Completing your Technical File is a conclusive and sometimes final step in launching your Medical Device or In Vitro Diagnostic to market – we can help you to compile your evidence, structure your documentation and ensure alignment with all applicable regulations and standards.
Your product classification and target market determine the level of scrutiny required. This may involve a review of your Technical File by a Notified Body, Approved Body or Regulatory Authority but can also be a self-certification process.
With our team on hand, we can clarify your path to product registration and prepare an appropriate Technical File.
There are three C’s of a good Technical File – we will help you meet all of them:
The Technical File must address all the relevant regulatory requirements and contain all of the evidence required for your reviewer - missing Plans, Records or Reports could prevent your review from progressing even as far as the Technical Reviewer and mean you’ve paid a significant sum for your approver to perform a gap analysis.
If your Technical File is not well-structured or summarised, you will face more questions, more reviewer costs and more approval delays. Our team will ensure a complete understanding of your product to structure a clear and compelling Technical File, ready for approval.
Our regulatory team has the knowledge and experience to make sure your Product’s Technical File fulfils all the evidence requirements and expectations of its reviewer - whether it be a UK Approved Body, EU Notified Body or even the FDA.
The Technical File must address all the relevant regulatory requirements and contain all of the evidence required for your reviewer - missing Plans, Records or Reports could prevent your review from progressing even as far as the Technical Reviewer and mean you’ve paid a significant sum for your approver to perform a gap analysis.
If your Technical File is not well-structured or summarised, you will face more questions, more reviewer costs and more approval delays. Our team will ensure a complete understanding of your product to structure a clear and compelling Technical File, ready for approval.
Our regulatory team has the knowledge and experience to make sure your Product’s Technical File fulfils all the evidence requirements and expectations of its reviewer - whether it be a UK Approved Body, EU Notified Body or even the FDA.
We’ll work with your team to understand your product, its benefits and risks and craft a Technical File that addresses all three C’s to give you a successful and timely approval.
Whether you’ve just got started or nearly finished your Technical File, we can help ensure its Complete, Clear, Changeable and ready for approval.
Regardless of your progress, we’ll craft a Technical File Summary – a cheat sheet for your Technical File that the regulator will use to navigate the documentation, reducing the time they spend reviewing and asking questions, saving you valuable money.
Our expert team can handle the entire process of Regulatory approval from conception to product registration. Explore our complete Regulatory services offering below:
A medical device technical file is a comprehensive collection of documents that provides detailed information about a medical device's design, manufacturing, testing, clinical evaluation, and risk management. This file serves as a crucial resource for regulatory authorities, manufacturers, and other stakeholders to ensure the safety and effectiveness of the device and is the final hurdle in developing product quality documentation prior to approval or release. By maintaining a well-organized and up-to-date technical file, manufacturers can demonstrate compliance with relevant regulatory requirements and standards, facilitate regulatory submissions, and support post-market surveillance activities.
In the UK, EU and US markets (and most markets with medical device regulations), almost all Medical Devices must have a technical file (although the terminology and content is different for each territory). The US FDA has a small list of medical devices that do not require a Technical File (GMP-exempt medical devices) and the UK does not require a technical file for medical devices manufactured by healthcare institutions. All medical devices on the EU market must have a technical file.
Of course. Once we’ve supported you with designing or improving your Technical File, we can also help you address questions from your regulator about the content or submission. Regulators can often speak in their own language, but fortunately our team is fluent in understanding these questions and translating them into actions - without creating unnecessary additional documents or work.
The level of detail required in a technical file depends on the specific device, its intended use, and the regulatory requirements of the target market. Generally, the technical file should contain sufficient information to demonstrate the device's safety and effectiveness, both in its design and software release/manufacturing. It's crucial to consult the specific regulatory requirements of the target market to determine the exact level of detail needed.
Technical Files must be kept up-to-date as the medical device they describe changes - regulators have rules about when they do or do not need to be informed about changes to a medical device, but a technical file must be kept in line with all changes to the medical device. This is why is so important that your Technical File be designed to make it easy to change.
It depends on your device classification and the market you wish to launch your product. Lower risk devices tend not to require submission to a regulator for approval (this is sometimes known as self-certification), whereas higher risk devices can require lengthy approval processes. It’s important to consider the risk class of your medical device at an early stage, so you know what your costs and timelines will be for the process - ranging from no time and no cost to years and hundreds of thousands of Pounds, Euros or Dollars.
Struggling to develop a Complete, Clear and Changeable Technical File? Get in Touch.
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