Which EUDAMED dates matter now?
The first four modules became mandatory on . The notice of functionality was published in the Official Journal on . Those milestones are confirmed by the European Commission’s EUDAMED overview and Commission Decision (EU) 2025/2371.
The legacy device registration deadline is . The Commission’s devices and certificates timeline confirms that deadline and for qualifying earlier MDR/IVDR certificates. These dates concern different records and different responsibilities. Neither is a general extension of the conditions for lawful market placement.
What is the source for the legacy device registration deadline?
The Commission’s devices and certificates timeline gives as the deadline to register the relevant devices in the UDI/Device module. It shows the transition for legacy or Regulation devices whose first unit was placed on the market before mandatory use and whose additional units continue to be placed on the market afterward.
The Decision confirms module functionality and its publication date. The transition provisions are in Regulation (EU) 2024/1860, amending the MDR and IVDR. Ask a qualified professional to confirm how those provisions apply to your portfolio. Plan completion early enough to allow correction and review.
What changed when mandatory use began?
Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance became mandatory on . That does not mean every manufacturer must personally use every module. Market Surveillance is for competent authorities and the Commission, while notified bodies have their own certificate-record responsibilities.
For a manufacturer, separate the actor identity question from the device-data question. An approved manufacturer actor record does not demonstrate that every relevant device has been entered. A device record does not, by itself, establish that a certificate is valid or that every applicable regulatory condition has been satisfied. Your review should connect these records without treating any single search result as the whole compliance position.
The remaining Vigilance and Clinical Investigation/Performance Studies modules have separate implementation work. Check the Commission’s current overview rather than extrapolating dates from the first four modules. This guide does not assign an unverified mandatory-use date to either remaining module.
Does the November transition apply to every older product?
No. Determine the device’s regulatory route, when the first unit was placed on the market, and whether further units continue to be placed on the market after mandatory use began. An older catalog entry alone does not answer those questions. The Commission’s transition materials distinguish legacy devices from Regulation devices, and include relevant portfolios in both categories.
“Legacy device” has a regulatory meaning in the transition from the earlier Directives to the MDR or IVDR. It is not simply another name for everything sold before May. In a mixed portfolio, different models can have different routes and evidence. Keep the status assessment separate from the date of a spreadsheet export, the age of a product family, or the date an importer first ordered stock.
Create a working inventory that records the legal manufacturer, intended EU market route, identifiers, first-placement evidence, continued-placement plans, and current EUDAMED status. This is a practical planning recommendation, not a prescribed Commission template. Where the evidence is unclear, mark the question for professional review instead of declaring the device exempt or overdue.
What about devices first placed on the market after mandatory use?
For Regulation devices first placed on the market after mandatory use began, registration generally belongs before market placement. Do not use the later transition date as an automatic grace period for a newly introduced device. Confirm category-specific exclusions and special cases with the current rules and a qualified adviser.
The Commission’s gradual-rollout Q&A explains the practical transition. A team introducing a new model should therefore include registration in the release plan, rather than attaching it to a separate November cleanup exercise. This avoids mixing ongoing launch controls with the backfill of qualifying existing records.
What should you do first if the SRN is missing?
Confirm the legal actor and its registration status first. The Single Registration Number identifies an economic operator; it is not the identifier for a product. Read the SRN registration guide before commissioning a device upload against an uncertain entity.
A useful sequence is actor registration and access, then identifier mapping, then device records, then reconciliation. For Regulation devices, the identifier mapping includes the Basic UDI-DI structure and the specific UDI-DIs. For legacy devices, check the appropriate legacy identifier route instead of forcing every product into the Regulation-device structure. Work on data preparation in parallel where practical, but do not confuse a prepared file with an accepted record.
Assign an owner to the actor question. Ask for the exact legal name, the SRN or request status, the concerned competent authority, and the person who can respond to corrections. An email saying that registration is “in progress” is a useful lead, but it is not completion evidence. Avoid opening duplicate requests merely because the approved record was searched under a different trading name.
How can you turn the portfolio into a manageable work queue?
Split the work by the decision that is blocking progress. A missing actor, an uncertain identifier group, incomplete device data, and a submission error need different owners. A single undifferentiated “EUDAMED incomplete” list makes it difficult to know which action will unlock the next record.
For each item, capture the record being checked, the available evidence, the next action, the owner, and the expected completion evidence. Preserve the distinction between not found in a public search, not yet submitted internally, and rejected or incomplete in an authorized account. Those states should not be collapsed into a public claim of non-compliance.
Prioritize the items with external dependencies, including competent-authority review, an AR mandate question, or a disputed grouping decision. This does not change the legal importance of the remaining records. It simply gives the team a clearer way to use limited preparation time and escalate questions before the deadline.
Which certificate records need attention by May 2027?
The transition in the Commission timeline concerns qualifying MDR/IVDR certificates issued before mandatory use of the Notified Bodies & Certificates module. New certificates after mandatory use have a different registration timing. Do not read the later date as permission to postpone all certificate work.
Coordinate with the notified body responsible for the certificate. Ask which certificate records are in scope, which device groups they cover, and how the manufacturer should verify the public record and report discrepancies. Keep certificate validity, transition eligibility, and database entry as related but separate review questions. This site neither uploads certificates nor determines whether a particular certificate permits continued market access.
What should you ask an external provider to deliver?
Request an agreed scope and evidence of what was checked, prepared, submitted, and accepted. A provider can describe which actor and devices are covered, what depends on your team, and how errors will be corrected. Avoid a scope defined only as “EUDAMED registration” without a portfolio boundary.
Ask who maintains the record after the initial entry. Product changes, new models, corrected attributes, and changes of business relationships can create future work. A successful initial upload should be handed over with the source data, responsible contacts, and a way to reconcile subsequent updates. No transmission method removes the need for accountable data ownership.
Can a free public-record check settle the question?
A free check can provide a useful starting point: what could be found, under which name or identifier, on which date. It cannot establish a complete regulatory position. Public visibility, search choices, and the supplied company identity can all affect the observation.
Request a free registration check for a short findings note, or tell us your situation if you need an introduction to an independent EU specialist. EUDAMED Compliance provides information and referrals. A qualified professional must review decisions about your specific devices, and any specialist engagement is agreed directly with that provider.