Your SOTA is not a literature review. Here’s the difference.
I recently reviewed a clinical evaluation report where the manufacturer proudly presented 47 pages of literature summary and called it a State of the Art analysis. The Notified Body rejected it in the first round. Not because the literature was insufficient. But because it was not a SOTA.
In This Article
The manufacturer had done the work. They identified relevant studies. They summarized findings. They built tables. But they missed what the State of the Art actually demands under MDR.
A SOTA is not a literature collection. It is a benchmark analysis. It defines what is currently known, accepted, and achievable in the medical field for your device’s intended purpose. It sets the reference point against which your device will be judged.
And that distinction changes everything.
What the MDR Actually Requires from a SOTA
Article 61(1) of MDR 2017/745 states that clinical evaluation must follow a defined and methodologically sound procedure. Part of that procedure is to identify and analyze the current knowledge about the device and similar devices.
MDCG 2020-5 clarifies that the State of the Art is the developed stage of technical capability at a given time regarding devices, based on consolidated findings of science, technology, and experience.
This is not about summarizing what others have done. It is about defining the current standard of clinical performance, safety, and design in your field.
The SOTA sets the baseline. Your device must meet or exceed it. If your device performs below the SOTA, you must justify why it is still acceptable.
The SOTA is not what your device does. It is what the field currently achieves. Your device is then compared against that benchmark.
Why Manufacturers Confuse SOTA with Literature Review
The confusion is understandable. Both involve literature. Both involve search strategies. Both generate tables and summaries.
But the intent is different.
A literature review collects clinical data to support safety and performance claims. It answers: What does the evidence say about devices like mine?
A SOTA defines the performance and safety threshold in the field. It answers: What is the current benchmark I must meet or exceed?
When you write a literature review, you look for data that supports your claims. When you write a SOTA, you define what “good enough” looks like in your medical field today.
One is about your device. The other is about the standard your device is held against.
Where the Mistake Shows Up
I see this repeatedly in clinical evaluation reports. The SOTA section reads like a summary of clinical studies. It lists outcomes. It presents statistics. But it never declares the benchmark.
The Notified Body reads it and asks: What is the current standard? What performance level do leading devices in this field achieve? What safety profile is expected today?
And the report does not answer.
SOTA sections that list studies without defining the performance threshold, safety benchmark, or current standard in the field. The Notified Body cannot determine if the device meets the SOTA because the SOTA was never defined.
How to Structure a Real SOTA Analysis
A properly written SOTA does not start with studies. It starts with questions.
What is the current standard of care for the medical condition your device addresses?
What devices are currently used in clinical practice for the same intended purpose?
What performance levels do these devices achieve? What complication rates? What procedural outcomes?
What design features are now considered standard in the field?
What safety concerns have been identified and addressed by current devices?
These questions define the scope of your SOTA. The literature search follows to answer them.
Step One: Define the Medical Field and Intended Purpose
You cannot define a SOTA without defining the field. A cardiac stent and a peripheral stent do not share the same SOTA even if they are both stents.
Be precise. Define the medical condition. Define the patient population. Define the clinical setting. Define the intended outcome.
The SOTA is tied to context. Change the context and the benchmark changes.
Step Two: Identify What Currently Exists
This is where literature comes in. But you are not looking for every study. You are looking for devices that represent the current standard.
What devices are currently on the market and widely used?
What do clinical guidelines recommend?
What do recent systematic reviews or meta-analyses reveal about current performance?
You are building a picture of what “normal” looks like in your field today.
Step Three: Define the Performance and Safety Benchmark
Now you declare the standard.
Based on current devices and clinical data, the SOTA for [intended purpose] includes:
- A complication rate of X% or lower
- A clinical success rate of Y% or higher
- Specific design features such as Z
- Known residual risks that are considered acceptable
This is the part most manufacturers skip. They summarize data but never declare the threshold.
The Notified Body needs to see a clear statement: This is what the field currently achieves. This is the bar.
The SOTA must include explicit benchmarks. Not just descriptions of devices or summaries of outcomes. The evaluator must be able to compare your device’s performance directly against the stated SOTA.
What Happens When Your Device Falls Below SOTA
This is the critical moment. If your device does not meet the current SOTA, the MDR does not automatically reject it. But you must justify why it is still acceptable.
Maybe your device addresses a different risk-benefit balance. Maybe it is intended for patients who cannot use current devices. Maybe it trades one performance aspect for a different clinical advantage.
But you must explain it.
If your complication rate is higher than the SOTA, you cannot ignore it. You must acknowledge it, explain why, and demonstrate that the overall benefit-risk remains favorable.
This is where clinical evaluation becomes argumentative. You are not just presenting data. You are making a case.
Why This Matters for Equivalence
If you claim equivalence to another device, the SOTA becomes even more important. Equivalence means your device is as safe and performs as well as the equivalent device.
But if the equivalent device no longer represents the SOTA, equivalence is not enough. You may be equivalent to an outdated device.
I have seen this in legacy devices. The manufacturer claims equivalence to a predicate from 15 years ago. But the field has moved on. The SOTA has evolved. The equivalent device is no longer the standard.
Equivalence to a sub-SOTA device does not demonstrate compliance with MDR.
Claiming equivalence without verifying that the equivalent device still represents the current SOTA. The equivalence may be technically valid but clinically insufficient if the SOTA has advanced.
How Notified Bodies Evaluate Your SOTA
Notified Bodies do not take your SOTA at face value. They check it.
They look for whether the literature search covered the right sources. Whether the devices identified actually represent the current standard. Whether the benchmarks you declare align with what they see in other submissions.
If your SOTA is too narrow, they will challenge it. If it ignores recent developments, they will question it. If it sets the bar too low, they will ask why.
The Notified Body is asking: Did this manufacturer accurately capture what the field currently achieves? Or did they define the SOTA in a way that makes their device look better than it is?
This is not adversarial. It is verification. The SOTA is the foundation of your clinical evaluation. If the foundation is weak, everything built on it is unstable.
What a Strong SOTA Looks Like to a Reviewer
A strong SOTA is transparent about its scope. It explains why certain devices were included and others were not. It references clinical guidelines, recent literature, and real-world use.
It states the benchmark clearly. It does not hide behind vague language like “generally acceptable” or “comparable to existing devices.”
It shows that the manufacturer understands the field. Not just their own device.
When I see a SOTA like this, I know the clinical evaluation that follows will be solid. Because the manufacturer started from the right reference point.
Practical Approach to Writing Your SOTA
Start by defining the clinical context in one paragraph. Be specific about the medical condition, patient population, and intended use.
Identify 3 to 5 devices that currently represent the standard in your field. Not every device on the market. The ones that are widely used and well-documented.
Summarize their performance and safety profile. Use clinical data from instructions for use, published studies, or clinical guidelines.
Declare the benchmark. Write explicit statements about what performance and safety levels are currently achieved.
Compare your device to that benchmark. Show where you meet it. Show where you exceed it. If you fall short anywhere, explain why it is still acceptable.
This structure answers the question the Notified Body is asking: Does this device meet the current standard in the field?
A SOTA is a comparison tool. It must allow the reader to place your device on a scale relative to what currently exists. If the reader cannot make that comparison, the SOTA is incomplete.
Final Thought
The SOTA is not a formality. It is the lens through which your entire clinical evaluation is assessed.
If you define the SOTA accurately, the rest of your clinical evaluation becomes clearer. Your claims are contextualized. Your risks are benchmarked. Your equivalence or clinical data is interpreted correctly.
If you define it poorly, everything downstream is questioned.
The difference between a literature review and a SOTA is the difference between collecting information and setting a standard.
Get the standard right first.
Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
Follow me for more insights and practical advice.
Frequently Asked Questions
What is a Clinical Evaluation Report (CER)?
A CER is a mandatory document under MDR 2017/745 that demonstrates the safety and performance of a medical device through systematic analysis of clinical data. It must be updated throughout the device lifecycle based on PMCF findings.
How often should the CER be updated?
The CER should be updated whenever significant new clinical data becomes available, after PMCF activities, when there are changes to the device or intended purpose, and at minimum during annual reviews as part of post-market surveillance.
What causes CER rejection by Notified Bodies?
Common reasons include inadequate equivalence demonstration, insufficient clinical data for claims, poorly structured SOTA analysis, missing gap analysis, and lack of clear benefit-risk determination. Structure and logical flow are as important as the data itself.
Which MDCG guidance documents are most relevant for clinical evaluation?
Key documents include MDCG 2020-5 (Equivalence), MDCG 2020-6 (Sufficient Clinical Evidence), MDCG 2020-13 (CEAR Template), MDCG 2020-7 (PMCF Plan), and MDCG 2020-8 (PMCF Evaluation Report).
Need Expert Help with Your Clinical Evaluation?
Get personalized guidance on MDR compliance, CER writing, and Notified Body preparation.
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Peace, Hatem
Your Clinical Evaluation Partner
Follow me for more insights and practical advice.
– Regulation (EU) 2017/745 (MDR), Article 61
– MDCG 2020-5: Clinical Evaluation – Equivalence
– MDCG 2020-13: Clinical Evaluation Assessment Report Template
