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ROI CalculatorA legally required, centralized record collection document, validating that a medical product is compliant with all applicable safety, quality, and regulatory requirements is referred to as a Medical Device File (MDF). The MDF should include all aspects of the product life cycle. It will provide the complete range of information needed for evaluating the medical device’s safety, efficacy and quality, and verify that the device will function as intended.
The term “Medical Device File” does not exist within the EU medical device regulatory framework, it is referred to instead as an umbrella term for “technical documentation” governing medical devices. The term “Medical Device File” was originally defined in the International Standard for Medical Devices ISO 13485.
In the US, due to recent changes in the applicable legislation, the term “Medical Device File” has become the new overarching term for the storage of technical documentation regarding medical devices, furthermore, the content requirements have also been harmonized with international standards.
The MDF is essential for protecting the safety and health of patients by ensuring that the safety and health of the device is within established tolerances and is a reliable product.
Medical Device Manufacturers must also comply with QMS standards for their products to be able to sell their products after meeting the regulatory requirements of that country. In addition, this documentation demonstrates that the product complies with the standards required and is in accordance with the contours of how a product is designed, developed, manufactured, and tested.
ISO 13485 is the recognized international standard for QMS and is specific to medical devices. If a device manufacturer wishes to declare that the device meets international standards, the manufacturer must establish an ISO 13485-compliant QMS and must maintain a medical device file complete with technical documentation, while also maintaining local office environment laws as needed. All certification processes must also involve the submission of a file to show compliance with all other local processes prior to the issuance of a product certificate. Requirements of the ISO 13485 medical device file include:
Core requirements: All technical files for medical devices must include the following core elements, description of the device, a design of the device, and a manufacturing description of how the device was manufactured. In addition to the above documents, each technical file must contain a documented process for risk management, a post-market surveillance plan, and any other required documents related to the medical device.
Quality Management System: To meet the requirements of ISO 13485:2016, a robust QMS must be set up. The effective management of the medical device file is an integral part of the QMS.
Traceability and repeatability: The documentation included in the medical device files must be well-managed and traceable from the beginning of the device's lifecycle to the time it is removed from the market. Procedures that allow for the traceability and repeatability of the medical device file must be documented.
Document retention timeline: The duration of how long a document must be preserved depends on the document type and your organization’s regulations. As a general guideline, all documents must be retained for at least the lifespan of the medical device or for a minimum of two years after it has been removed from the market, whichever is longer.
