Device History Record (DHR)

What it is

Device History Record (DHR) is the controlled, unit/lot-specific record proving each device was built, inspected, and released exactly per the approved Device Master Record. It shows dates, quantities, equipment, operators, acceptance results, labeling/UDI, and dispositions. In the U.S., content is defined at 21 CFR 820.184; under FDA’s QMSR the analogous requirement maps to the ISO 13485:2016 production records (e.g., §7.5.1, §7.5.6).

Regulatory framework

• United States (FDA): DHR content/availability (21 CFR 820.184); links to acceptance activities (21 CFR 820.80), nonconforming product (21 CFR 820.90), labeling (21 CFR 820.120), and complaint/servicing records (21 CFR 820.198/820.200).
• QMSR & ISO 13485: QMSR aligns with ISO 13485; maintain device/lot build records, process validations, and release evidence (ISO 13485 §7.5.1, §7.5.6, §8.2).
• EU (MDR): No “DHR” term; maintain batch/device production records within technical documentation and PMS traceability (MDR Annex II–III; Annex I Ch. III; Arts. 27–29 UDI).

Key elements / What it covers

• Identification: Lot/serial numbers, UDI-DI/PI, model/revision, quantity manufactured and released.
• Dates & personnel: Build, inspection, and release dates; operator and QA release signatures.
• Equipment & processes: Lines, equipment IDs, environmental or validated process identifiers.
• Acceptance records: Incoming/in-process/final results, test data, and status labels.
• Labeling & packaging: Final label versions applied, IFU/bundle contents, packaging integrity checks.
• Nonconformities & dispositions: NCR numbers, rework instructions/results, concessions, scrap reconciliation.

Process — how it works

• 1) Prepare controls: Define DHR fields and forms aligned to the DMR and procedures (document control).
• 2) Record production: Capture build steps, equipment IDs, and operator IDs in real time; link to lots and UDI.
• 3) Document acceptance: Record inspections/tests with objective criteria; note pass/fail and any retest.
• 4) Address nonconformities: Open NCRs, define disposition, perform rework per approved instruction, and re-verify before release.
• 5) Release product: QA reviews completeness and signs release; archive DHRs and ensure retrieval on demand.
• 6) Use & maintain: Use DHRs for traceability, complaints, vigilance, recalls, and continuous improvement.

Common pitfalls

• Missing or illegible entries; data not contemporaneous with production.
• Acceptance results recorded without criteria, method, or instrument ID.
• Label/UDI applied that does not match approved masters in the DMR.
• Rework performed without validated instructions or re-inspection records.
• Poor linkage to NCR/CAPA and complaint files, weakening investigations.

Quick checks / Tips

• Can you trace each shipped unit from DHR → DMR spec → acceptance data in minutes?
• Do entries show who, what, when, equipment used, and measured results?
• Are rework and concessions rare, justified, and fully re-verified?
• Does the applied label/UDI match the current approved revision?
• Are DHR retrieval and retention times compliant with policy and law?