The introduction of new UDI requirements from countries around the world has fueled an increased focus by regulatory affairs teams. While UDI and other product labeling information have typically been maintained separately from other regulatory information, the growing complexity of supporting multiple markets is introducing compliance challenges. Companies can no longer treat it simply as an operational or supply chain process.
This session will explore UDI requirements across several major markets, including the types of devices that are covered and the expected implementation timelines. We’ll discuss best practices for managing UDI information – including new Basic UDI-DI fields – by centralizing it alongside product registrations, certificates, manufacturing site licenses, and other critical regulatory information.
Learning Objectives:
How products will be impacted by MDR/IVDR as well as other global UDI requirements
Data requirements and issuing entities for different regions
How to curate “universal” UDI data for reuse across country-specific submissions
