--- title: "DMR, Device Master Record | MedTech Terms" description: "Compilation of records containing the procedures and specifications for a finished device. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. Device Master Record [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply)DMR # Device Master Record Compilation of records containing the procedures and specifications for a finished device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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](/terms/labeling) specifications, and installation/maintenance procedures. What the regulation says The FDA’s [Quality System Regulation](/terms/qsr) (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](/terms/mdr) (EU [MDR](/terms/mdr-reporting) 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](/terms/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](/terms/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 What is the primary purpose of a Device Master Record? 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. How does the DMR relate to design controls? Is a DMR a dynamic document? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Manufacturing Device History Record(DHR) Records demonstrating that a device is manufactured per the DMR. ](/terms/dhr)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls) ### More in Manufacturing · Same category [ Manufacturing Bill of Materials(BOM) Structured list of every component, sub-assembly, and quantity needed to manufacture a device. ](/terms/bom)[ 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) 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 eCFR· 1 IMDRF/GHTF· 1 FDA· 1 1. [1 21 CFR 820.181 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 GHTF/IMDRF Process Validation Guidance Verified IMDRF/GHTF · imdrf.org ](https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-10-2004-qms-process-guidance-04010.pdf) 3. [3 FDA - Device Manufacturing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices) 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 DMR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=dmr) Learn in 60 seconds Card Lesson Quiz Compilation of records containing the procedures and specifications for a finished device. - · The DMR is the source of truth for manufacturing. - · Inadequate DMR control is a common source of FDA Form 483 observations. Remember this Watch out: Failing to maintain a DMR as a complete and centralized repository can lead to compliance issues. Related terms - [Device History Record(DHR) ](/terms/dhr) - [Design Controls ](/terms/design-controls) You may also need Auto-suggested from Manufacturing and shared keywords. - [Quality System Regulation(QSR / 21 CFR 820) ](/terms/qsr) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Process Validation ](/terms/process-validation) - [Production and Process Controls ](/terms/production-process-controls) - [Bill of Materials(BOM) ](/terms/bom) - [Design Transfer ](/terms/design-transfer) [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)