Device History Record (DHR)
Quick facts
| Category | Proof-of-manufacture record for a specific device unit or lot |
|---|---|
| Used by | Medical device manufacturing |
| Also called | DHR, eDHR (electronic DHR) |
| Related standards | FDA 21 CFR Part 820, ISO 13485, QMSR |
| Related processes | Device master record, lot traceability, work order management, inspections |
| Semantic match | Device History Record, DHR, eDHR, proof of manufacture, medical device batch traceability |
What is Device History Record (DHR)?
A DHR is the evidence that a specific unit, lot or batch of a device was actually manufactured according to the standardized instructions in the Device Master Record. Where the DMR says how to build the device, the DHR proves that a particular production run genuinely followed those instructions.
Typical DHR content includes the manufacturing dates, the quantity manufactured and the quantity released for distribution, acceptance records confirming the device meets its specifications, and the component or material lot numbers used, supporting full traceability back to specific inputs.
An electronic DHR, or eDHR, digitizes this record, reducing manual data entry errors and simplifying retrieval compared to paper-based batch documentation, while still fulfilling the same evidentiary purpose.
Why is Device History Record (DHR) important?
The DHR is a manufacturer's primary evidence that a specific device unit or batch was produced correctly, supporting confidence in product quality and providing documentation regulators expect during inspections.
Because the DHR captures component and material lot information, it is essential for tracing which specific units might be affected if a quality issue with a particular raw material lot is later discovered, supporting faster, more targeted recalls.
Complete, accurate DHRs also support deviation investigations, giving quality teams the specific production details needed to understand what happened during a particular manufacturing run.
How does Device History Record (DHR) work?
A typical DHR compilation includes:
- Production dates. Record when manufacturing occurred for the specific unit or batch.
- Quantities. Document quantities manufactured and quantities released for distribution.
- Acceptance records. Capture inspection and testing results confirming conformance.
- Lot traceability. Record component and material lot numbers used in production.
- Deviations. Document any deviations from the DMR and their resolution.
- Sign-off. Capture responsible personnel approvals confirming the record is complete.
DHR vs. eDHR
| Comparison | Paper DHR | Electronic DHR (eDHR) |
|---|---|---|
| Data entry | Manual, handwritten | Digital, often auto-populated from production data |
| Retrieval | Physical search required | Instant, searchable access |
Real-world examples of Device History Record (DHR)
A medical device manufacturer compiles a DHR for each production lot, capturing acceptance testing results and component lot numbers used in that specific run.
A company investigating a customer complaint reviews the relevant DHR to confirm which raw material lots were used in the specific unit involved, narrowing the scope of a potential quality investigation.
A manufacturer transitions from paper DHRs to an electronic system, reducing manual transcription errors and speeding up record retrieval during an FDA inspection.
Regulations and standards related to Device History Record (DHR)
The DHR was historically required under FDA 21 CFR 820.184, requiring manufacturers to maintain records demonstrating that each device or batch was manufactured in accordance with the DMR, with ISO 13485 addressing similar production traceability requirements.
Under QMSR, effective February 2026, the DHR's dedicated regulatory citation was removed, though manufacturers must still maintain equivalent production history records under ISO 13485 provisions incorporated by reference.
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How QT9 helps with Device History Record (DHR)
QT9 QMS and ERP DHR capabilities
- Generate electronic Device History Records (eDHR) with single and multi-level support.
- Automatically link production jobs, materials, inspections and approvals to each record.
- Support lot and serial number traceability across every generated record.
- Maintain a transparent, auditable trail from design through production.
- Provide real-time dashboards for faster response to nonconformances.
- Reduce paper-based errors with digital, time-stamped documentation.
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Common mistakes with Device History Record (DHR)
Common mistakes include incomplete lot traceability data within the DHR, which can significantly slow down a recall investigation when trying to identify affected units.
Other problems include relying on manual, paper-based DHR compilation, increasing the risk of transcription errors and making records harder to retrieve quickly during an inspection.
Frequently asked questions
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