March 09, 2021

Project Insights: Implementation of FDA GUDID Content Package including migration

In October 2019, we announced the start of our first EUDAMED project for UDI Platform with a world-leading medical device manufacturer. Meanwhile, the project has been finalized and our customer is ready to submit product master data to the EUDAMED database, in accordance with the specific validation rules and different data formats, as soon as the European Commission provides the necessary interface capabilities.

In order to enable our customer to submit UDI-related data to FDA GUDID using the UDI Platform, we conducted the implementation project of the FDA GUDID Content Package. In contrast to the EUDAMED project, migrating the product master data already submitted to GUDID to the UDI Platform was necessary to ensure our customer could continue maintaining and submitting UDI-related data exactly where it was before. Previously, the maintenance processes for the new Content Package were set up and the User Acceptance Test (UAT) was carried out. The cutover for the migration, which was to ensure a smooth transition from the old to the new solution, took place in mid-February.

Since then, the UDI Platform has entirely replaced the SAP MDG-based solution, and the data governance and submission processes of UDI-related data to GUDID, including Audit Trail, were carried out solely using the UDI Platform. In the near future, the UDI Platform installation will be expanded at the customer to other markets within implementation projects for further Content Packages to ensure global UDI compliance. In this context, we have already started realizing the Content Package for South Korea MFDS.

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