Clinical evaluation is one of the most critical and most challenging aspects of achieving CE marking under the EU Medical Device Regulation (MDR).
At Mantra Systems, we find that it is also the single most common reason for regulatory submissions to fail. Yet, with the right approach, it becomes not just a compliance requirement but an opportunity to demonstrate the safety, performance, and clinical value of a medical device.
That’s why we’re launching our new Guide to Clinical Evaluation Video Series - a step-by-step guide to navigating the process with confidence. Across five episodes, we’ll break down the principles of clinical evaluation, highlight common pitfalls, and share strategies that have helped us deliver more than 300 MDR clinical evaluations with a 100% success rate.
What You’ll Learn in This Series
We’ll walk through each of the key building blocks of clinical evaluation: a
- 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
Our aim is simple: to make the clinical evaluation process clearer, more accessible, and more effective for regulatory teams and manufacturers alike.
Episode One: What is Clinical Evaluation?
In the first video of the series, we begin with the fundamentals: what a clinical evaluation is and what the major components are.
At its core, a clinical evaluation has four main objectives:
- To demonstrate that a device is suitable for its intended purpose.
- To demonstrate conformity with the relevant General Safety and Performance Requirements (GSPRs).
- To demonstrate non-inferiority to safety and performance objectives, derived from the SOTA review.
- To demonstrate the acceptability of the device’s benefit-risk ratio.
Achieving these objectives requires both technical precision and sound scientific judgment. Errors here are costly, often leading to prolonged review cycles or rejection by a Notified Body.
At the heart of achieving these objectives are three essential components of any successful clinical evaluation:
- The State-of-the-Art (SOTA) Review - establishing the clinical benchmark against which your device is measured.
- The Clinical Evaluation Plan (CEP) - mapping out the strategy, scope, and methodology of your evaluation.
- The Clinical Evaluation Report (CER) - presenting the evidence and conclusions that demonstrate compliance.
Together, these three elements form the backbone of a robust clinical evaluation. In this series, we’ll explore each in detail, showing not only how they interconnect, but also how to avoid the common pitfalls that often derail submissions.
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.
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