Device History Record (DHR)
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The Device History Record is the compilation of records for a specific finished device unit, lot, or batch, showing it was manufactured in accordance with the Device Master Record. It typically includes the manufacturing dates, quantities produced and released, acceptance records, and the primary identification label and unique device identifier applied to that production run.
The DHR is the device-quality equivalent of a pharmaceutical batch record: it is the after-the-fact evidence that a specific production run followed the specifications the DMR laid down. Where the DMR is a static “how to build it” document, the DHR is a dynamic record generated fresh for every lot.
Investigators pull the DHR for a specific complaint sample or recalled lot to reconstruct exactly what happened during that run — which operators, which equipment, which in-process test results, and whether every acceptance activity the DMR requires was actually performed and recorded before release.
A DHR with missing entries, undocumented deviations, or acceptance signatures that do not trace to a qualified person is a common 483 observation, and it is also the record a manufacturer relies on to scope a recall to the affected lots only.
- —Records that a specific unit, lot, or batch was made per the DMR
- —Includes manufacturing dates, quantities, acceptance records, and UDI/labeling applied
- —The device-quality analogue of a pharmaceutical batch record
- —Used to reconstruct events for a specific complaint sample or recalled lot
- —Missing or unsigned entries are a common inspection finding
21 CFR 820.184 (Device History Record, pre-QMSR); FDA QMSR (effective February 2026, incorporating ISO 13485:2016); EU MDR 2017/745 Annex II
Frequently asked questions
What is Device History Record (DHR)?
The Device History Record is the compilation of records for a specific finished device unit, lot, or batch, showing it was manufactured in accordance with the Device Master Record. It typically includes the manufacturing dates, quantities produced and released, acceptance records, and the primary identification label and unique device identifier applied to that production run.
Which regulations cover Device History Record (DHR)?
21 CFR 820.184 (Device History Record, pre-QMSR); FDA QMSR (effective February 2026, incorporating ISO 13485:2016); EU MDR 2017/745 Annex II