DMR

A Device Master Record (DMR) is a compilation of records required by FDA 21 CFR 820.181 that contains the complete manufacturing procedures and specifications for a finished medical device. The DMR serves as the "recipe" for how to manufacture the device.

What the DMR must contain:

1. Manufacturing Specifications
- Device specifications and drawings
- Bill of materials (BOM)
- Component specifications
- Labeling and packaging specifications

2. Production Process Procedures
- Manufacturing methods and processes
- Process controls and parameters
- Assembly instructions
- Quality control procedures
- Acceptance criteria

3. Installation and Servicing
- Installation procedures (if applicable)
- Servicing procedures
- Maintenance procedures

4. Additional Documentation
- Software installation procedures
- Calibration requirements
- Environmental controls
- Sterilization parameters (if applicable)

DMR vs DHF vs DHR - Key differences:

• DMR (Device Master Record) - HOW to manufacture the device

• DHF (Design History File) - WHY the device was designed this way

• DHR (Device History Record) - PROOF a specific unit was manufactured correctly

Regulatory requirements:
- FDA 21 CFR 820.181 - Device Master Record
- ISO 13485:2016 Section 4.2.3 - Control of Documents
- EU MDR Technical Documentation requirements

When DMR must be updated:
- Manufacturing process changes
- Component or material changes
- Specification changes
- New or modified procedures
- Corrective actions affecting manufacturing

Common FDA 483 observations:
- Incomplete manufacturing procedures
- Undocumented process changes
- Missing specifications or drawings
- Poor document control
- Lack of traceability to DHF

The DMR is essential for consistent manufacturing and is reviewed during FDA inspections to ensure reproducible device production.