Medical device development can be a complex and bewildering journey, especially if you're new to the field. One of the areas that often cause confusion is the trio of documentation requirements: the Medical Device File (MDF), Design History File (DHF), and Technical File (TF). If you're feeling perplexed, fear not! We're here to shed light on these essential documents and demystify their roles.
ISO13485 - Medical Device File (MDF): The Blueprint
Imagine you're building a simple Class I medical device, like a basic thermometer. You might think, "Why would I need a Medical Device File for this?" Well, the MDF is your blueprint for design history and manufacturing recipe. A MDF is composed of a design and development file which is similar in content to a DHF and thus the confusion when professionals use the terms interchangeably. While FDA Class I devices don't always require Design Controls, having an MDF ensures you can maintain quality and traceability in the future. The terminology and requirement, Medical Device File, comes from ISO13485:2016 section 4.2.3. Thus, if your organization plans to claim that your QMS is compliant to ISO13485, then you’ll be required to have a Medical Device File. Further details of what’s included in a Medical Device File can be found in ISO13485. We like this short video outlining ISO13485 in a digestible manner.
US FDA - Design History File (DHF): The Journey Map
Now, let's dive into the Design History File, a FDA CFR 820 requirement. Picture it as your journey map through the device's creation. While Class I devices are able to skip this step for FDA, maintaining a DHF can be a smart move. It contains your design control documentation: design inputs, outputs, verification, validation, reviews, and changes. Essentially, it documents the evolution of your device's design and conformance to requirements. Why might you want to do this for a Class I device that doesn't require it? Think of it as future-proofing your Quality Management System (QMS). If you decide to upgrade your device or submit a new product in the future which may be of higher classification, having a DHF already in place can save you time and effort. Typically, DHFs are associated with class II and above devices because the level of risk drives the requirement for design controls. Class I devices are typically exempt from premarket notifications and therefore do not require design controls, which is why many class I devices do not have any file which documents the evolution of the design history. Further, good design control practice allows an organization to record the evolution, and use core deliverables as mechanisms to work with suppliers. As an example may be leveraging design requirements or design outputs (drawings, etc) as tools to hold suppliers accountable for the quality of the parts.
EU MDR - Technical File (TF): The Compliance Portfolio
Now, let's jet over to Europe. If you're aiming to introduce your device in the EU, you'll need a Technical File (TF). This document is your proof of compliance with the European Medical Device Regulation (MDR). It's not specific to device class but is required for all medical devices. Your TF is like a meticulously organized portfolio showcasing your device's safety, performance, and adherence to regulatory requirements. It covers everything from design and risk assessments to clinical evaluations and post-market surveillance. In a lot of ways, it’s similar in content to the core elements one may have in their DHF or Medical Device File but EU MDR also requires specific deliverables which would be documented in the Technical File for submission to the competent authorities or notified body of your choosing.
Class I Device: A Special Case
Finally, let's revisit the Class I device. While the FDA might not require Design Controls, taking the extra step to create a DHF can be a strategic decision. Consider it an investment in your future. If your organization have plans to make improvements, expand your product line, or seek approval for a new device, having a DHF ready can streamline the process when the classification of your devices moves from class I to class II or above. If your organization has plans to enter the European market, a DHF will be a significant base the team can create the Technical File from to submit to the Notified Body for EU approval. In both cases, unless the intent is to remain a class I device for the lifecycle of the device, creating a Design History File, no matter how complete, is strategically smart and forward looking.
To Summarize, a Medical Device File is a term used by ISO13485 to document the design history and final product specifications, manufacturing processes, labeling, and records of any changes to the device or its production. In many ways a Medical Device File is a blend of a Design History File and a Device Master Record (DMR). A Technical File on the other hand goes above and beyond a DHF. A technical file in a lot of ways is a DHF but emphasizes your device's safety, performance, and adherence to regulatory requirements for the European Union. These three files serve distinct purposes in the realm of medical device development and regulation. See the graphical guide below to grasp the main concepts. While Class I devices might not always necessitate extensive documentation, being prepared with an MDF and DHF can safeguard your product's quality and pave the way for future success. So, whether you're building a thermometer or the next groundbreaking medical device, understanding these files is your key to a smooth journey through the maze of regulations and standards.
At Strategies for Medtech, we're committed to partnering with you to navigate these details and ensure your devices meet the standards of safety and performance. Contact us today to learn more.
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