Unique Device Identification (UDI)
A globally harmonized system for identifying medical devices throughout their distribution and use. UDI assigns a unique numeric or alphanumeric code to each device, enabling traceability from manufacturer to patient.
Unique Device Identification (UDI) is a standardized system that assigns a unique identifier to every medical device. The UDI consists of two parts: a Device Identifier (UDI-DI) that identifies the device model, and a Production Identifier (UDI-PI) that captures lot number, serial number, expiry date, or manufacturing date.
Regulatory mandates
Both the FDA and EU MDR require UDI labeling, though implementation timelines vary by device class. In the EU, UDI data must be registered in EUDAMED. In the US, UDI data is stored in the FDA's Global Unique Device Identification Database (GUDID). Other regulators — including NMPA, TGA, and Health Canada — are adopting compatible UDI frameworks.
UDI in procurement
Hospital procurement systems increasingly require UDI codes for inventory management, recall tracking, and reimbursement. Tenders may require suppliers to confirm UDI compliance and provide UDI-DI codes for each offered product. Automated procurement platforms use UDI to match devices across contracts and verify product identity.