In the ever-evolving world of medical device regulation, clinical evaluation is often seen as a standalone exercise. Yet, for manufacturers striving for MDR compliance, it is far more than that; it is the linchpin that connects multiple components of your technical documentation.
In this second episode of our Guide to Clinical Evaluation video series, we explore how clinical evaluation fits into the broader technical file, and how other sections of the file both inform and are informed by it.
At its core, a clinical evaluation demonstrates that a device is safe and effective for its intended purpose. But achieving this requires more than simply compiling clinical studies; it involves integrating insights from across the technical file. Key inputs include intended purpose, clinical evidence, general safety and performance requirements (GSPRs), pre-clinical testing, risk management file, and post-market surveillance.
The beauty of a robust clinical evaluation lies in its dual role: not only does it synthesise inputs from across the technical file, but its outputs also influence other regulatory processes. Clinical findings can prompt updates to the risk management file, inform labelling, or trigger modifications to post-market surveillance plans.
When viewed in isolation, clinical evaluation may appear as a single chapter in the technical file. In reality, it is a central hub, a living document that both draws from and feeds into the broader technical file. By leveraging other components of the technical file, manufacturers can create a clinical evaluation that is not only compliant with MDR but also genuinely insightful, guiding safer and more effective use of medical devices in the real world.
A Proven Framework for Success
At Mantra Systems, we know what success looks like. Our approach to clinical evaluation is built on experience: over 300 successful evaluations conducted under MDR. This track record reflects not just regulatory knowledge, but also a deep commitment to patient safety, clinical relevance, and quality of evidence.
Through this series, we’ll share that expertise with you, helping you avoid the pitfalls we see most often and giving you a clear pathway to stronger, more resilient submissions.
If you missed Episode 1: What is Clinical Evaluation? Catch up here.
Subscribe to our newsletter to keep up with the full five-part series on mastering MDR clinical evaluation, including:
- What is clinical evaluation?
- Clinical evaluation in context
- The State-of-the-Art (SOTA) review – core of a successful submission
- The CEP and CER
- Clinical evaluation pitfalls and useful resources
