Comprehensive Guide to Managing Device Master Records (DMR) in Medical Device Manufacturing

1) Purpose

The purpose of this SOP is to establish a standardized approach to creating, maintaining, and managing Device Master Records (DMR) for medical devices. The DMR is a comprehensive document that defines the specifications, production processes, quality assurance procedures, and packaging and labeling requirements necessary to manufacture a device in compliance with regulatory standards.

2) Scope

This SOP applies to all personnel involved in creating, updating, and managing Device Master Records for medical devices manufactured in the facility. It includes document control, periodic reviews, and compliance with regulatory requirements.

3) Responsibilities

– Regulatory Affairs: Ensures that DMRs comply with applicable regulations and guidelines.
– Quality Assurance (QA): Reviews and approves the content of the DMR and ensures its accuracy and completeness.
– Production Team: Provides input related to manufacturing processes and equipment used.
– Document Control Team: Manages document storage, access, and version control for DMRs.
– Design Team: Supplies product design and specification details for inclusion in the DMR.

4) Procedure

4.1 Components of a Device Master Record
4.1.1 Design Specifications
– Include detailed design specifications, such as engineering drawings, dimensions, tolerances, and material requirements.
– Ensure that design specifications align with the device’s intended use and performance standards.

4.1.2 Production Process
– Document all manufacturing processes, including step-by-step instructions, process parameters, and equipment requirements.
– Specify environmental conditions (e.g., temperature, humidity) critical to production.

4.1.3 Quality Assurance Procedures
– Include detailed testing and inspection protocols for raw materials, in-process components, and finished devices.
– Specify acceptance criteria and sampling plans based on applicable standards.

4.1.4 Packaging and Labeling Requirements
– Define packaging materials, methods, and configurations to ensure device integrity during storage and transportation.
– Include labeling requirements, such as content, format, regulatory symbols, and barcode specifications.

4.1.5 Maintenance and Calibration Records
– Document maintenance schedules and calibration requirements for equipment used in manufacturing the device.

4.2 Creation of a Device Master Record
4.2.1 Document Collection
– Gather all necessary documents, including design files, process flowcharts, testing procedures, and labeling templates.
– Verify that all documents are accurate, complete, and up-to-date.

4.2.2 Compilation
– Compile the collected documents into a single, organized record following the standard DMR format.
– Include a table of contents for easy navigation and reference.

4.2.3 Review and Approval
– Submit the compiled DMR to the QA team for review and approval.
– Obtain additional approvals from regulatory affairs or other relevant departments as required.

4.3 Management of Device Master Records
4.3.1 Version Control
– Assign a unique version number to each DMR to ensure traceability of changes.
– Maintain a version history log documenting changes, the rationale for updates, and approvals.

4.3.2 Access Control
– Store DMRs in a secure, centralized document management system with controlled access.
– Grant access only to authorized personnel, based on their roles and responsibilities.

4.3.3 Periodic Review
– Conduct a periodic review of each DMR (e.g., annually or after significant regulatory changes) to ensure continued compliance.
– Document review findings and update the DMR if necessary.

4.3.4 Change Management
– Implement a formal change control process for updating DMRs.
– Use a Change Request Form (CRF) to document proposed changes, including the reason for the change, impact assessment, and required approvals.

4.4 Regulatory Compliance
4.4.1 Alignment with Standards
– Ensure DMRs comply with relevant regulatory standards, such as FDA 21 CFR 820.181 and ISO 13485.
– Include documentation to support compliance, such as risk assessments, validation reports, and regulatory submissions.

4.4.2 Audit Preparation
– Maintain DMRs in a format suitable for regulatory audits and inspections.
– Ensure all supporting documents are readily accessible and properly indexed.

4.4.3 Retention Period
– Retain DMRs for the minimum period specified by regulatory bodies (e.g., at least five years after the device is discontinued).
– Archive superseded versions with appropriate labeling to prevent unintentional use.

4.5 Documentation and Record Keeping
4.5.1 DMR Index
– Maintain an index of all DMRs, including device names, version numbers, and approval dates.
– Update the index promptly when new versions are created or changes are made.

4.5.2 Change Control Log
– Maintain a change control log to record all modifications made to the DMR.
– Include details such as the change description, date, and responsible personnel.

4.5.3 Training Records
– Document training sessions conducted for personnel involved in DMR management.
– Ensure training records are linked to the respective DMR.

5) Abbreviations

– DMR: Device Master Record
– QA: Quality Assurance
– CRF: Change Request Form
– SOP: Standard Operating Procedure

6) Documents

– Device Design Specifications
– Production Process Flowcharts
– Quality Assurance Protocols
– Packaging and Labeling Specifications
– Maintenance and Calibration Records
– DMR Version History Log
– Change Control Log

7) Reference

– FDA CFR Title 21, Part 820.181: Device Master Record
– ISO 13485: Medical devices – Quality management systems
– IEC 60601: Medical electrical equipment standards (if applicable)

8) SOP Version

– Version: 1.0
– Effective Date: DD/MM/YYYY
– Approved by: [Name/Title]

Annexure

Annexure 1: DMR Index Template

Device Name	Version Number	Approval Date	Approved By	Remarks
Device Name	Version 1.0	DD/MM/YYYY	QA Name	Initial Version

Annexure 2: Change Control Log Template

Date	Change Description	Reason for Change	Impact Assessment	Approved By
DD/MM/YYYY	Update to design specifications	Regulatory Requirement	Low Impact	QA Name