EUDAMED registration guide for medical device manufacturers

What does EUDAMED registration mean for your device?

EUDAMED registration records your organisation and device information in the European database on medical devices. Four modules became mandatory on 28 May 2026, but the device registration deadline depends on your device's regulatory status and when units enter the EU market. It is not a single deadline for every product.

If your first unit was placed on the market before 28 May 2026 and you continue placing units of the same device identifier on the market from that date, the transition deadline is 28 November 2026. A Regulation device whose first unit enters the market on or after 28 May generally needs registration before that first placement. The distinction matters more than the age of your company or when you obtained a certificate.

This guide helps you turn those rules into a portfolio review, an evidence checklist and a registration work queue. It covers EU MDR and IVDR registration, not Swiss registration, conformity assessment or permission to keep selling a legacy device. Registration does not replace the applicable requirements for lawful market access.

The European Commission's EUDAMED overview confirms the mandatory modules and dates. Its gradual rollout Q&A, especially questions 7, 8 and 14, explains the boundaries behind the device deadlines. The Q&A is practical guidance, not a binding interpretation of the legislation.

Which EUDAMED modules are mandatory?

The Commission overview confirms that Actor registration, UDI/Device registration, Notified Bodies and Certificates, and Market Surveillance became mandatory on 28 May 2026. That does not mean your manufacturer account must submit information to all four. Your role determines what you do, and the remaining modules have their own rollout rather than inheriting this date.

The Commission overview currently lists Post-Market Surveillance and Vigilance and Clinical Investigations and Performance Studies as not yet mandatory. For vigilance, question 13 of the rollout Q&A says to continue using national processes until the Vigilance module becomes mandatory. An unfinished EUDAMED module does not suspend your underlying safety reporting obligations. Recheck the overview when planning a submission because module status can change.

The rollout follows Commission Decision (EU) 2025/2371 and the transition framework introduced by Regulation (EU) 2024/1860. Keep actor, device and certificate tasks separate in your plan. Completing one does not prove that the others are complete.

Which devices need registration by 28 November 2026?

The 28 November deadline applies to the transition cohort described by the Commission, including legacy and Regulation devices first placed on the EU market before 28 May 2026 where additional units of the same identifier are placed on the market on or after that date. Check exclusions and the same-device exception before assigning work.

The Commission's dated transition diagram shows both conditions. A product appearing in an old catalogue is not enough to establish either one. You need a defensible record of placement before the cutoff and whether placement continued afterwards.

Use this sequence for each device identifier rather than applying one answer to an entire product family. It applies questions 7 and 8 and the question 14 safety-reporting exception to a portfolio review.

1. Confirm the regulatory category. Separate MDR or IVDR Regulation devices from devices lawfully supplied under the relevant legacy transition provisions. Keep custom-made, investigational, performance-study and old devices out of the standard branch until you have assessed their specific treatment.
2. Establish the first placement. For a Regulation device first placed on the market on or after 28 May 2026, register before that first unit is placed on the market. The November transition window is not a general grace period for new launches.
3. Check continued placement. If the first unit was placed before 28 May and more units of the same identifier enter the market on or after that date, assess registration against 28 November 2026.
4. Assess the no-further-placement branch. Where no more units are placed on the market from 28 May, the Q&A does not require routine registration under this transition rule. Later post-market surveillance or vigilance actions can change the registration need.
5. Review legacy duplication. A legacy device may not need a separate record if the same device is already registered as a Regulation device. Record the basis for that conclusion and retain the vigilance exception described below.

Do not use a shipment date without establishing what that shipment represents. Placing on the market concerns the first making available of an individual device on the Union market. A later sale of a unit already placed on the market is not automatically a new placement. The MDR and IVDR definitions, your supply chain and the actual transaction evidence matter. The MDR and IVDR both define these terms in Article 2.

What changes for legacy devices and discontinued products?

Legacy status does not create a blanket exemption from EUDAMED device registration. Equally, stopping production does not by itself establish that no further units are being placed on the market. Review regulatory status, actual placement and remaining stock separately, then document the registration conclusion for each identifier.

When can a legacy device share the Regulation device's registration?

Question 8 of the Commission Q&A says a legacy device does not need registration if the same device is already registered as a Regulation device. It explains sameness through identification, such as UDI-DI, catalogue or reference number, or trade name, arising from shared characteristics. Changes that would lead to a new UDI-DI mean the devices are not the same for this purpose.

A similar product name is therefore not a sufficient shortcut. Compare the identifiers and characteristics, capture the already registered Regulation record, and have the regulatory owner confirm the conclusion. If a vigilance action specifically concerns the legacy device rather than the same Regulation device, question 14 describes an exception that can require a separate legacy registration for reporting in the Vigilance module.

Does a discontinued device need a record?

If no units are placed on the market from the mandatory-use date, questions 8 and 14 describe a route without routine UDI/Device registration unless the manufacturer must perform a relevant post-market surveillance or vigilance action in the EUDAMED Vigilance module. Until that module becomes mandatory, continue using the applicable national reporting processes. Keep the supporting evidence and a process for reopening the decision. A commercial decision to discontinue a product does not erase the manufacturer's responsibilities for devices already supplied.

Custom-made and old devices have different treatment. Question 8 of the Q&A says they cannot be registered in the UDI/Device module and describes a limited device dataset for relevant serious incident or field safety corrective action reports in the Vigilance module. Question 7 also excludes investigational devices and devices for performance studies from the ordinary UDI/Device registration branch. Do not force these categories into a standard upload template.

How do you turn the rules into a portfolio work queue?

Build one controlled row per device identifier and connect the deadline decision to evidence. The Q&A’s UDI/Device introduction explains that device registration is at identifier level rather than a separate entry for every serial number or batch. Your assessment still needs unit-level placement evidence where that determines which transition branch applies.

The following examples are illustrative, not customer cases or legal conclusions for your portfolio. They assume ordinary in-scope devices and lawful placement. Rows A to C apply question 7 and the dated transition diagram; rows D and E apply question 8 with question 14. The evidence column is our recommended working practice, not a prescribed legal form.

For your working sheet, add an accountable owner, next action, blocker, target completion date and reviewer to each row. Use separate statuses for data prepared, data checked, registration submitted and registration completed. A file ready to upload should not appear as a completed registration in a management report.

The practical benefit is visibility. A founder can see which product depends on actor validation, which needs a regulatory decision and which is ready for submission, without reading every source document. The worksheet is an operational aid, not an additional EUDAMED legal requirement.

What should you prepare before registering an actor?

Actor registration establishes the organisation and role that will perform actions in EUDAMED. A user's login is not the same as a validated actor registration. Check whether the correct legal entity and role already exist, then confirm that the people doing the work have the necessary access.

The Commission's actor registration guidance explains that the national competent authority assesses and approves the request before EUDAMED issues the Actor ID or Single Registration Number. It also requires a signed declaration on information security responsibilities. A non-EU manufacturer needs an active authorised representative and a mandate summary document with its request.

Before submission, reconcile the legal name, address, role and representative details with your controlled records. Agree who will handle questions from the authorised representative or competent authority and who can act if the primary contact is unavailable. These are recommended workflow controls, not promised processing times.

Questions 3 to 5 of the Commission Q&A distinguish actors that receive an SRN under the MDR or IVDR actor-registration provisions from other actors that receive an Actor ID. Distributors do not have a general EUDAMED actor-registration requirement simply because they distribute devices, although national registration requirements may apply. If the same business also acts as an importer or manufacturer, assess that role separately.

Which device data should you check before submission?

Start with the current EUDAMED data requirements for the device category, then map every required field to a controlled source. Do not start by copying the nearest product spreadsheet. A technically accepted submission can still contain an incorrect regulatory category, inconsistent identifier or outdated certificate reference.

Use the EUDAMED Information Centre for current user guides, technical documentation and business rules. The following is a preparation checklist rather than an exhaustive field specification.

• Reconcile the manufacturer and authorised representative details with the actor records.
• Confirm whether the record is a Regulation device, legacy device or another supported category.
• Check the relevant device identifiers and their relationships against the controlled identifier strategy. Do not treat a Basic UDI-DI, a UDI-DI and a production identifier as interchangeable.
• Confirm the device name, intended purpose, classification and applicable nomenclature against the technical documentation.
• Check certificate references and the relationship to the notified body's record where applicable.
• Identify which fields need updates when the device, certificate or actor details change.

For each field, record the source document or system, its version, the data owner and the person who checked it. If two sources disagree, resolve the discrepancy before submission rather than choosing whichever value passes validation. Test any bulk-upload process against the current technical specifications and retain the validation results with the final registration evidence.

Legacy devices follow their own identifier rules. The UDI/Device introduction and question 8, footnote 14 describe EUDAMED ID or UDI-DI at device-registration level for legacy devices and note that they are not subject to MDR or IVDR UDI requirements merely because they are legacy devices. Use the current legacy registration instructions rather than manufacturing an MDR-style identifier to satisfy an internal spreadsheet.

What should happen after submission?

Close the work item only when you have checked the completed registration and retained enough evidence to reproduce the decision. Record the submitted dataset, identifiers, outcome, date and any corrections. Then connect future updates to your existing change-control process so registration does not become an isolated annual clean-up.

Separate a completed device submission from public visibility. Question 7 of the Commission Q&A, note on public visibility notes that some device data become public only after the notified body enters the associated product certificate information. An absent public result is therefore a reason to investigate the record and dependency, not automatic proof that the manufacturer failed to submit.

Certificate backfill has a different timeline and owner from manufacturer device registration. Question 10 describes an 18-month period from the functionality notice for relevant pre-mandatory-use Regulation certificate records. Do not apply that certificate period to your device-registration deadline or assume that your upload completes the notified body's work.

A useful closeout review asks whether the correct actor owns the record, whether the registered data match the approved source, whether any dependent certificate action remains open and who will update the record next. Keep unresolved items visible until the responsible party closes them.

How should you prioritise work before the deadline?

Prioritise unresolved applicability decisions and external dependencies before routine data entry. If you discover a device first placed after 28 May without its required registration, do not simply put it into the November backlog. Escalate the actual facts promptly to the responsible regulatory lead and assess the appropriate corrective action.

For the transition cohort, use a short sequence that exposes blockers early.

1. Reconcile the portfolio and confirm the applicable branch for every identifier.
2. Clear actor-registration and user-access dependencies.
3. Resolve missing or conflicting source data and check the selected upload method.
4. Submit with time to correct rejected or incomplete records.
5. Verify completion, preserve evidence and assign ongoing maintenance.

Work backwards from your applicable deadline using actual internal capacity and the responses you need from other parties. There is no universal number of days for actor validation or a guaranteed registration lead time. An owner and a dated next action are more useful than an optimistic completion percentage.

How does registration fit your wider regulatory work?

Your EUDAMED record should agree with the regulatory strategy, technical documentation and quality processes you already maintain. It does not establish that a legacy device remains eligible for transition, replace conformity assessment or resolve a classification question. Resolve those decisions on their own evidence, then carry the result into registration.

If the underlying issue is ownership rather than an upload, explore how Envoy supports regulatory work. If you are deciding how to control the supporting records, the guide to choosing an eQMS explains the distinction between a quality system and the software that holds its documents.

Dovetail's approach starts with the regulatory decision and the evidence behind it. Bring the portfolio, the unresolved questions and the deadline to the conversation so the next step can address the real gap rather than add another disconnected checklist.

Sources and further reading

Evidence behind the registration decisions

• EUDAMED overview, European Commission. Check the current mandatory modules and published rollout dates before assigning deadlines.
• Q&A on practical aspects of the gradual rollout of EUDAMED, hosted by the European Commission. Questions 3 to 5 cover actor roles, 7 and 8 cover device registration and exceptions, 10 covers certificates, and 13 and 14 explain vigilance timing. This explanatory document is not a binding legal interpretation and states that it has not been formally endorsed by the Commission.
• Transition period for legacy and Regulation devices placed on the market before mandatory use, European Commission. Use the one-page diagram with question 7 to check the before-May and continued-placement conditions for 28 November 2026.

Practical help for preparing your submission

• Actor registration module guidance, European Commission. Follow the registration-request and user-access steps and use the linked information-security declaration and non-EU manufacturer mandate-summary templates.
• EUDAMED Information Centre, European Commission. Find the current module user guides and technical documentation linked from the actor guidance. Check the version relevant to your submission method rather than treating this article’s preparation checklist as a field specification.
• Choosing an eQMS for a medical device startup, Dovetail. Consider how to control the records supporting your registration decisions. This is workflow guidance, not a source of EUDAMED legal requirements.