The requirement for Unique Device Identification (UDI) of Medical Devices and In Vitro Diagnostic Devices has been increasingly implemented in countries around the world to support improved patient safety.
A UDI system is intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier, to be conveyed by using Automatic Identification and Data Capture and, if applicable, its Human Readable Interpretation based upon standard, with the UDI-DI (Device Identifier) of that unique identifier being also linked to a jurisdiction-specific public UDI database.