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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:

  1. Device Identifier (UDI-DI)
  2. 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:

Traceability (UDI) - information from the European Commission

EU UDI Helpdesk

UDI factsheet (PDF)

Contact us

Units for medical devices

+ 47 22 89 77 00