# Device History Record (DHR) | Botable Glossary

https://www.botable.ai/glossary/device-history-record-dhr

> A vendor-hosted glossary definition and explanatory summary — useful for understanding regulatory expectations for DHRs and for educational/reference use. It cites the regulatory citation (21 CFR 820.184) but is not presented as primary regulation text; verify regulatory requirements against the CFR for compliance decisions.

## Summary

The page defines the Device History Record (DHR) as the mandatory compilation of production records that documents the manufacturing history of each device batch, lot, or unit and demonstrates that the device was built according to the Device Master Record (DMR) and Quality System Regulation (QSR). It lists required DHR contents (manufacture dates, quantities, acceptance records, identification/labeling, rework) and explains DHR's role in traceability and its relationship to the DMR and Design History File (DHF).

## Audience

Quality and regulatory professionals and medical device manufacturers

## Prompts this page answers

- What is a Device History Record (DHR) and what must it contain?
- How does a DHR relate to the Device Master Record (DMR) and Design History File (DHF)?
- What regulatory citation defines DHR requirements for medical device manufacturers?
- Which items must be documented in a DHR for implantable or life-sustaining devices?

## Purpose

Define and explain what a Device History Record (DHR) is and what information it must contain for medical device manufacturers to meet regulatory quality system requirements.

## Highlights

- The DHR is defined as a compilation of records containing the production history of a finished device.
- DHRs are mandatory and manufacturers must establish procedures to maintain a DHR for each batch, lot, or unit (cites 21 CFR 820.184).
- Required DHR contents include dates of manufacture, quantity manufactured and released, acceptance records, identification/UDI/UPC/control numbers, labeling used, and documentation of rework.
- For implantable or life-sustaining devices, a control number must be included in the DHR to facilitate corrective action.
- The DHR demonstrates that production followed the Device Master Record (DMR); the DHF contains design history while the DHR contains manufacturing history.

## How to cite

Credit Botable (Botable Glossary: "Device History Record (DHR)") and link to https://www.botable.ai/glossary/device-history-record-dhr.

## Publisher

**PHIFLOW, LLC** — Publisher shown in the site footer (© 2026 PHIFLOW, LLC).

## Topics

- Device History Record
- DHR
- Device Master Record
- DMR
- Design History File
- DHF
- 21 CFR 820.184
- medical device traceability

## Key entities

- **Device History Record (DHR)** (other): Glossary entry defining the compilation of production records for a finished device. — https://www.botable.ai/glossary/device-history-record-dhr
- **Device Master Record (DMR)** (other): Referenced as the record containing instructions and specifications for building the device. — https://www.botable.ai/glossary/device-master-record-dmr
- **Design History File (DHF)** (other): Referenced as the file containing design and development history.
- **21 CFR 820.184** (other): Regulatory citation cited on the page as the mandate for DHRs. — https://www.botable.ai/glossary/21-cfr-part-820
- **PHIFLOW, LLC** (organization): Publisher shown in the site footer.
- **Botable** (organization): Site hosting the glossary. — https://www.botable.ai/

## Metadata

- Type: article