The Device Master Record (DMR) is the compilation of records that serves as the manufacturing “master recipe” for a specific medical device. It contains all the procedures, drawings, and specifications needed to produce a finished, compliant product consistently. This documentation is a foundational requirement for quality system compliance and is the blueprint for replicating a device exactly as it was designed and approved.
Purpose and Regulatory Mandate
The primary function of the DMR is to ensure a medical device is manufactured uniformly and consistently according to its established design specifications. It acts as the central source of truth, translating the final product design into actionable instructions for the production floor. This ensures all units of a particular device type meet the same quality and performance standards.
The establishment and maintenance of the DMR is a specific legal requirement for medical device manufacturers operating in the United States. The Food and Drug Administration (FDA) mandates this record under its Quality System Regulation (QSR), specifically in 21 CFR Part 820.181. This regulation requires manufacturers to prove they have documented, approved procedures for quality control and repeatable production.
Although the term “Device Master Record” is specific to the FDA, similar documentation requirements exist under international standards. The ISO 13485 standard, which governs quality management systems for medical devices globally, requires a comparable “Medical Device File.” The objective is the same: to create a complete and traceable record detailing how the device is to be manufactured and controlled.
Essential Documentation Requirements
The DMR is not a single document but a comprehensive collection of records that provide the complete instructions for manufacturing the device. These required records fall into several distinct, mandatory categories.
Device Specifications
The collection must include detailed device specifications, which define the product itself. This involves engineering drawings, a Bill of Materials (BOM) listing every component and raw material, and technical specifications for any software or chemical formulations used. These documents precisely define the finished product.
Production Process Specifications
The DMR also outlines production process specifications, detailing how the device is to be built. This includes manufacturing methods, specific assembly instructions, and the precise settings for production equipment. It also specifies the required production environment, such as cleanroom classifications or humidity controls, to ensure manufacturing conditions do not compromise quality.
Quality Assurance Procedures
Quality assurance procedures and specifications are a mandatory component of the DMR. These documents define the inspection and testing activities that must occur at various stages of production. They establish the acceptance criteria (pass/fail limits) for the device and its components, and specify the quality assurance equipment to be used for testing.
Packaging and Labeling
The final necessary elements cover packaging and labeling specifications. This includes detailed instructions on the packaging materials, methods for sealing and sterilization, and the content and placement of the final product label. For devices requiring setup after shipment, the DMR must also contain installation, maintenance, and servicing procedures to guide end-users or field technicians.
Distinguishing the DMR from DHF and DHR
The DMR is often confused with two other acronyms: the Design History File (DHF) and the Device History Record (DHR). While all three are required under the FDA’s QSR, they serve distinct, sequential purposes in the device lifecycle. Understanding their differences clarifies the DMR’s specific role.
The Design History File (DHF) focuses on the design and development phase. It contains the project history, including design inputs, reviews, verification, and validation testing. The DHF proves the device was developed according to an approved plan and documents the rationale and evidence that led to the final, approved design specifications.
The DMR is the direct output of the DHF’s final stage, known as design transfer. It takes the approved design specifications from the DHF and translates them into the instructions for manufacturing. Therefore, the DHF explains why the device is designed a certain way, while the DMR explains how to build it consistently, acting as the manufacturing template.
The Device History Record (DHR), in contrast, is the record of a specific production run, batch, or unit. The DHR acts as evidence that the manufacturing team successfully followed the instructions laid out in the DMR for that particular lot. It includes details like the dates of manufacture, the quantity produced, and acceptance records showing that the required quality checks were performed and passed.