What is the medical device technical file? What should it contain and how should it be structured? And is it even called the medical device technical file anymore?
The medical device technical file (now known simply as the medical device file) is a term used in ISO 13485:2016.
But the file has historically been known by other names in different regulatory regimes.
In the EU MDR and IVDR the same collection of files is referred to as “technical documentation”. The required contents of this file are detailed in Annexes II and III of these regulations.
In the US FDA QSR (Quality System Regulation) a similar collection of files was always known as the Device Master Record.
However, with the harmonisation of ISO 13485 and the QMSR, the US regulator has dropped that name and now refers to the 'medical device file’.
Previously, under the old QSR, the FDA broke down technical documentation requirements into three collections of files:
Device Master Record (DMR): The recipe for your device – all the specifications, drawings, and procedures needed to manufacture it consistently. The ISO 13485 "medical device file" now largely covers the intent and content of the DMR.
Design History File (DHF): The story of how your device was designed and developed to meet user needs. Although ISO 13485 does not refer to the DHF by name, the same document is known as ‘Design and development files’ and is still a requirement, for both the FDA and ISO 13485.
Device History Record (DHR): The proof that you manufactured a specific batch or unit according to the DMR. This concept remains vital for traceability and production control, and the QMSR retains specific requirements related to records like the DHR.
While the FDA's QMSR aligns closely with ISO 13485, it's important to know that some specific US requirements and terminologies (especially concerning records like the DHR or complaint files) might still apply as additions to the ISO 13485 framework.
This isn't just bureaucratic box-ticking. Your technical documentation is vital for several reasons:
Yes.
Clause 4.2.3 of ISO 13485 specifically requires organisations to establish and maintain one or more such files for each device type or family to prove it meets all performance and safety standards.
Even if your device is in a lower-risk category that doesn't require a pre-market review by a regulatory body (like some Class I self-certified devices in the EU or 510(k)-exempt devices in the US), you are still obliged to compile and maintain this technical documentation.
And you must be able to present it if a competent authority requests it.
The exact contents can vary by jurisdiction and device complexity, but common elements, largely driven by ISO 13485 and mirrored in regulations like the EU MDR, include:
Under the FDA QMSR, ensuring your ISO 13485-compliant medical device file covers these areas will be crucial.
Always consult the specific regulations (EU MDR/IVDR, FDA QMSR final rule) for the precise list of required documents.
With so many requirements, structuring this information logically is key. The International Medical Device Regulators Forum (IMDRF) has created helpful Table of Contents (ToC) guidelines for both non-IVD and IVD medical devices. These ToCs provide a standardised framework that is recognised and often preferred by many regulatory authorities worldwide, including the US, EU, Canada, Australia, and Japan. Using the IMDRF ToC can greatly simplify preparing submissions for multiple markets, especially now with the FDA's harmonisation efforts.
Your medical device file isn't a static document you create once and forget. It must be a living file, accurately reflecting the current state of your device, its manufacturing processes, and your understanding of its risks and benefits.
Think of your medical device file as a current snapshot of your device's compliance. Medical Device Quality Consultant Sam Shelley describes it this way:
“The medical device file is the ‘here and now’ documented evidence, which gives all the latest information about the product you are making. It contains all the evidence that your product is currently safe, effective and complies with relevant regulatory requirements and standards.”
So, how does the history of your device's design fit in? And what about the term "Design History File" (DHF)? The DHF provides the historical narrative of how your device was designed and developed.
But…
So, while your quality system processes will align with ISO 13485's requirements for "design and development files," the term DHF remains familiar, is still defined by the FDA, and is widely used in the industry. The critical point is that the requirement to maintain a complete, documented history of your device's design is firmly in place.
As your current medical device file is updated (with, for example, a revised specification or risk assessment), the older, superseded versions of documents that reflect previous design stages must become part of your historical record (AKA DHF or design and development files. This practice preserves the story of your design's evolution.
Sam Shelley explains:
“Creating the technical file [the current snap shot] requires pulling all of the associated documents into a single location, fixed at the version applicable when you create that file. As the product evolves and the documents are revised, the superseded versions of those documents should become part of the Design History File (DHF).
It’s important to remember your medical device file is a continually evolving document.
Following quality audits, you may respond to PMS data by updating your risk management file; you may also need update your SOPs, testing procedures, validation records accordingly. All these changes must be captured in real time, so the file remains a faithful record of your saftey and performance status.
The summary technical file always needs to point to the latest, approved version of each of these quality documents even as they are changed and updated. What’s more, these documents will need to exist simultaneously in different places in your document management system, and be automatically updated in these places when changes are made. In addition, they all need to have a full audit trail available of previous versions to prove they have been subject to appropriate change control.
If there are substantial changes to your product, process or procedures you will need to resubmit your entire Medical Device File to the regulator again. At this point you'll need to create a brand new Design History File that reflects and records all the changes your product has gone through.
The FDA submission process: 510K vs PMA. What’s the difference?
Attempting to manage all this complexity using a paper-based system or something like Google Docs can easily end up in a mess of 1000s of files and file names scattered and duplicated across your servers. Without a centralised, automated system of document and version control you risk making mistakes that can cost you time and money.
You risk misfiling, misnaming or duplicating important documents, leading to broken links and poor navigation within your summary document. This can mean failed audits and significantly slow your route to market.
For more information on this, just read our latest blog about the pros and cons of using Google as a medical device QMS.
Choosing the right document management software that collates documentation within templates as you work, will save you days of filing and frustration.
Not only that, but when major changes are made to your product it can help you manage your Design History File much more efficiently.
As Sam Shelley points out, developers using dedicated eQMS platforms like Cognidox can accomplish big documentation tasks like this with relative ease:
“If you've got a version one of your product and you're now launching version two you can simply ‘archive’ the whole version of that technical file. So it goes from being the medical device file to being the Design History File version in practically one simple action.”
The medical device file is an essential part of your compliance documentation. The summary document with links to all required documents must be easy to navigate, always up-to-date, and ready for inspection on demand.
With the FDA's QMSR embracing ISO 13485, the path towards a more globally consistent approach to medical device documentation is clearer.
But it’s impossible to manage evolving documentation like this without having the right document controls in place. But you should look for tools that can help you meet requirements in the most frictionless way possible.
Last updated on 09/02/2024