Unique Device Identification (UDI) System
The UDI system applies to all medical devices, except custom-made and performance study equipment. It enhances device tracking and safety-related activities.
What is UDI?
The Unique Device Identification (UDI) is a unique numerical or alphanumeric code associated with a medical device. It enables clear and unambiguous identification of specific device in the market and facilitates their traceability. UDI consists of the following components:
- Device Identifier (UDI-DI)
- Production Identifier (UDI-PI)
The specificity of UDI enhances the traceability of devices, simplifies device recalls, combats counterfeiting, and enhances patient safety.
UDI will be an addition to, not a replacement for, existing labeling requirements for medical devices.
Learn more about UDI on the European Commission's website: