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UDI Labelling Requirements

Machine-readable format (barcode/data matrix)​

The complete UDI-K (DI + applicable PI) must appear on the device label in a machine-readable format:

  • GS1 DataMatrix (most common — compact, high data density)
  • GS1-128 barcode (linear)
  • HIBC formats (for HIBCC issuing agency users)

Human-readable form​

For most device types, the UDI-K must also appear in human-readable form adjacent to the barcode/data matrix.

Packaging levels​

Different UDI-K labels are required for:

  • Unit of use — individual device
  • Intermediate packaging (e.g., box of 10)
  • Case / shipping container

Implantable devices​

UDI-K must appear on device packaging AND the production identifier (serial + lot + expiry) must be recorded in the patient's hospital record.