Device History Record (DHR)

Device History Record (DHR) is the FDA-mandated, per-unit (or per-lot) record proving that a specific medical device was manufactured in accordance with the Device Master Record. It is the as-built genealogy: production dates, quantities, lot/serial numbers, acceptance records, and the labeling that shipped with each device.

What it covers

• Date of manufacture and quantity produced and released.
• Acceptance records for each device — incoming, in-process, and final inspection.
• Primary identification labeling and UDI assigned to each unit.
• Component lots and serials consumed in the build (the medical-device aBOM).
• Reviewer signatures for each release decision.

Relationships (see sidebar)

• Conforms to 21 CFR Part 820 §820.184 and ISO 13485 §7.5.
• Supports Manufacturing Execution, Quality Management, and Warranty and Field Feedback.
• Implemented by MES/QMS platforms including Siemens Opcenter, Aras Innovator, and PTC Arena.
• Sister to the aBOM (the physical genealogy) and the DMR (the manufacturing recipe).