Latest / Medical Device Global Market Access
Beyond the Barcode: Mastering MedTech UDI for EUDAMED & Global Markets
This episode delves into the complex realities of Unique Device Identification (UDI) strategy for medical devices. The host explores common blockers that go beyond simple barcode generation, including the nuanced rules for UDI assignment across different packaging configurations, the challenges of carrier placement, and the critical importance of database submission readiness for platforms like EUDAMED. We uncover why mistakes in UDI can cascade into significant traceability and recall issues, and discuss strategies for harmonizing labels across multiple international markets. Key Questions…
The skinny
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