We are constantly developing our UDI Platform to support our customer´s global UDI journey.

Now we released the latest version 2.4, bringing some great new features that support the daily work with UDI Compliance processes.

  • The enhancement of the custom data model extensions allows our customers the enhancement to specific value lists / vocabulary. This feature helps tailoring the UDI processes even more to our customer’s needs.

  • Based on the requirements of the European Commission we enabled our solution to support the maintenance of localized / language specific data for complex data elements like Critical Warnings and Contraindications. This feature is available for both, User Interface and Excel Mass Upload.

  • Parallel execution of workflow steps is now supported. Distribute your workflow tasks over your departments / business areas and allow for working on the data governance in parallel.

  • The UDI Area API now supports the triggering of workflows from external systems to further automate your UDI processes and to enable a tighter integration into your process landscape. In addition, the API supports setting a manual submission status for devices and device groups to reflect current specifications of the EUDAMED database for MDR risk classes IIa, IIb, III, respectively classes B, C and D for IVDR.

  • To support ongoing tests with the European Commission for EUDAMED M2M data exchange, the mass submission app was extended to allow for the submission of Basic UDI-DIs together with its associated devices / UDI-DIs.

  • We implemented the latest EUDAMED data model version 6 into our solution and also the most current data model of the MFDS UDI database (South Korea).

Find all new features that have been updated on the latest version within the UDI Platform here:

  • UDI Area API for triggering workflows, setting manual submission status

  • Enhancement of Audit Trail to capture save events

  • Introduction of Mass Submission app for EUDAMED M2M

  • Parallel workflow task execution

  • Support for custom data element value / vocabulary lists

  • Maintenance of localized data within complex data elements

  • Data derivation engine enhancement to automatically add submission status of a device in all markets (Regulatory Authority Variants)

  • Data models

    • Update to most current versions of EC EUDAMED data model definition

    • Initial implementation of MFDS UDI data model

Stay tuned for more information regarding our latest version of the UDI Platform or contact us.

Release_Note_UDI_Platform_2.4

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