The Medical Device Technical File – A Roadmap For Compliance

The Medical Device Technical File – A Roadmap For Compliance

29-05-2024

Any medical device destined for the EU market needs a technical file. And if you’ve been following our blog, you know that a vast amount of documentation is needed to get a product certified under the Medical Device Regulation (MDR). That documentation must also be accurate, and structured in the right way.

Whether you’re a newcomer to the medical device market or part of a seasoned medtech team releasing a new type of product, knowing what you need to include, and how to get started with your technical file isn’t easy. That’s why you need a roadmap for compliance.      

The Peercode Pathway

Like everything else in quality management – your technical file starts with a plan. Even for regulatory consultants – like the experts here at Peercode – it takes months to write relevant plans for all the various pieces of documentation: from risk management to post-market surveillance (PMS). 

But that’s just the beginning. To help guide you through, we’ve put together this overview of our end-to-end process. Whilst there’s no precise one-size-fits-all solution, this 4-phase approach works for almost every case, and each phase lasts approximately 3 to 4 months.

The length of each phase can depend on the intended use of your product and its risk class. As a rough rule of thumb, the higher the risk, the more work involved in preparing the technical file, and the longer it can take.

Phase 1 – Planning 

The planning stage is about understanding what your medical device product can and cannot do (intended use), getting your definitions down on paper, and knowing how to validate its functionalities and defining, as well as mitigating, risks. 

Even with templates and expert guidance, it can still be a challenge to get started. Our advice? Just start writing. It’s an iterative process, and getting it right takes time. Expect it to be ‘right first time’ by the final phase.

Phase 2 – Execution

With plans in place, it’s time to collect data, e.g. by testing the product, conducting usability studies, and performing literature review. During this phase, assessing the product against the regulatory requirements helps to surface necessary changes and adjustments. 

Phase 3 – Reporting

Now it’s time for a closer look at the testing results and other activities completed, to draw conclusions from your validation and verification activities. In the final report, you outline your findings and how the identified risks have been mitigated – as far as possible – and how the benefits outweigh any remaining, residual risks.

Phase 4 – Submission

With the technical file complete, it’s time for submission to a relevant Notified Body. After submission, the goal is to have the product certified. But the work doesn’t end there. There’s an ongoing requirement to monitor your medical device product while it is on the market. 

It’s after approval from the Notified Body that your plans for post-market surveillance kick in, and you start to gather feedback and handle complaints. Over time, your technical file will need to be updated with any new evidence, and conclusions made.

In addition, if your product is updated with new requirements or features or a new risk is discovered, this information will need adding to the technical file. 

Feedback from the Notified Body

In an ideal world, a Notified Body would process your technical file, certify the product, and it would be good to go to market. The reality is that your technical file is likely to receive constructive feedback, which will require minor adjustments. 

When technical documents are revised and signed off, the latest approved version becomes the single source of truth, describing what the product is, the risks (and how they’ve been mitigated), as well as proof of the clinical evidence that’s been gathered. 

To a certain extent, this process runs on a loop. Product changes create a cycle of revisions, updates, and approvals over time. However, certain aspects should remain constant as much as possible because changing them impacts every aspect of your technical file and might even trigger recertification or approval by a Notified Body. 

There are 3 changes that would require a complete overhaul of your entire technical file:

  1. The intended use is central to every medical device. 
  2. The intended users are integral to the product design. 
  3. Product family changes have significant ramifications. 

Why quality matters

The Notified Bodies play an important role in safeguarding patient safety, acting as gatekeepers to prevent unsafe products from entering the market, and ensuring medical devices conform to stringent standards. 

The number of low-quality technical files received by the Notified Bodies is part of the reason for the bottleneck in processing applications. It’s not uncommon for a Notified Body to receive an incomplete technical file that’s missing key information and evidence. 

Handling these cases takes time and causes delays. By properly preparing technical files, medtech companies can help ease the bottleneck, and – perhaps more importantly – get their own product certified faster, and ready for the EU market. 

Here at Peercode, our regulatory consultants come from either a medical or technical background. At the same time, we go over and above to truly understand your product so that with our regulatory expertise, we can help you design and research your product in full.  

Need expert support with putting together a technical file for a medical device? Peercode can help! Speak to a regulatory expert