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    ManufacturingManufacturing & SupplyBOM

    Bill of Materials

    Structured list of every component, sub-assembly, and quantity needed to manufacture a device.

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

    Definition

    BOMs are released as part of the Device Master Record and drive purchasing, planning, costing, and traceability. Engineering, manufacturing, and service BOMs may differ in level of detail.
    What the regulation says
    Regulators view the Bill of Materials (BOM) as a critical component of the Device Master Record (DMR), essential for establishing and maintaining product conformity, as per 21 CFR Part 820.181 for medical devices in the United States and EU MDR Annex II for devices marketed in the European Union. The BOM supports requirements for design control, production and process controls, and traceability, ensuring that all components and materials used in a medical device meet specified requirements.

    What this means in practice

    BOM accuracy is foundational for UDI assignment, lot traceability, and recall scoping; errors propagate broadly.

    Examples

    • A medical device manufacturer uses the BOM to ensure that all sterile barrier system components are sourced from approved suppliers and meet specific material requirements, maintaining sterility assurance.
    • During a product recall, the BOM helps identify all affected devices by tracing specific lots of a faulty component back to the finished products in which they were used.
    • An auditor reviews the BOM to verify that all critical components listed in the design FMEA are present and correctly specified, aligning with the risk management file.
    Common pitfalls
    • •A common pitfall is failing to maintain an accurate BOM throughout the device lifecycle, leading to discrepancies between the documented and actual device configurations.
    • •Another mistake is not linking the BOM to other critical quality system elements, such as risk management files or design outputs.
    • •Inadequate version control of BOMs can result in the use of obsolete or incorrect components in medical device manufacturing.
    • •Failing to account for software and cybersecurity-related components in the BOM can lead to gaps in addressing software-as-a-medical-device (SaMD) requirements and cybersecurity vulnerabilities.
    • •Not ensuring that supplier changes are reflected in the BOM can result in non-conforming materials being used in production.

    Frequently asked questions

    The primary regulatory purpose is to document all components, raw materials, and sub-assemblies of a medical device, facilitating traceability, quality control, and compliance with design and production specifications outlined in regulations like 21 CFR Part 820 and the EU MDR.
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    ISO·2FDA·1
    1. 1
      ISO 13485 §4.2.3
      Verified
      ISOiso.org
    2. 2
      FDA - Device Manufacturing
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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