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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 the regulation says
    The UDI-DI (Device Identifier) is a mandatory component of a MedTech product's Unique Device Identification, identifying the specific model or version of a device. The UDI-PI (Production Identifier) captures variable production data, such as lot number, serial number, and expiration date, as required by regulations like the EU MDR (Article 2, Section 15) and FDA UDI Rule (21 CFR 801.3). The FDA's Global Unique Device Identification Database (GUDID) stores UDI-DI information, while UDI-PI data is typically found on the device label and packaging.

    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.

    Examples

    • A manufacturer assigns a new UDI-DI to a revised version of a surgical instrument that has undergone a material change, reflecting the updated device specifications.
    • A medical device is labeled with a UDI-PI that includes a lot number to track specific production batches in case of a quality issue or recall.
    • During an audit, regulators verify that the UDI-DI listed in the MedTech product documentation matches the UDI-DI on the device packaging and in the GUDID.
    Common pitfalls
    • •Assigning an incorrect UDI-DI to a device version can lead to significant regulatory non-compliance and recall issues.
    • •Failing to accurately link UDI-PI data to the correct UDI-DI in regulatory submissions creates data integrity problems.
    • •Using UDI-PI elements inappropriately, such as using a lot number field for a serial number, can result in supply chain disruptions.
    • •Not updating UDI-DI data when device design changes occur leads to outdated and misleading product identification.
    • •Disregarding the Basic UDI-DI as the primary key for device registration in EUDAMED can cause extensive administrative burdens.

    Frequently asked questions

    The UDI-DI uniquely identifies the manufacturer and the specific version or model of a MedTech device. It is a fixed, non-changing component for a given device type.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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.