Medical Device File (MDF)

Quick Definition

The Medical Device File (MDF) is a comprehensive, unified repository of documentation that consolidates three previously separate records required under U.S. FDA 21 CFR Part 820, the Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF), into a single, structured file aligned with ISO 13485 requirements.

What is the Medical Device File (MDF)?

The Medical Device File (MDF) is a comprehensive collection of documentation that provides all essential information about a medical device, including its design, manufacturing processes, specifications, labeling, risk management, and post-market activities. It serves as a central reference that ensures regulatory compliance, supports quality management, and provides traceability throughout the device’s entire lifecycle.

The MDF is the unified documentation framework required under the FDA’s Quality Management System Regulation (QMSR) Final Rule, aligning with ISO 13485. It replaces the Device Master Record (DMR), Device History Record (DHR), and Design History File (DHF) with a single, comprehensive record covering the device’s design, manufacturing, and lifecycle information to meet global regulatory and quality management requirements.

Context and Regulatory Alignment

Under the legacy U.S. QMS framework, DMR, DHR, and DHF served distinct purposes:

• Device Master Record (DMR) – defined the manufacturing processes, labeling, instructions for use (IFU), product specifications, and device description for a specific device.
• Device History Record (DHR) – provided production-level manufacturing information, proof of validation, and quality checks for each batch or unit.
• Design History File (DHF) – documented device design, design control activities, and design outputs throughout the development lifecycle.

Under the QMSR Final Rule, these elements are merged into the Medical Device File, mirroring Annex II of the EU MDR and IVDR, and ensuring full compatibility with ISO 13485. This structure also supports global medtech regulatory expectations, allowing a single MDF to meet the needs of multiple regulatory bodies, including FDA, EU notified bodies, and others.

Components of the Medical Device File

The MDF serves as the single source of comprehensive documentation for a device’s entire lifecycle, from concept to post-market surveillance (PMS). It typically includes:

1. General Description and Intended Use
   • Device description and classification (e.g., Class I).
   • Intended use and performance requirements.
   • UDI (Unique Device Identifier).
2. Design and Development Documentation
   • Design control records.
   • Design outputs and design verification/validation data.
   • Risk management activities per ISO 14971, including risk analysis.
   • Clinical Evaluation Reports (CER) for devices under EU MDR/IVDR.
3. Manufacturing Information
   • Manufacturing processes and controls.
   • Sterilization validation, if applicable.
   • Supplier and traceability records.
   • Templates for process documentation.
4. Product Specifications and Labeling
   • Complete product specifications.
   • Labeling content and packaging requirements.
   • Instructions for use (IFU).
   • Compliance with CFR and EU MDR Annex II labeling requirements.
5. Quality Assurance and Post-Market Surveillance
   • Quality management system procedures.
   • PMS activities and notification processes.
   • Feedback and regulatory requirements tracking.
6. Technical Documentation
   • Aligns with medical device technical file structure.
   • Technical documentation per Annex II (EU MDR/IVDR) for notified body review.

Benefits of the MDF Structure

1. Regulatory Harmonization
   • Simplifies compliance with both FDA and EU MDR/IVDR by unifying technical documentation in a format recognized by global authorities.
2. Streamlined Data Management
   • Eliminates duplication between DMR, DHR, and DHF.
   • Allows medical device companies to save time and resources in data management.
3. Improved Traceability and Quality Assurance
   • Links design outputs, manufacturing processes, and risk analysis to enable full traceability across the device’s lifecycle.
4. Support for Audits and Reviews
   • Facilitates faster, more efficient reviews by regulatory bodies and notified bodies.
   • Serves as the single reference point during regulatory compliance assessments.
5. Enhanced Collaboration
   • Supports integration with other vital product development systems, i.e., PLM, PIM, ERP, and other systems through API connections for real-time updates.

Examples and Use Cases

• Onboarding a New Product: When launching a new product, the MDF can be created from standardized templates, ensuring all device master record elements, technical documentation, and risk management plans are included from the start.
• Post-Market Surveillance Update: Incorporating PMS findings into the MDF ensures that any process improvement or regulatory notification is captured within the same unified structure.
• Regulatory Submission: Submitting the MDF to a notified body for CE marking or to the FDA for clearance simplifies document preparation and shortens timelines.

The transition from DMR, DHR, and DHF to the unified Medical Device File under the QMSR Final Rule marks a major modernization of medical device industry documentation practices. By aligning with ISO 13485 and mirroring the EU MDR/IVDR structure, the MDF delivers a globally recognized, comprehensive documentation framework that improves efficiency, ensures compliance, and strengthens quality assurance throughout the device lifecycle.

For medical device manufacturers, implementing the MDF is not just about meeting regulatory requirements—it is about creating a living, adaptable record that supports product safety, performance, and customer experience in an increasingly integrated global medtech market.