SOTA analysis: What reviewers need vs. what they usually get

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The State of the Art analysis is not a literature review exercise. It’s not about demonstrating you can search databases or summarize papers.

It’s a structured analysis meant to demonstrate that your device meets current knowledge and technical performance. That you understand what’s available, what’s accepted, and where your device sits in that landscape.

Most SOTA sections fail because they answer the wrong question.

What the regulation actually requires

MDR Article 61(1) states that manufacturers must demonstrate conformity with general safety and performance requirements. Annex I, Chapter II specifically requires that devices achieve the performance intended by the manufacturer and are designed to achieve appropriate performance in view of the generally acknowledged state of the art.

MDCG 2020-5, the guidance on clinical evaluation, clarifies this further. The SOTA analysis must demonstrate that the device performs as well as or better than alternative treatment options currently accepted in clinical practice.

Notice what’s not mentioned: comprehensive literature collection. Systematic summaries of every paper published.

The requirement is about demonstrating appropriate clinical performance relative to what exists and what’s known.

Yet most SOTA sections read like academic exercises. They collect papers. They summarize findings. They create tables of study characteristics.

But they don’t analyze performance.

The structure that actually works

A functional SOTA analysis starts with the clinical condition, not with the literature search.

What is the medical condition being addressed? What are the relevant patient populations? What are the severity ranges, progression patterns, and clinical outcomes that matter?

This context sets the frame for everything that follows.

Then you define the alternatives. What are the current treatment options? What technologies exist? What approaches are accepted in clinical guidelines?

This is not a marketing comparison. It’s a clinical reality check.

For a surgical implant, the alternatives might include other implant designs, non-surgical management, or different surgical techniques. For a diagnostic device, it might be existing tests, imaging modalities, or clinical assessment methods.

Once alternatives are defined, you establish performance benchmarks. What are the expected clinical outcomes with these alternatives? What does current literature report for safety, effectiveness, and key performance parameters?

This is where literature enters, but in a targeted way.

You’re not collecting every paper on the condition. You’re identifying what performance is considered acceptable, what complication rates are expected, what effectiveness thresholds exist.