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EUDAMED v3.11.0 - What medical device manufacturers should know

Medical devices regulation

On April 24, 2025, the European Commission released version v3.11.0 of the EUDAMED Playground. While this release doesn't shake everything up, it brings several relevant changes - and a few caveats - that manufacturers should be aware of. Here’s a detailed overview focused on the most relevant modules: UDI/Devices, Vigilance, CIPS and Market Surveillance.


UDI / Devices – More data on substances and packaging Key updates

  • Master UDI-DI registration is now triggered for several types of contact lenses.
  • New sections can be filled in: CMR, tissues and cells, substances.
  • Field renamed: “Quantity per package” becomes “Maximum quantity per package”.
  • These details can now be updated when creating a new Master UDI-DI version.


Known issues

  • No mechanism for managing multiple trade names per Master UDI-DI yet.
  • No technical fixes in this release.



Vigilance – Automatic publication and consistent wording Notable changes

  • PDFs attached to the Country Specific Details section of a final FSN are now made public by default.
  • Terminology cleanup for legacy/custom-made devices: “Register” replaces “Create”, and more.
  • “Unknown” option now available for many mandatory fields.


Fixes

  • Improved tooltips and smart filters across vigilance reports.
  • IVDR removed from applicable legislation for legacy devices.


Known issues

  • Cannot submit MIR if device is linked to a certificate.
  • Incorrect validation error for non-reportable MIRs.
  • Duplicate “Applicable legislation” field in MTRs, premature PSRP notifications, and more.




CIPS – Clinical investigations and language bugs

The CIPS module manages clinical investigations and performance studies. No new features or fixes this time, but one known issue remains: selecting several countries with no common language will cause a random language to be displayed in the national form.



Market Surveillance – Small but welcome fix Improvement

  • Free country selection now available when registering a Manufacturer or System Pack Producer in a procedure or FIR.


Limitation

  • Trigger link for SAE procedures still missing, pending CIPS integration.




Mini-FAQ

  • Do these changes apply to the production version?
    Not yet – this is only for the Playground environment.

  • Should I update my Master UDI-DI records?
    Only if you're affected or wish to enrich your data with new fields.

  • Should I be concerned about FSN auto-publication?
    Check with your quality/regulatory teams to adjust your internal process.




Need help?

At CSDmed, we support medical device manufacturers from classification strategy to EUDAMED registration. Let’s ensure your devices are accurately classified and fully compliant with the latest EMDN updates.


Authored by Guillaume for CSDmed

Consultant in R&D, quality and regulatory affairs for medical devices. Based in Monaco, I help manufacturers meet MDR, CE and FDA expectations - without derailing timelines or sanity.




EUDAMED user guide CI/PS for Sponsors EUDAMED user guide Legacy Devices registration EUDAMED user guide UDI Devices EUDAMED user guide Registration of Old/custom-made devices in the Vigilance module EUDAMED user guide Vigilance for EOs EUDAMED user guide Market Surveillance EUDAMED Release notes