What is a medical device technical file?
A medical device technical file is a comprehensive collection of documents that contains all the technical information and data related to a medical device to prove that the medical device is safe and effective.
The technical file includes the device description and specification, the basic unique device identifier (UDI), the principles of operation and its mode of action, label and packaging information, instructions for use (IFU) in the languages where the device will be sold, design and manufacturing information, the clinical evaluation plan and clinical evaluation report and more.
What is a medical device technical file used for?
A medical device technical file is an essential part of the medical device conformity assessment process and it demonstrates the device's compliance with applicable regulatory requirements.
The European Union requires a technical file or technical documentation to be submitted to demonstrate that a medical device is compliant with all applicable regulatory requirements. These conditions are stipulated in the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
The terminology differs in the United States (US) where this type of documentation is called the Device Master Record (DMR) and is defined in the FDA regulation CFR Part 820.
Why is a medical device technical file useful?
A medical device technical file is important as it demonstrates the medical device is safe and effective for the intended use. If a device malfunctions or causes harm, the technical documentation is used to find and fix the problems that led to that malfunction or harm. In this case, a medical device technical file is useful for protecting public health and the manufacturer’s reputation.
Why is a CCMS useful for managing medical device technical files?
- It helps manage large amounts of structured content that are required for regulatory compliance.
- It centralizes content for stakeholder accessibility and collaboration.
- It facilitates translation and localization of medical device technical files, ensuring all versions are consistent and accurate.
