Design History File (DHF)
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The Design History File is the compiled body of records documenting a medical device’s design history and demonstrating that the finished design was developed in accordance with the approved design and development plan and applicable design control procedures. It aggregates design inputs, outputs, review minutes, verification and validation evidence, and change records generated across the device’s development lifecycle.
A DHF is not necessarily a single physical folder — it is typically an index that points to the underlying design-control records held across engineering, quality, and regulatory systems: the design plan, requirements specifications, risk management file, verification and validation reports, design review minutes, and design transfer records. What matters to an auditor is that the index resolves to a complete, traceable set of evidence for every design-control activity the plan called for.
The DHF is distinct from the Device Master Record and Device History Record, though the three are often confused. The DHF answers “how was this device designed, and was the design controlled?”; the DMR answers “how is this device manufactured?”; the DHR answers “was this specific unit or lot made according to the DMR?” A design-controls inspection typically starts with the DHF and follows its traceability links outward.
Because the DHF spans the full development lifecycle, it is also the first place investigators look when a postmarket complaint or CAPA traces back to a design root cause — gaps in verification coverage, unresolved design review action items, or design changes made without updated risk analysis are common findings.
- —Demonstrates the finished design matches the approved design and development plan
- —Typically an index into distributed records, not one physical file
- —Distinct from the DMR (how it’s made) and DHR (was this unit made correctly)
- —First artifact reviewed in a design-controls inspection
- —Gaps here are a common root cause traced back from postmarket CAPAs
21 CFR 820.30(j) (design controls, pre-QMSR) / FDA QMSR (effective February 2026, incorporating ISO 13485:2016); EU MDR 2017/745 Annex II (technical documentation)
Frequently asked questions
What is Design History File (DHF)?
The Design History File is the compiled body of records documenting a medical device’s design history and demonstrating that the finished design was developed in accordance with the approved design and development plan and applicable design control procedures. It aggregates design inputs, outputs, review minutes, verification and validation evidence, and change records generated across the device’s development lifecycle.
Which regulations cover Design History File (DHF)?
21 CFR 820.30(j) (design controls, pre-QMSR) / FDA QMSR (effective February 2026, incorporating ISO 13485:2016); EU MDR 2017/745 Annex II (technical documentation)