UDI (Unique Device Identifier)

A UDI is a unique identifier assigned to a medical device under regulatory requirements in the US, UK, EU and other markets. It allows every device to be tracked individually through manufacture, distribution and clinical use, supporting recall management and post-market surveillance.

UDI is the regulatory foundation of medical device traceability. Without UDI, recall management is slow, post-market surveillance is patchy and adverse event reporting is harder to link back to a specific product. UDI data is held in regulatory databases (the FDA's GUDID in the US and equivalents elsewhere) and increasingly forms the basis of how hospitals identify and track devices internally.