Knowledge Center

In 2026, medical device manufacturers face mandatory UDI enforcement across the European Union (EUDAMED), Australia (AusUDID), and Switzerland (Swissdamed). Regulators are shifting from system rollout to active compliance oversight, requiring continuous data maintenance, alignment between labeling and database records, and audit-ready transparency. Global manufacturers must implement centralized UDI governance and lifecycle management strategies to reduce regulatory risk and maintain market access.