DHRs

DHRs, or Device History Records, are comprehensive records maintained for each batch or unit of a medical device to demonstrate that it was manufactured, inspected, and released in accordance with the device master record and the applicable quality system requirements. A DHR provides traceability from the raw materials and production steps through final disposition and distribution.

A typical DHR includes identifying information such as device model, lot or serial number, manufacture date, and facility. It documents production steps, equipment and process parameters, environmental conditions, and any special handling or sterilization processes used. Inspection and testing results, acceptance criteria, deviations or nonconformities, corrective and preventive actions (CAPA), and the final disposition or release status are also recorded. Packaging, labeling, and storage conditions may be part of the record, along with change history and records of any rework or investigations.

Purpose and use of DHRs center on traceability, accountability, and regulatory compliance. They enable manufacturers to verify that each device unit or lot was produced per specifications, support investigations in the event of a complaint or recall, and facilitate post-market surveillance. DHRs are distinct from the device master record (DMR), which contains the design and manufacturing specifications; the DHR confirms that those specifications were followed in production.

Regulatory frameworks commonly require DHR retention and accessibility, with expectations varying by jurisdiction. In the United States, elements of DHRs align with the FDA’s Quality System Regulation, while other regions reference analogous requirements under ISO 13485 or local regulations.