--- title: "DHR, Device History Record | MedTech Terms" description: "Records demonstrating that a device is manufactured per the DMR. 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The DHR must demonstrate conformity to the DMR." } }, { "@type": "Question", "name": "Can DHRs be maintained electronically?", "acceptedAnswer": { "@type": "Answer", "text": "Yes, DHRs can be maintained electronically, provided the electronic system complies with requirements for electronic records and signatures, such as those outlined in 21 CFR Part 11." } }, { "@type": "Question", "name": "What is the retention period for DHRs?", "acceptedAnswer": { "@type": "Answer", "text": "According to 21 CFR 820.180, DHRs must be maintained for a period equivalent to the design and expected life of the device, but not less than two years from the date of release for commercial distribution, or as specified in the quality system record." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. Device History Record [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply)DHR # Device History Record Records demonstrating that a device is manufactured per the DMR. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last 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. 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](/terms/dmr) (DMR) and the [quality system regulation](/terms/qsr). EU [MDR](/terms/mdr-reporting) (EU 2017/745) Annex III also implicitly requires similar records for [post-market surveillance](/terms/post-market-surveillance) and traceability purposes. [ISO 13485](/terms/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 What is the primary purpose of a Device History Record? 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](/terms/dmr) and all applicable regulatory requirements. How does the DHR relate to the Device Master Record (DMR)? Can DHRs be maintained electronically? What is the retention period for DHRs? ## 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)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi) ### 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 FDA· 1 ISO· 1 1. [1 21 CFR 820.184 Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 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 DHR Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=dhr) Learn in 60 seconds Card Lesson Quiz Records demonstrating that a device is manufactured per the DMR. - · DHR completeness is an early indicator of manufacturing process control during inspections. Remember this Watch out: 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. Related terms - [Device Master Record(DMR) ](/terms/dmr) - [Unique Device Identification(UDI) ](/terms/udi) You may also need Auto-suggested from Manufacturing and shared keywords. - [Bill of Materials(BOM) ](/terms/bom) - [Lot Traceability ](/terms/lot-traceability) - [Risk Management File(RMF) ](/terms/risk-management-file) - [Design History File(DHF) ](/terms/design-history-file) - [Scrap Rate and Yield ](/terms/scrap-yield) - [UDI-DI vs. UDI-PI ](/terms/udi-di-pi) [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. 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