory use
Official preparation hub for mandatory EUDAMED use, factsheets, infographics, and transition guidance