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    UDI-DI vs. UDI-PI

    Static device identifier (DI) vs. dynamic production identifier (PI) within a UDI.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    A Unique Device Identifier comprises two parts: the Device Identifier (UDI-DI), a static code identifying the labeler and device version, and the Production Identifier (UDI-PI), conveying lot/batch, serial, expiration, or manufacturing date.

    What this means in practice

    EU MDR introduced the Basic UDI-DI as the master key for regulatory documentation in EUDAMED. Mismatched DI/PI assignments are a common cause of EUDAMED registration errors.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2IMDRF/GHTF·1
    1. 1
      FDA UDI
      Verified
      FDAfda.gov
    2. 2
      GHTF/IMDRF Process Validation Guidance
      Verified
      IMDRF/GHTFimdrf.org
    3. 3
      FDA - Device Manufacturing
      Verified
      FDAfda.gov

    Inline markers like [1] jump to the matching reference above.