The Unique Device Identification (UDI) system is already applicable for years in the United States and will become applicable as part of EU Medical Device Regulation (MDR) in May 2020 as well. Many more countries around the globe (e.g. China, Saudi Arabia, India, South Korea) are to follow. Therefore, a forward-looking answer for UDI is unavoidable for Medical Device manufacturers and we provide the strategic SaaS (Software-as-a-Service) solution for the UDI related processes with our UDI Platform.
The UDI Platform is natively built on SAP Cloud Platform, fits seamlessly into heterogenous IT landscapes (SAP and non-SAP) and provides the complete data governance and submission processes of UDI related Product Master Data.
Content Packages are the centerpiece of the UDI Platform. They enable you to cover the requirements of different regulatory authorities, containing the specific data model, data validation rules and the complete handling of exchanging data with the authorities. Based on the managed service approach and regular market monitoring, software updates are provided whenever required for ensuring your continuous UDI compliance.
New Content Package for EUDAMED
Besides the FDA GUDID Content Package, the EUDAMED version is now available and more Content Packages are to follow as soon as other regulatory authorities announce further details about their UDI regulations. They can be added easily to the UDI Platform at any time for worldwide UDI Compliance.
Since EUDAMED data exchange capabilities are not available yet and the date of application for EU MDR in May 2020 is getting closer, the EUDAMED Content Package was released based on the latest available data model definitions and business rules. This enables starting implementation projects right now, resulting in a phased approach for the complete UDI project. The data submission interface to the EUDAMED database will be added as functionality to the EUDAMED Content Package within a later release as soon as the European Commission provides the necessary interface capabilities.
First implementation of EUDAMED Content Package in October
Together with a world-leading medical device manufacturer we started the first implementation project for the UDI Platform with EUDAMED Content Package. The first Go-Live for UDI data maintenance will be in October 2019.
Learn more about UDI Platform: https://www.udiplatform.com