The end of May 2026 carries two distinct regulatory deadlines for IVD manufacturers operating in the EU, and they apply to different devices, different obligations, and different consequences if missed. One is about market access for legacy Class C devices. The other is about EUDAMED registration becoming a legal requirement for everyone.
If your team is only tracking one of these, this post is worth reading before the month is out.
Under Regulation (EU) 2024/1860, manufacturers of legacy Class C IVDs that were self-declared under the old In Vitro Diagnostic Directive (IVDD) must lodge a formal application for conformity assessment with an EU Notified Body by May 26, 2026. Missing this date means losing eligibility for the extended IVDR transition period entirely.
What "legacy Class C" means here. A legacy IVD is a device that was placed on the EU market with a valid IVDD certificate before May 26, 2022. Under IVDR (EU) 2017/746, many devices previously self-certified under IVDD now fall into Class C and require Notified Body involvement for the first time. That reclassification is what makes this deadline so consequential for teams that have not had to engage a Notified Body before.
What the extended transition actually offers. Class C legacy devices that meet the transition conditions can remain on the EU market until December 31, 2028. But that runway is conditional. To qualify, manufacturers must have met the following milestones:
By May 26, 2025: an IVDR-compliant Quality Management System in place
By May 26, 2026: formal application lodged with a Notified Body
By September 26, 2026: signed written agreement with that Notified Body
By December 31, 2028: full IVDR-compliant certification complete
If the May 26, 2026 application deadline is missed, the extended transition provisions no longer apply. The practical consequence is that a device may need to be pulled from the EU market until a full IVDR certificate is granted, a process that currently takes 18 to 24 months on average.
A common point of confusion worth addressing. The May 26 deadline is for lodging the application, not for completing conformity assessment. A full Notified Body review of the application is not required before the written agreement is signed. However, Notified Bodies are already working through a high volume of applications, and incomplete or low-quality submissions create back-and-forth that eats into timelines. Submitting now with a complete package is significantly lower risk than submitting at the last moment.
Two days after the Class C application deadline, EUDAMED becomes a legal obligation for all IVD manufacturers placing devices on the EU market under IVDR.
On November 27, 2025, the European Commission published Commission Decision (EU) 2025/2371, formally confirming that four EUDAMED modules are now fully functional. That publication triggered a six-month transition period under Regulation (EU) 2024/1860, landing the mandatory use date on May 28, 2026.
The four modules moving from voluntary to mandatory are:
Actor Registration — the gateway to all other EUDAMED functions
UDI/Device Registration — required before any new device is placed on the EU market
Notified Bodies and Certificates — centralized certificate management under MDR and IVDR
Market Surveillance — used by Competent Authorities, tied to your device data
Who this applies to. Any manufacturer, EU Authorized Representative, or importer operating under IVDR (EU) 2017/746. Non-EU manufacturers must register through their EU Authorized Representative, whose Competent Authority then validates the registration and issues the Single Registration Number (SRN). Without a valid SRN, device registration cannot proceed.
The two device registration timelines. New IVDs placed on the EU market on or after May 28, 2026 must be registered in EUDAMED before placement. There is no grace period for new devices. Legacy devices already on the EU market before May 28, 2026 have until November 28, 2026 to complete registration. That six-month window is a structured transition, not an invitation to delay. One important exception: if a legacy device becomes subject to a vigilance action, serious incident, or Field Safety Corrective Action before registration is complete, immediate registration is required regardless of the November deadline.
Actor registration is the bottleneck nobody planned for. Everything in EUDAMED depends on having an active SRN. Device registration, certificate linking, vigilance reporting — none of it is accessible without one. Teams that have not started Actor registration are at risk of cascading delays because validation by the Competent Authority is not instantaneous.
UDI data is inconsistent across documentation. EUDAMED requires that device data entered in the system matches technical documentation, labeling, and Instructions for Use exactly. For Class C and Class D IVDs, the Notified Body must confirm Basic UDI-DI data before registration is published. That step adds time that teams have frequently not accounted for.
Legacy device portfolios are underestimated. Large IVD portfolios with products certified under IVDD rather than IVDR require a separate legacy registration pathway. Teams that have not audited which products qualify as legacy devices and which have transitioned to IVDR are likely to underestimate the full scope of work.
Marketing claims need to align with EUDAMED entries. The public-facing EUDAMED database will display device data including intended purpose, warnings, and CMR substance declarations. Any mismatch between EUDAMED entries and promotional materials or labeling is a potential misbranding issue.
For Class C legacy IVD manufacturers:
If a Notified Body application has not been submitted, that is the only priority right now
Confirm your IVDR classification rationale before submitting — misclassified devices are a common reason applications stall
Ensure your QMS was IVDR-compliant as of May 26, 2025, as this is a prerequisite for transition eligibility
Plan for the September 26, 2026 written agreement deadline immediately after the application is submitted
For EUDAMED registration:
Complete Actor registration first and obtain your SRN before attempting anything else in EUDAMED
Audit your device portfolio to identify new devices, IVDR legacy devices, and IVDD legacy devices because each has a different pathway and timeline
Validate UDI data against technical documentation, labeling, and IFU before entering anything into EUDAMED
Confirm certificate upload timelines with your Notified Body, particularly for Class C and Class D devices requiring NB confirmation
Build EUDAMED data maintenance into your QMS procedures — under IVDR Article 28(3), manufacturers are responsible for ongoing accuracy of all data entered in the system
These two deadlines are close together but they are not the same obligation. Class C legacy manufacturers are navigating both simultaneously: an application to a Notified Body and mandatory EUDAMED registration within the same two-week window. Teams that have been treating these as separate workstreams in isolation from each other are likely carrying more risk than they realize.
If your team needs support working through either deadline, whether that is Class C Notified Body application preparation, EUDAMED registration, or IVDR QMS alignment, we are glad to help you get there.