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    Device History Record

    Records demonstrating that a device is manufactured per the DMR.

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

    Definition

    Per 21 CFR 820.184, the Device History Record (DHR) contains the production records of a specific batch, lot, or unit of finished device, providing traceability of materials, process steps, and inspections. Under the QMSR, effective February 2, 2026, the DHR term was dropped and production records are covered by ISO 13485 clause 7.5.1 and the record requirements in clause 4.2.5, plus FDA's added record requirements in 820.35. The content is unchanged in practice: quantities made and released, acceptance records, labeling used, and UDI for each unit or lot. Electronic batch records must meet Part 11.
    What the regulation says
    The FDA, in 21 CFR 820.184, mandates that a Device History Record (DHR) be maintained for each lot, batch, or unit to demonstrate that the medical device is manufactured in accordance with the Device Master Record (DMR) and the quality system regulation. EU MDR (EU 2017/745) Annex III also implicitly requires similar records for post-market surveillance and traceability purposes. ISO 13485:2016 clause 7.5.3 outlines requirements for maintaining records for each medical device or batch that provide traceability and identify the amount manufactured and quantity approved for release.

    What this means in practice

    DHR completeness is an early indicator of manufacturing process control during inspections.

    Examples

    • A DHR for a specific lot of sterile syringes would include records of sterilization cycles, quantity produced, inspection results, and the date of manufacture and release.
    • For an implantable pacemaker, the DHR would contain the unique device identification (UDI), records of all components used by lot number, assembly steps, test results, and final packaging information.
    • In the case of a software as a medical device (SaMD), the DHR might include versioning records, build logs, release notes, and verification and validation test reports for a specific software release.
    Common pitfalls
    • •A common pitfall is incomplete DHRs lacking crucial information such as manufacturing dates, quantities, or approval signatures, which can lead to non-conformances during audits.
    • •Misinterpreting "batch," "lot," or "unit" can lead to inconsistencies in DHR creation and insufficient traceability.
    • •Failing to include records of all rework and retesting activities in the DHR can obscure the true manufacturing history of a device.
    • •Not integrating DHRs with a robust electronic quality management system (eQMS) can lead to data integrity issues and inefficient record retrieval during inspections.

    Frequently asked questions

    The primary purpose of a DHR is to provide documented proof that a specific device, batch, or lot was manufactured in accordance with its Device Master Record and all applicable regulatory requirements.

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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· 2Tier 2Regulator guidance and consensus· 1
    Link health: 3 verified· last checked 2026-06-20
    eCFR·1FDA·1ISO·1
    1. 1
      21 CFR 820.184
      Tier 1 Verified
      eCFRecfr.gov
    2. 2
      FDA - Device Manufacturing
      Tier 2 Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Tier 1 Verified
      ISOiso.org

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