In September we informed you about our upcoming release of the UDI Platform.

We are pleased to announce that our latest release 2.6 of the UDI Platform is now available! As usual, we would like to give you detailed information about the new features as well as an overview of the improvements compared to the last version 2.5.

One major innovation is the Product Data Cockpit (PDC), which we would like to describe in detail below. The Product Data Cockpit is a new application within the UDI Platform, supporting you in getting insights you need at the right time. What does this mean exactly?

The PDC builds the foundation for effective process automation. In a first version we provide a smart overview for you of all your devices and device groups including their current governance and publication status information for each regulatory authority. Users can define multiple textual and visual filters to narrow down the results to show what’s really of interest. Stay tuned – within the next releases, we will enhance the PDC app to be deeply connected to the UDI processing, from insight to action!

Another major achievement is the availability of the content package for China for UDI data governance and submission to the CUDID database. As always, you will benefit from our Common Data Model (CDM), which allows you to reuse existing data (Common Device Data) and thus save time and budget to maintain UDI data for the NMPA. The content package for China NMPA (CUDID) includes the initial implementation of the data model, validation rules, workflows and UI pages based on the official NMPA guidelines as well as the Machine-2-Machnine submission interface to the NMPA CUDID database.

In addition to those major new features, we would like to give you an insight into the other improvements of the UDI Platform as well. Please see below the list of our further improvements within the current release:

Content Package EU I EC (EUDAMED)

  • Maintenance of a Basic UDI-DI request can be performed without assigning UDI-DIs. The assignment of a UDI-DI to a Basic UDI-DI was shifted to the UDI / Device level. The selection of the corresponding Basic UDI-DI can be selected directly when starting an EU UDI request

  • Update data model, validation rules, UI pages and submission templates based on latest version of EU data model (V7.1)

Mass Upload

  • Option to explicitly delete device characteristics via the Mass Upload function

  • UDI-DI to Basic UDI-DI assignment possible via Mass Upload

  • Enhanced validation rules and correct status handling

Data Elements Explorer

  • Graphical visualization of each authority data model and comparison of data fields of different UDI data models

UI improvements

  • Display essential field properties e.g. field formatting, allowed min. and/or max. field length, in field explanations

  • Rendering of selected values of multi-select fields e.g. Production Identifier was enhanced to display all values in read-only mode

  • Additional filter for reporting app to display devices in submission

  • Show available use cases / use case versions in Validation Rules App, the latest use case is highlighted

  • Page Designer allows to define data elements in UI page as read-only

Technical improvements

  • Upgrade UI5 version from 1.80 to 1.91

  • Functionality to perform mass uploads, mass downloads and mass submissions moved from administrator role to a new role called “Bulk Processor”

  • Implementation of “Cancel Workflow” operation during maintenance step

  • Remove of the claim function in SAP Inbox App

Keeping your UDI work simple – this is still one of our main goals and again had a huge impact on this release.

With our improvements and new features, we are getting closer to our UDI Platform vision “Derivation – Automation – Intelligence!” in order to be more and more able to deliver a UDI governance solution that is automated as far as possible to increase your efficiency and ensure your global UDI compliance.

You need additional information or have any questions? We welcome you to contact us.

Release Notes UDI Platform 2.6

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