Device History Record (DHR)

A Device History Record (DHR) is the complete, product-specific record that documents how an individual medical device unit or lot was manufactured, tested, and released in accordance with the approved Device Master Record (DMR) and applicable procedures.

What a DHR includes

In regulated manufacturing, especially for medical devices, a DHR typically contains:

• Identification of the product (part number, description, revision, lot/batch and/or serial numbers)
• Reference to the applicable Device Master Record or build specification
• Production dates, lines, and locations where the device was built
• Records of key process steps (e.g., assembly, calibration, sterilization, packaging, labeling)
• Material and component traceability information, as required
• In-process and final inspection and test results, including accept/reject status
• Deviations, nonconformances, rework, and associated approvals
• Signatures or electronic signatures of personnel performing and/or verifying operations
• Final release decision and authorization to ship or use the device

The DHR serves as objective evidence of how each device unit or lot was actually produced and verified, not just how it was intended to be produced.

Operational use in manufacturing systems

In many plants, especially regulated environments, DHR content is captured and maintained using a combination of:

• Manufacturing Execution Systems (MES), often providing electronic DHR (eDHR) functionality
• Electronic batch records or electronic device history record modules
• Quality management systems (QMS) for nonconformance and deviation records
• Enterprise resource planning (ERP) for lot and material genealogy

An MES or related system may guide operators through work instructions, enforce specifications and data collection, and store the resulting records as part of the DHR. In this context, eDHR refers to a DHR held in electronic form with appropriate controls for data integrity, access, and audit trails.

Regulatory and compliance context

The term DHR is most closely associated with medical device regulations, where manufacturers are expected to maintain DHRs for each batch, lot, or unit. While terminology may differ in other regulated industries, similar records exist to demonstrate that manufactured product conforms to approved specifications and documented processes.

What a DHR is not

• It is not the design specification or build recipe itself; that is typically documented in a Device Master Record (DMR) or equivalent.
• It is not a summary quality report, although DHR data may be used to create such reports.
• It is not limited to paper; DHRs can be paper-based, hybrid, or fully electronic.

Common confusion

• DHR vs. DMR: The DMR describes how the device is supposed to be made (product and process definition). The DHR documents how a specific unit or lot was actually made, inspected, and released.
• DHR vs. batch record: In some industries, particularly pharmaceuticals, the term batch record or lot history record is used instead of DHR. The underlying concept is similar: a complete, historical record of the manufacture of a specific batch or lot.
• DHR vs. eDHR: eDHR is simply a DHR maintained in electronic form, typically within MES, QMS, or other validated IT/OT systems.