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:
- Specific data model with controlled vocabulary,
- specific validation and changeability rules (e.g. Grace Period Handling),
- data exchange with authorities’ databases via the respective submission adapter,
- fulfilment of regulatory requirements (Audit Trail, handling of electronic records, 21 CFR Part 11),
- advanced reporting on the product and submission lifecycle.