June 30, 2021

UDI Platform Release 2.5 is available

The UDI world keeps turning and our customers have to deal with different topics in the field of medical devices. This requires a UDI Platform that is able to handle these different demands, in order to register relevant medical devices in multiple countries.

Therefore we proudly announce the release 2.5 to improve daily work and to ensure continuous worldwide compliance.

The latest release brings some important features and updates, especially the Content Package for South Korea. With this, it is now possible to submit UDI-data to the South Korean regulatory database IMDIS. This includes both, data governance and Machine-2-Machine data exchange with the authority database, leveraging our Common Device Data (CDM) concept to re-use UDI-data that is already in place from existing authorities/databases. The M2M interface includes the new concept of periodic synchronization of Product Registration Data in IMDIS with the UDI Platform.

In addition, release 2.5 offers our customers an enhanced Mass upload as well as download capabilities. Now, approved data can be specified, if it shall be part of the Mass upload Excel templates or not. On the one hand, this helps to update certain attributes while still seeing the complete UDI data set, and on the other hand, in combination with our Page Designer, it provides a flexible way of exporting data from the UDI Platform.

Furthermore, companies with lots of devices are now able to upload up to 1,000 devices via the Mass upload at a time to save time and costs.

For Power Users we added a new application to visualize and inspect the various UDI data models. It allows to visualize data models from different authorities and compare with the Common Device Model and also identify custom changes / additions within each data model.

Have a look at all new features that have been updated on the latest version within the UDI Platform here:

  • South Korea MFDS IMDIS Content Package including M2M-communication available
  • Excel Mass Download / Upload app wizard
  • Mass Upload limit increase: Up to 1,000 devices can be uploaded at the same time
  • User Experience improvements
    • Search in Drop Down lists
    • Improved readability of PDF exports
    • Enable “Go to my Inbox” link
  • Dynamic attributes (MFDS)
    • Periodic synchronization of Product Registration Data with UDI Platform
  • Visualize Data Model
    • New app for Power Users to visualize UDI data models and inspect the relationship between the single models
  • Data models
    • Update to most current versions of EC EUDAMED data model definitions
    • Initial implementation of MFDS IMDIS data model

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