--- title: "BOM, Bill of Materials | MedTech Terms" description: "Structured list of every component, sub-assembly, and quantity needed to manufacture a device. Plain-English Manufacturing definition for MedTech teams, with ex" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/bom#term", "name": "Bill of Materials", "alternateName": "BOM", "description": "BOMs are released as part of the Device Master Record and drive purchasing, planning, costing, and traceability. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. Bill of Materials [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply)BOM # Bill of Materials Structured list of every component, sub-assembly, and quantity needed to manufacture a device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition BOMs are released as part of the [Device Master Record](/terms/dmr) 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](/terms/dmr) (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](/terms/mdr-reporting) Annex II for devices marketed in the European Union. The BOM supports requirements for design control, [production and process controls](/terms/production-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](/terms/udi) assignment, [lot traceability](/terms/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 What is the primary regulatory purpose of a Bill of Materials in MedTech? 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](/terms/mdr-reporting). How does the BOM relate to device traceability? Should a software Bill of Materials (SBOM) be part of the overall BOM? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Device Master Record(DMR) Compilation of records containing the procedures and specifications for a finished device. ](/terms/dmr)[ Manufacturing Lot Traceability Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number. ](/terms/lot-traceability) ### More in Manufacturing · Same category [ Manufacturing Bioburden Quantification of viable microorganisms on or in a product before sterilization. ](/terms/bioburden)[ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). ](/terms/cleanroom-iso-14644)[ Manufacturing Container Closure Integrity(CCI) Demonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life. ](/terms/container-closure)[ Manufacturing Counterfeit Parts and Suspect Components Risk of unauthorized, fraudulent, or substandard components entering the supply chain. ](/terms/counterfeit-parts) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 ISO· 2 FDA· 1 1. [1 ISO 13485 §4.2.3 Verified ISO · iso.org ](https://www.iso.org/standard/59752.html) 2. [2 FDA - Device Manufacturing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Manufacturing Acronym BOM Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=bom) Learn in 60 seconds Card Lesson Quiz Structured list of every component, sub-assembly, and quantity needed to manufacture a device. - · BOM accuracy is foundational for UDI assignment, lot traceability, and recall scoping; errors propagate broadly. - · Engineering, manufacturing, and service BOMs may differ in level of detail. Remember this Watch out: A common pitfall is failing to maintain an accurate BOM throughout the device lifecycle, leading to discrepancies between the documented and actual device configurations. Related terms - [Device Master Record(DMR) ](/terms/dmr) - [Lot Traceability ](/terms/lot-traceability) You may also need Auto-suggested from Manufacturing and shared keywords. - [Engineering Change Order / Notice(ECO / ECN) ](/terms/eco-ecn) - [Software Bill of Materials(SBOM) ](/terms/sbom) - [Device History Record(DHR) ](/terms/dhr) - [Device Master File(MAF) ](/terms/device-master-file) - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [Capitalization Table(Cap Table) ](/terms/cap-table) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)