Device Master Record (DMR): Definition, Requirements, and What It Includes

A Device Master Record (DMR) is a comprehensive collection of records that detail the procedures and specifications required to manufacture a medical device.

As defined by FDA regulation 21 CFR Part 820.181, the DMR includes approved specifications, production processes, quality assurance procedures, sterilization and environmental controls, packaging and labeling requirements, and maintenance and servicing instructions. These records ensure consistent product quality and regulatory compliance.

While the FDA uses the term DMR, ISO 13485:2016 refers to a similar concept as the “Medical Device File”. The Medical Device File or Technical File serves a similar purpose to the DMR as it provides a complete record of how a device is designed and manufactured.

The DMR serves as a blueprint for manufacturing and differs from related documents such as the Design History File (DHF), which focuses on the design and development process, and the Device History Record (DHR), which captures production history.

Managing DMRs effectively is integral to a Quality Management System (QMS).

Modern QMS software, such as SimplerQMS, facilitates DMR management by offering features like version control, audit trails, document linking, and workflow automation. Book a personalized demo to see how SimplerQMS streamlines DHR management and various other QMS processes.

What Is a Device Master Record (DMR)?

The Device Master Record (DMR) is a comprehensive compilation of all the documentation and information necessary to manufacture a medical device.

DMR includes the approved and released specifications for the finished medical device. It provides detailed descriptions of all components, software, applicable formulations, and compositions. DMR also contains essential manufacturing instructions or processes required to ensure compliance and consistency in production.

As directly defined by the US FDA under 21 CFR Part 820.3 definitions, the meaning of Device Master Record is a compilation of records containing the procedures and specifications for a finished device.

The term “DMR” is specific to FDA regulations. In other regulatory contexts, such as under ISO 13485:2016, a similar concept exists known as the “medical device file” which serves a comparable purpose in detailing the requirements for the production and control of medical devices.

What Is the Purpose of a Device Master Record (DMR) in Medical Device Management?

The primary purpose of the Device Master Record (DMR) is to centralize and organize all the essential records and documentation related to the production of a specific medical device.

The record control and centralization through DMR ensure that every aspect of the manufacturing process is clearly defined, standardized, and readily accessible to relevant stakeholders and regulatory authorities. By consolidating this information, the DMR serves as the source of truth for how the device is manufactured, ensuring that all units produced adhere to consistent customer and regulatory requirements.

Additionally, medical device manufacturers must maintain a DMR to be compliant with FDA requirements, which are critical for market approval and continued compliance. As a key to regulatory compliance, a device master record aligns medical device production with the original design controls and intended use by serving as a linkage between the design phase and the manufacturing process. It translates the design output into actionable, standardized instructions and documentation for production, ensuring the manufactured devices meet the specifications and requirements established during design and development.

What Does a Device Master Record Include?

The device master record typically includes the following.

• Device Specifications: Approved drawings, schematic diagrams, composition, formulation, component specifications, and software specifications.
• Production Processes: Detailed instructions including the appropriate equipment specifications, production methods, production procedures, and production environment specifications
• Sterilization and Environmental Controls: Detailed specifications on sterility methods and validation and environmental monitoring program e.g. for clean room classification and validation
• Quality Control Procedures: Inspection criteria for ensuring the device meets functional and safety specifications, such as testing the battery life and signal output.
• Installation, maintenance, and servicing procedures and methods: A complete list of parts and materials, along with vendor information and acceptance criteria; assembling the medical device, including steps for soldering components, performing software uploads, and calibrating the device.
• Labeling and Packaging Requirements: Instructions for marking the medical device with its unique identifier (ID), applying regulatory symbols, and ensuring integrity and sterility (if applicable).
• References and Linked files: Refer to a feature or area that links the DMR to relevant records, documents, or databases that are kept in other parts of the quality management system (QMS). This section offers references to external files or repositories rather than repeating all pertinent information found in the DMR.

These records are compiled from the aspects of medical device product lifecycle stages to create a DMR. For example, the device master record index for a company manufacturing cardiac pacemakers could include the following items.

A Device Master Record (DMR) index or index file can be saved in QMS software like SimplerQMS. This index file is managed as a controlled document with document versions. DMR index file is updated, reviewed, and approved with a full audit trail to ensure traceability.

What Are the FDA Requirements for a Device Master Record (DMR)?

The FDA requires that manufacturers of medical devices maintain a Device Master Record (DMR) as stipulated in the Quality System (QS) regulation of the FDA under 21 CFR Part 820.181.

FDA 21 CFR Part 820.181 outlines that the DMR must include:

“Each manufacturer shall maintain device master records (DMR’s). Each manufacturer shall ensure that each DMR is prepared and approved in accordance with § 820.40. The DMR for each type of device shall include, or refer to the location of, the following information:

(a) Device specifications including appropriate drawings, composition, formulation, component specifications, and software specifications;

(b) Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;

(c) Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;

(d) Packaging and labeling specifications, including methods and processes used; and

(e) Installation, maintenance, and servicing procedures and methods.”

During audits or inspections, FDA inspectors look for the availability, completeness, and accuracy of the DMR documents. This thorough documentation is essential for manufacturers to demonstrate compliance with FDA regulations and to maintain the integrity and safety of medical devices.

What Are the ISO 13485 Requirements Related to Device Master Records (DMRs)?

The international standard for quality management systems specific to the medical device industry, ISO 13485, does not explicitly use the term “Device Master Record” (DMR) but requires a similar concept known as a “Medical Device File” under section 4.2.3. This requirement ensures comprehensive documentation for design and development controls, aligning with clauses 7.3 for design and development and 7.3.10 for design and development records within the standard.

Section 4.2.3 Medical Device File requires organizations to maintain one or more files for each medical device type or family. These files must contain or reference all necessary documents demonstrating compliance with this International Standard and applicable requirements. The file should include a general description of the device, its intended use, and labeling. It must also contain product specifications, and procedures for manufacturing, packaging, storage, handling, and distribution. Additionally, it should include protocols for measurement and monitoring and, where appropriate, requirements for installation and servicing.

The Medical Device File serves a similar purpose to the DMR in that it provides a complete record of how a device is designed and manufactured. While the FDA’s DMR regulations and ISO 13485’s Medical Device File requirements have different terminologies, the fundamental objective is the same: to preserve efficient documentation and traceability. In order to adhere to both sets of requirements medical device manufacturers must make sure that their documentation is complete, current, and easily accessible for examination.

How Does a DMR Differ from a Design History File (DHF) and a Device History Record (DHR)?

A Device Master Record (DMR), Design History File (DHF), and Device History Record (DHR) are all critical documents in the medical device industry, each serving a distinct purpose set by the US FDA.

The design history file focuses on documenting the design and development history of a medical device. This consists of records of design controls, design verification, and validation activities.

The device master record contains all the information necessary to manufacture the device consistently according to its specifications. It includes device specifications, production process specifications, quality assurance protocols, materials and components, packaging and labeling details, sterilization and environmental controls, and references and linked files. This ensures that every device manufactured will adhere to the same standards and specifications, maintaining product quality and compliance.

The device history record captures the complete manufacturing history of each individual device or batch. It includes data such as the manufacturing date, the operators involved, the serial or lot number, and the results of quality control tests. By providing traceability, the DHR ensures effective monitoring and supports recall processes when necessary.

For a detailed breakdown of the differences and relations between DMR, DHF, and DHR, read our in-depth guide.

What Is the Role of QMS Software in Device Master Record (DMR) Management?

Quality management software is highly beneficial for managing device master records. With robust document management and control features, medical device QMS software centralizes and streamlines DMR-related documents, ensuring they are secure, accessible, and compliant with customer and regulatory requirements.

Key functionalities of QMS software include version control to ensure the use of current documents, secure access for authorized personnel, workflow automation to reduce manual tasks, document linking to maintain connections between records, audit trails for tracking modifications, and unique identification tags for traceability. These capabilities align with FDA 21 CFR Part 820 and ISO 13485 requirements, which demand stringent document control and management.

By implementing QMS software, medical device companies can minimize manual errors, maintain up-to-date records, and simplify audits. SimplerQMS, for example, provides a comprehensive QMS software solution with robust document management capabilities for device master records tailored to the needs of medical device companies. It supports compliance with FDA 21 CFR Part 820 and ISO 13485:2016 while streamlining a wide range of QMS processes. While SimplerQMS can support DMR management, the software has capabilities helpful to other QMS elements such as supplier management, document management, change control, deviation and CAPAs, and training management to mention a few.

For medical device companies seeking to enhance quality management and regulatory compliance, a demo of SimplerQMS can showcase how it optimizes DMR management and strengthens overall quality management efforts.