Device Master Record (DMR)

What is Device Master Record?

A Device Master Record (DMR) is a controlled document that contains the detailed specifications, drawings, and manufacturing instructions necessary to produce a medical device. The DMR serves as a blueprint to produce a medical device, ensuring that every device is manufactured consistently and meets the required quality and regulatory standards. It is typically maintained by the device manufacturer and is subject to change control procedures to ensure that any updates or revisions are properly documented and approved.

It includes all the information required to manufacture, test, inspect, package, label, and distribute a device, including:

• Device design specifications
• Material specifications
• Manufacturing process instructions
• Quality control and testing procedures
• Packaging and labeling requirements
• Storage and handling instructions
• Device history records (DHRs)

What are the key features of DMR in pharmaceutical industry?

In the pharmaceutical industry, Device Master Record (DMR) is a critical document that ensures the consistent production of high-quality medical devices, such as injectables, implants, and other pharmaceutical products.

Here are the key features of DMR in the pharmaceutical industry:

• Device Design Specifications: Detailed descriptions of the device’s design, including dimensions, materials, and performance characteristics.
• Bill of Materials (BOM): A comprehensive list of all components, including raw materials, packaging materials, and labeling materials, used to manufacture the device.
• Manufacturing Process Instructions: This section provides step-by-step instructions for manufacturing, assembling, and packaging the device, including process parameters, equipment specifications, and environmental controls.
• Quality Control and Testing Procedures: Detailed descriptions of the quality control and testing procedures used to ensure the device meets the required specifications and standards, including sampling plans, test methods, and acceptance criteria.
• Process Validation: The validation of the manufacturing process, including process validation protocols, reports, and results.
• Change Control: This system plays a vital role in maintaining the integrity of the DMR, including procedures for requesting, reviewing, and approving changes.
• Regulatory Compliance: Ensuring the DMR complies with relevant regulatory requirements, such as the FDA’s Quality System Regulation (21 CFR Part 820) and the EU’s Medical Device Regulation (MDR).