Under the EU MDR, the importance of a robust and well-structured state-of-the-art (SOTA) literature review cannot be overstated. It serves as the foundation of the clinical evaluation process, offering regulators and stakeholders a clear, evidence-based understanding of where a device fits within its clinical context.
In this third episode of our Guide to Clinical Evaluation video series, we explore an overview of the SOTA literature review including its purpose and overall structure. We guide you through its essential components, demystifying the process and explaining how it supports clinical evaluation. You’ll learn how to:
- Place your device in clinical context by outlining the conditions it addresses, its intended use, and how it achieves therapeutic benefit.
- Assess the performance and safety of SOTA devices to understand current clinical expectations and identify relevant comparators.
- Develop safety and performance objectives that define measurable benchmarks for evaluation within the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
We’ll also share our structured approach to conducting these reviews, from defining the clinical background and search strategy to appraising literature and synthesizing data into actionable insights.
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.
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
