Foundation of the UDI System
The Device UDI Requirement was established to create a standardized system for identifying medical devices throughout their distribution and use. A Unique Device Identification (UDI) code contains two main components—the Device Identifier (DI) and the Production Identifier (PI). This combination ensures that each device is traceable, enabling better oversight from regulatory authorities and manufacturers. The UDI system enhances data accuracy, improves recalls, and supports safety monitoring in healthcare environments by ensuring that every product is distinguishable at all stages.
Regulatory Standards and Implementation
Under the Device UDI Requirement, manufacturers must comply with regulations set by authorities such as the FDA, European Commission, and other global bodies. Each region enforces specific data formats, timelines, and database submissions, like the GUDID in the United States or EUDAMED in Europe. These regulations mandate that UDI information be included on product labels and packaging in both human-readable and machine-readable formats. Manufacturers are also responsible for maintaining up-to-date records in designated databases, ensuring transparency and accessibility for regulators and healthcare providers alike.
Impact on Safety and Market Efficiency
The Device UDI Requirement has significantly improved patient safety and market efficiency. Healthcare facilities can now accurately identify defective or expired devices, minimizing risks to patients. The system also enhances supply chain visibility, reduces counterfeit products, and strengthens post-market surveillance. With digital health integration and global adoption increasing, the UDI framework allows seamless device tracking, supports data-driven healthcare decisions, and promotes international regulatory alignment. As a result, the Device UDI Requirement stands as a cornerstone of modern medical device management, combining traceability, accountability, and safety into a unified global standard.