The Device Master Record (DMR) is the complete set of instructions and specifications necessary to produce, inspect, package, and service a specific type of finished device. It is the definitive guide for manufacturing operations.

The Device Master Record (DMR) is a fundamental quality record required for medical device manufacturers under the U.S. FDA’s Quality System Regulation (QSR) (21 CFR Part 820, Subpart M).

Mandate: Each manufacturer must maintain Device Master Records (DMR’s) and ensure that each DMR is prepared and approved in accordance with documented control procedures ($\S 820.40$ is referenced for approval).

Origin: The DMR is derived directly from the finished design output. The total finished design output consists of the device, its packaging and labeling, and the Device Master Record.

Required Contents of the DMR

The DMR must either include, or refer to the precise location of, the following information for each type of device:

Device Specifications (The "What")

• Appropriate drawings.
• Composition and formulation.
• Component specifications.
• Software specifications.

Production Process Specifications (The "How to Build")

• Appropriate equipment specifications.
• Production methods.
• Production procedures.
• Production environment specifications.

Quality Assurance Procedures and Specifications (The "How to Check")

• Acceptance criteria.
• The quality assurance equipment to be used.

Packaging and Labeling Specifications

• Packaging specifications.
• Labeling specifications.
• Methods and processes used for packaging and labeling.

Installation, Maintenance, and Servicing

• Installation, maintenance, and servicing procedures and methods.

Relationship to Other Key Records

The DMR is distinct from the other critical records required by the Quality System Regulation:

• Design History File (DHF): The DHF describes the design history of the device, containing the evidence that the design was developed according to the plan.
• Device Master Record (DMR): The DMR contains the instructions and specifications for manufacturing the device.
• Device History Record (DHR): The DHR contains the production history for a specific batch, lot, or unit, demonstrating that it was manufactured in accordance with the DMR. Acceptance records, which demonstrate the device is manufactured in accordance with the DMR, are part of the DHR.
• Rework: Action taken on a nonconforming product (rework) is done so that the product will fulfill the specified DMR requirements before it is released for distribution.
• Final Acceptance: Finished devices cannot be released for distribution until the activities required in the DMR are completed.

DMR in a Changing Regulatory Landscape

While the existing QSR (Part 820) explicitly details the DMR, the new Quality Management System Regulation (QMSR), established in February 2024 and effective February 2, 2026, harmonizes U.S. requirements with international standards like ISO 13485.

Under ISO 13485, the comparable required documentation is referred to as the Medical Device File (MDF). Although the concept and content required are very similar, some formal differences exist between the U.S. DHF/DMR/DHR system and the ISO 13485 files.

‍