EUDAMED Update: Version 3.11.0 Playground

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EUDAMED Update: Version 3.11.0 Playground

On April 24, 2025, the European Commission released a new technical update for the EUDAMED test environment (Playground). Version v3.11.0 includes significant enhancements, particularly in the UDI/Devices module.

Key Updates in the UDI/Devices Module:

  • Mandatory Master UDI-DI: For certain types of contact lenses (standard soft lenses, rigid gas permeable (RGP) lenses, and custom-made variants), a Master UDI-DI is now automatically required.

  • Additional fields for substances: Manufacturers can now provide information related to CMR substances, endocrine disruptors, tissues/cells, and other relevant substances.

  • Field renaming: The former field “Quantity per package” has been renamed to “Maximum quantity per package” to avoid misunderstandings regarding packaging units.

  • Improved tooltips and update functions: Enhanced usability for editing Master UDI-DI records, including container status and substance data.

Additional Key Updates:

Vigilance Module

  • FSN Transparency: Uploaded PDF documents within final Field Safety Notices (FSN) are now made publicly available by default.

  • Terminology updates for legacy/custom-made devices:

    • “Registration/Register” replaces “Create/Creation”

    • “Device Identifier” replaces “NRD code/NRD identifier”

    • “Registered” replaces “Submitted” as the final status

    • “Unknown” option added for 15 mandatory fields (e.g. measuring function, reusability, sterility)

  • Harmonised user interface across all Vigilance reports, with improved tooltips and smart filtering

DTX Interface – New Services

The DTX (Data Transfer Exchange) interface now supports uploading and downloading complete dossiers related to FSCA, MIR, NCAR, MTR, PSUR, etc., including Master UDI-DI information.

Three new service types:

  • Download service for existing dossiers

  • Upload service for new dossiers

  • Update service for modifying existing dossiers

Extended support for updating substance and tissue/cell data via DTX is now available.

Public API – New Transparency

The newly introduced Public API allows public and machine-readable access to selected device data such as:

  • Substances

  • Tissues and cells

  • Maximum quantity per package

Historical versions of Master UDI-DI records are also available.
Accessible modules include Actors, Devices, and Certificates.

Actors Module

  • Improved access control: Importers and non-EU manufacturers can now view all updates in their relationship links.

Market Surveillance

  • Extended country selection: When manually entering manufacturers or system pack producers, all available countries can now be selected.

Bug Fixes

This version resolves more than 30 reported bugs, including:

  • Access issues for various actor types

  • DTX validation errors and data duplication

  • Certificate management problems

  • Improvements in vigilance reporting workflows

  • Corrections to public website displays

Known Limitations

  • Email notifications are disabled in the Playground environment (notifications available via the bell icon in the dashboard)

  • Multilingual support is currently limited: labels are only partially available in languages other than English (restricted to Actors and UDI/Devices modules)

  • Several known issues will be resolved in future releases

Important Notes

  • This release applies exclusively to the Playground test environment. The production environment will be updated in the coming months.

  • Validation and error messages in the DTX interface will be further improved in future versions.

👉 Release Notes 

For any questions about EUDAMED or support in using the platform, our experts are happy to assist you.

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