Medical Device File

Definition of a Medical Device File

A Medical Device file is a comprehensive documentation that provides detailed information about a medical device. It is a crucial component of the regulatory compliance process for medical devices, ensuring that they meet safety and performance standards set by regulatory authorities such as the Food and Drug Administration (FDA) in the United States.

Importance of a Medical Device File

The medical device file is a comprehensive record of the device’s development, testing, and regulatory compliance, providing evidence of its safety and efficacy for approval and ongoing market surveillance. It is typically submitted to regulatory authorities as part of the application process for market authorization or approval to commercialize the device.

Regulatory Requirements for Medical Device Files

The regulatory requirements for medical devices depend on which regulatory body the device is being submitted to. The requirements generally include various documentation about the design and conception of the device design plan, design control form, approved supplier list, test protocols and reports, and risk documentation.

Overview of Regulatory Authorities

FDA- 21 CFR 820 Medical Devices- Quality Systems Regulations

International- ISO 13485:2016

Canada- SOR/98-282 Health Canada

EU- Medical Device Regulation

Types of Medical Devices Requiring an MDF

All medical devices require a medical device file regardless of the risk level classification.

Legal Requirements for Medical Device Files

Legal requirements include

• 21 CFR 820 Medical Devices – Quality Systems Regulations
• 21 CFR 806 Medical Devices– Reports of Corrections and removals
• 21 CFR 11– electronic Records, electronic signatures
• ISO 13485:2016 – Medical devices- quality management systems- Req for regulatory purposes
• SOR/98-282 Medical Device Regulations
• 21 CFR 810– Medical Devices- Medical Devices Recall Authority

Components of a Medical Device File

Design plan

Quality Plan

Risk Management Plan

Design Control

FMEA

Hazard Analysis

Design Transfer plan

Software Documentation