Device History Record (DHR) is the set of production records proving that a specific device, lot, or batch was built according to its approved Device Master Record. It captures manufacturing dates, quantities made and released, acceptance and test results, labeling used, and unique device identification, and it supports batch release and traceability.
What is a Device History Record (DHR)?
A Device History Record (DHR) is the manufacturing evidence file for a finished device. The Device Master Record (DMR) says how the device should be built. The DHR shows how one particular unit or batch actually was built, by whom, when, with which materials, and against which test results.
The DHR is created during production, not design. It sits downstream of design transfer and upstream of distribution. Nothing ships until a qualified reviewer confirms the record is complete and the device conforms.
Why Device History Record (DHR) matters in medical device development
The DHR is often the first document an inspector asks for. It is the only artifact that connects a serial number in the field to the operator, the component lot, the sterilization cycle, and the release signature behind it.
That connection drives recall scope. A well-built record lets a manufacturer bound a field action to three lots instead of eighteen months of production. A gap in the record forces the conservative assumption, and that assumption is expensive.
Weak production records also invite findings. Missing signatures, uncontrolled corrections, and incomplete acceptance data are recurring inspection observations, and they undermine every downstream claim about product conformity.
Key components of a Device History Record (DHR)
Legacy 21 CFR 820.184 required manufacturers to maintain DHRs showing that each batch, lot, or unit was built in accordance with the DMR. The Quality Management System Regulation (QMSR), effective February 2, 2026, incorporates ISO 13485:2016 by reference, and the terms design history file, device master record, and device history record are no longer named in the regulation. The obligation did not disappear. It moved into ISO 13485 clauses on production records, traceability, and product release.
A conforming record set typically holds:
- Identification and quantity. Device name, model, batch or lot or serial number, quantity manufactured, and quantity released for distribution.
- Dates of manufacture. Start and completion of each controlled production stage.
- Acceptance records. In-process and final inspection and test results, with evidence that acceptance criteria were met before the next step.
- Traceability data. Component, subassembly, and raw material lots consumed. For implantable devices, records of all components used and of work environment conditions, plus sterilization records traceable to specific lots.
- Labeling and packaging. The primary identification label and labeling are used for each production unit, with evidence of the accuracy check performed before release under 21 CFR 820.45.
- Device identification. Under 21 CFR 820.35©, the UDI must be recorded for each medical device or batch of medical devices, in addition to ISO 13485 clauses 7.5.1, 7.5.8, and 7.5.9.
- Release authorization. The identity of the person authorizing release, per ISO 13485 clause 8.2.6.
Clause 7.5.1 governs production under controlled conditions, 7.5.9 covers traceability, and 4.2.5 sets how records are retained and protected. EU MDR 2017/745 imposes parallel expectations through its quality management system and UDI provisions, so one record structure usually satisfies both markets.
Common challenges and best practices
The most common failure is a record designed for the operator rather than the reviewer. Forms that allow free text where a value is expected, or that leave signature blocks ambiguous, generate deviations at review time.
Correction handling is a second recurring problem. Paper entries are corrected with a single line through the error, the correct value, initials, date, and reason. Never obscure the original. Electronic records must capture the original value, the new value, the reason, the user, and a timestamp in an audit trail.
Build the DHR template from the DMR so every specification has a matching record field. Enforce independent review, meaning the person who authorizes release is not the person who performed the operation. Verify the UDI on the record against the UDI on the label, not just against the work order. Where an MES is in use, wire acceptance criteria are entered into the system so a nonconforming value cannot advance the batch.
How SJML helps with Device History Record (DHR)
SJML manufactures medical devices under ISO 13485 and operates to FDA 21 CFR Part 820 and EU MDR and IVDR expectations, across ISO Class 7 and 8 cleanrooms and ESD-controlled areas. Production traceability runs on SAP-integrated MES, which links component lots, in-process inspection, and release records to each batch. The teams handle process validation (IQ, OQ, PQ), PFMEA, PPAP, labeling and packaging validation, and supplier qualification, so the record set reflects a qualified process rather than a paperwork exercise. Regulatory sustenance and QMS remediation support are available where record structures need rework.
Talk to SJML’s manufacturing team →
Frequently asked questions
Yes, in substance. QMSR no longer names the device history record explicitly, but ISO 13485 requires equivalent records. Manufacturers must still keep production, traceability, and release records for each batch, lot, or unit. Most companies keep the DHR name and structure and simply update procedures to cite ISO 13485 clauses 7.5.1, 7.5.9, and 8.2.6 alongside the retained FDA sections.
The DMR is the recipe. It holds specifications, drawings, process instructions, labeling, and acceptance criteria for the device type. The DHR is the proof of execution for one batch, lot, or unit built from that recipe. One DMR generates many DHRs. If the DMR changes through change control, subsequent DHR templates must reflect the new revision.
ISO 13485 clause 4.2.5, as incorporated by QMSR, requires records to be retained for at least the lifetime of the device as defined by the manufacturer, and not less than two years from the date of product release. EU MDR imposes longer periods, especially for implantable devices. Apply the longest applicable period across markets.
Yes. Electronic batch records are standard practice and are usually managed in an MES or eQMS. Systems that create, modify, or store records required by FDA regulation must meet 21 CFR Part 11 for electronic records and electronic signatures, including audit trails, access controls, and validated system operation. Hybrid paper and electronic setups are permitted but harder to defend at inspection.
Related terms
- Device Master Record (DMR)
- Design History File (DHF)
- Batch Record
- Traceability
- Process Validation
