Device History Record (DHR)

The DHR is the "birth certificate" or manufacturing log for every specific batch, lot, or individual unit of a device. It answers the question: "Was this specific device built correctly, according to the official instructions?"

The Device History Record (DHR) (21 CFR 820.184) is a mandatory quality record that serves as the official production history for every manufactured medical device.

Device History Record (DHR): Core Definition

Definition: The DHR is formally defined as a compilation of records containing the production history of a finished device.

Mandate: Each manufacturer must establish and maintain procedures to ensure that DHR’s for each batch, lot, or unit are maintained.

Purpose: The DHR must demonstrate that the device was manufactured in accordance with the Device Master Record (DMR) and the requirements of the Quality System Regulation (QSR).

Key Contents of the DHR

The DHR must either include or refer to the location of specific information related to the production and quality control of the device unit or batch:

• Manufacturing Details: The dates of manufacture, the quantity manufactured, and the quantity released for distribution.
• Acceptance Records: The acceptance records which demonstrate the device is manufactured in accordance with the DMR. Documentation of acceptance activities (like tests, results, and the signature of the authorizing individual) are considered part of the DHR.
• Identification and Traceability: The primary identification label and labeling used for each production unit, and any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.
• Labeling Control: The label and labeling used for each production unit, lot, or batch must be documented in the DHR. The release of labeling for use must also be documented in the DHR.
• Rework Documentation: Any actions taken on nonconforming product (rework) and the subsequent reevaluation activities must be documented in the DHR.

DHR's Role in Traceability

The DHR is essential for tracking devices, especially high-risk items:

Control Number: For devices intended for surgical implant or those designed to support or sustain life whose failure could result in significant injury, manufacturers must include in the DHR the control number assigned to each unit, lot, or batch. This procedure is necessary to facilitate corrective action.

Relationship to DMR and DHF:

• Device Master Record (DMR): The DMR contains the instructions and specifications defining how to build the device. The DHR contains the evidence that the production followed those instructions.
• Design History File (DHF): The DHF contains the design and development history. The DHR contains the manufacturing history.

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