For manufacturers continuing to place medical devices and in vitro diagnostic devices on the EU market, November 28, 2026, marks an important EUDAMED registration deadline. Affected portfolios should be reviewed now to identify outstanding registrations, resolve data inconsistencies and confirm responsibilities.
RQMIS recommends targeting November 27 for completion. However, successful registration requires more than uploading information. It depends on reliable device data, clear ownership and a quality management system (QMS) that keeps regulatory records aligned as products change.
What Changed in 2026?
Following publication of Commission Decision (EU) 2025/2371 on November 27, 2025, four modules of the European Database on Medical Devices became mandatory on May 28, 2026:
- Actor Registration: Registration of applicable manufacturers, authorized representatives, importers and system/procedure pack producers.
- UDI/Device Registration: Submission of device identification and associated regulatory information.
- Notified Bodies and Certificates: Registration of applicable certificate information and notified body activities.
- Market Surveillance: Support for regulatory authorities’ market surveillance activities.
The remaining modules—Vigilance and Post-Market Surveillance and Clinical Investigations and Performance Studies—will follow their applicable implementation timelines. The Commission indicates that neither will have a voluntary-use phase before mandatory use.
Which Devices Fall Within the November Deadline?
The November transition generally covers qualifying MDR, IVDR and legacy devices first placed on the market before May 28, 2026, where additional units continue to be placed on the market on or after that date.
This does not mean every device previously sold in the EU must automatically be registered by November. Applicability depends on the device’s regulatory status and continued placement on the market. Certain legacy devices may also qualify for an exception where the same device is already registered under MDR or IVDR.
Manufacturers should distinguish between placing a device on the market and subsequent distribution of units already placed on the market. Documenting that assessment helps establish a defensible registration scope.
The Dates That Matter
Requirement
Mandatory use of the first four modules
Registration of qualifying MDR/IVDR devices first placed on the market on or after May 28, 2026
Registration of qualifying existing MDR/IVDR and legacy devices
Entry of applicable MDR/IVDR certificates issues before mandatory use
Applicable Date
May 28, 2026
Before the placement on the market
November 28, 2026
May 28, 2027
Key Qualification
Obligations depend on the actor, device, and activity involved
Applies to devices subject to UDI/Device registration
Generally applies where additional units continue to be placed on the market on or after May 28, 2026
Notified bodies are responsible; interviewing updates or decisions can require earlier entry
Planning recommendation: Complete applicable device registrations by November 27, allowing a practical margin before the official deadline.
Why EUDAMED Readiness Belongs in Your QMS
EUDAMED information should remain consistent with the applicable technical documentation, labeling, certificates and EU Declaration of Conformity. Registration is therefore an ongoing controlled activity.
Key areas to review include:
- Device identification: Verify Basic UDI-DI relationships in applicable regulatory documentation and UDI-DI information against labeling and device records.
- Legacy device records: Confirm regulatory status, applicable identifiers and relationships to MDR/IVDR versions.
- Certificate alignment: Check that device information accurately reflects applicable certificate scope.
- Change control: Assess whether product, labeling or regulatory changes require an EUDAMED update.
- Accountability: Assign responsibility for preparing, reviewing, submitting and maintaining records.
What Are the Risks?
Missing required registrations can create regulatory compliance and market-access risks. Inconsistent records may also lead to audit findings, corrective actions or questions from authorities and notified bodies.
Publicly accessible information can be reviewed by customers, distributors and other stakeholders, making accuracy important beyond an audit.
Manufacturers should also prepare for future reporting dependencies. Certain devices outside routine registration requirements may need registration before an applicable EUDAMED vigilance or post-market surveillance submission. Until the relevant module becomes mandatory, existing reporting obligations and applicable national processes continue.
What to Do Before the November Deadline
- Confirm that applicable actor registrations are complete and actor information is accurate.
- Identify devices requiring registration and document the rationale for exclusions.
- Reconcile device identifiers, classifications and certificate information against controlled records.
- Assign a named EUDAMED data owner and appropriate review responsibilities.
- Incorporate an EUDAMED impact assessment into change control.
- Coordinate certificate questions with your notified body.
- Verify completed registrations, resolve rejected records and retain review evidence.
- Assess future vigilance reporting dependencies.
How RQMIS Can Help
RQMIS helps manufacturers assess applicable EUDAMED requirements, reconcile device information and incorporate registration maintenance into their QMS. Our team can support portfolio reviews, clarify responsibilities and strengthen change control and registration records.
Contact RQMIS to discuss your EUDAMED readiness and prioritize remaining actions before the November deadline.