Content Packages are the centerpiece of the UDI Platform and enable you to cover the UDI requirements of different regulatory authorities on one platform to achieve global UDI compliance.
The Content Packages are provided as solution extensions on top of the UDI Platform core, allowing you to use the UDI Platform as a central system for all UDI-related maintenance and submission processes of multiple regulatory authorities. Based on our Common Device Model, you can share the core attributes of your medical devices for submissions to different authorities – this approach keeps your UDI data model consistent and enables intelligent derivations rather than gathering data for each market.
Each Content Package consists of:
Start to ensure compliance with FDA and EU MDR / IVDR and add more Content Packages for worldwide compliance at any time.
Based on our experience with already available Content Packages for FDA (GUDID) and EC (EUDAMED), we are currently developing further Content Packages for various markets, including China, Saudi Arabia and South Korea. New Content Packages can be added easily to the UDI Platform at any time and are to follow as soon as other regulatory authorities announce further details about their UDI regulations, so stay tuned!
– Available –
The Content Package includes the GUDID data model with all necessary attributes, validation and changeability rules and the submission handling with GUDID.
– Available –
The Content Package includes the EUDAMED data model with all necessary attributes for MDR / IVDR incl. Basic UDI handling and legacy devices. It is delivered with all validation and changeability rules and the submission handling with EUDAMED (to follow as soon as available at EC).
– Currently under development –
Release planned for second half of 2021.
Contact us for more information.
– Currently under development –
Release planned for second half of 2021.
Contact us for more information.
