What is a Device Master Record (DMR)?
A device master record, or a DMR, is a file that describes the device and process specifications, production, QA, QC, installation, maintenance, and procedures.
Maintaining a DMR is important to creating a consistent, safe, and effective product. It is also important for regulatory compliance, ensuring traceability and accountability. Facilitating audits and inspections lower risks.
What are the Regulatory Requirements for Device Master Records?
The regulatory requirements for the DMR include necessary information and specifications for the production of each device. This includes device specifications, production processes, quality assurance procedures, packaging and labeling specifications, and other relevant documentation. Document control and version control are important. This record has to be kept 2 years after the device lifecycle.
What are the regulatory bodies that govern the creation and maintenance of DMRs?
- FDA 21 CFR 820
- EU MDR
- Health Canada
What are the specific regulations and standards that outline requirements for DMRs?
- FDA 21 CFR 820- FDA
- SOR /98-282 – Health Canada
- ISO 13485:2016
- 2017/745- EU MDR
Device Master Record Components:
Includes documents about design production, quality control, and distribution.
List of essential documents and information included in a DMR
- Bill of Materials
- Manufacturing SOPs
- Quality Controls Procedures SOPs
- Packaging and Labeling Specifications
- DHR
- Change control procedures
- Regulatory Documentation
- Supplier Documentation
- Records Retention Policy
Design Inputs and Outputs in the DMR
The design inputs and outputs should be documented during design control in a verification and validation process.
Documentation of design outputs to ensure compliance with specifications
Document design outputs prove that the specific design inputs have been fulfilled by design choices.
Production Process Specifications in the DMR
These specifications are carried out through procedures that entail control of measuring and monitoring, incoming inspections, handling, identification, production and process control, calibration, IQ, OQ, and PQ.
Detailed instructions for production processes
Work instructions should provide a detailed process for manufacturing the specific device. They should also include calibration procedures with forms to complete, inspection criteria, and inspection forms.