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    Device Master Record

    Compilation of records containing the procedures and specifications for a finished device.

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

    Definition

    Per 21 CFR 820.181, the Device Master Record (DMR) includes device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation/maintenance procedures. Since FDA's Quality Management System Regulation (QMSR) took effect on February 2, 2026, Part 820 incorporates ISO 13485:2016 by reference and no longer uses the DMR term. The same content now lives in the medical device file required by ISO 13485 clause 4.2.3. Many companies keep the DMR name internally, but documents and audits should map to the ISO 13485 structure.
    What the regulation says
    The FDA’s Quality System Regulation (21 CFR Part 820) mandates the establishment of a Device Master Record (DMR) for each type of medical device, as detailed in 21 CFR 820.181. Similarly, the EU Medical Device Regulation (EU MDR 2017/745) does not explicitly name a "DMR" but requires manufacturers to maintain comprehensive technical documentation, as described in Annex II and Annex III, which serves a comparable purpose by consolidating all specifications and procedures related to device design, manufacturing, and quality control. ISO 13485:2016, a standard for medical device quality management systems, in clause 4.2.3, also requires a medical device file for each device type or device family, encompassing its full lifecycle documentation.

    What this means in practice

    The DMR is the source of truth for manufacturing. Inadequate DMR control is a common source of FDA Form 483 observations.

    Examples

    • A manufacturer updates a device’s sterilization parameters; the updated parameters are documented in the DMR to ensure all subsequent production lots use the correct process.
    • During an FDA inspection, an investigator reviews the DMR to verify that the manufacturing processes used for a device lot conform to the documented specifications.
    • A design change to a component necessitates an update to the device specifications within the DMR, which then triggers corresponding updates in production and inspection procedures.
    Common pitfalls
    • •Failing to maintain a DMR as a complete and centralized repository can lead to compliance issues.
    • •Outdated or inaccurate DMR contents can result in manufacturing errors and product non-conformities.
    • •Inconsistencies between the DMR and actual manufacturing practices frequently lead to regulatory observations.
    • •Not adequately controlling changes to the DMR can undermine device quality and regulatory compliance.
    • •A DMR that is difficult to navigate or missing essential information impedes efficient quality management and audits.

    Frequently asked questions

    The primary purpose of a DMR is to serve as the single, authoritative source of information for manufacturing a specific type of medical device, ensuring consistency and quality.

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    Sources

    3 sources

    Sources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 2
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1IMDRF/GHTF·1FDA·1
    1. 1
      21 CFR 820.181
      Tier 1 Verified
      eCFRecfr.gov
    2. 2
      GHTF/IMDRF Process Validation Guidance
      Tier 2 Verified
      IMDRF/GHTFimdrf.org
    3. 3
      FDA - Device Manufacturing
      Tier 2 Verified
      FDAfda.gov

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