Why Your CER Needs More Than a Literature Review

Your medical device has a 95% success rate. Sounds impressive, right?

But what if similar technologies routinely achieve 99%?

Suddenly, that 95% tells a very different story.

This is exactly why State of the Art (SOTA) matters in a Clinical Evaluation Report (CER).

Many medical device manufacturers invest significant effort in collecting clinical literature, describing medical conditions, and preparing detailed CERs.

Yet, one critical question often remains unanswered:

“How does our device compare with what is currently considered acceptable clinical practice?”

A CER can contain hundreds of references and still have a weak State-of-the-Art section if it fails to establish relevant clinical benchmarks.

Under EU MDR, the objective is not simply to demonstrate that a medical device works.

It is to evaluate whether its safety, clinical performance, and benefit-risk profile are acceptable in the context of current medical knowledge.

Why a Weak State of the Art Can Become a Regulatory Problem

Imagine a manufacturer submitting a CER reporting a 2% complication rate.

The conclusion states:

“The device demonstrates an acceptable safety profile.”

But acceptable compared with what?

Without understanding complication rates associated with current clinical practice, alternative treatments, and comparable technologies, that conclusion may be difficult to defend.

This is where SOTA becomes essential.

A strong SOTA transforms clinical results into scientifically meaningful conclusions.

It establishes the expected safety and performance levels against which the device can be assessed.

State of the Art Is More Than a Literature Summary

One common mistake is filling the SOTA section with disease background and descriptions of competing products.

Although this information provides context, it does not automatically establish meaningful benchmarks.

A strong SOTA should explain current treatment practices, available alternatives, expected clinical outcomes, known complications, relevant clinical guidelines, and unmet medical needs.

Most importantly, it should connect those findings to the device being evaluated.

The purpose of SOTA is not to show how much literature you reviewed. It is to show what that literature means for your device.

Five Common SOTA Mistakes Manufacturers Should Avoid

1. Describing the Disease Without Establishing Benchmarks

A detailed explanation of a medical condition may be useful, but it cannot replace a clinical comparison.

Manufacturers must identify relevant safety and performance expectations from current scientific evidence.

2. Selecting Only Favourable Literature

Choosing studies that make a device appear better creates a biased assessment.

A defensible SOTA should consider relevant favourable and unfavourable findings, including important limitations and uncertainties.

3. Comparing Different Patient Populations

Clinical outcomes from different populations may not be directly comparable.

Patient characteristics, clinical settings, indications, and procedure types should be considered when selecting benchmarks.

4. Ignoring Follow-Up Duration

A 30-day complication rate cannot be directly compared with a five-year outcome without appropriate justification.

Benchmark comparisons should use clinically comparable endpoints and follow-up periods.

5. Failing to Connect SOTA With Risk Management and PMCF

SOTA should help identify expected complications, evaluate clinical claims, and highlight remaining uncertainties.

When important evidence gaps remain, these findings should inform an appropriate PMCF strategy.

What Does a Strong SOTA Actually Demonstrate?

A strong State-of-the-Art section helps answer three important questions:

1. What does acceptable clinical performance look like today?

It identifies meaningful clinical outcomes and benchmarks from relevant scientific evidence.

2. What risks are expected with current treatment options?

It considers known complications, residual risks, and relevant safety expectations.

3. How does the device under evaluation compare?

It evaluates device-specific clinical evidence against the established benchmarks and identifies remaining uncertainties.

When these questions are clearly answered, the SOTA section becomes a valuable foundation for clinical evaluation rather than simply a background chapter.

How Bioexcel Can Help

At Bioexcel, we help medical device manufacturers develop scientifically justified State-of-the-Art assessments for EU MDR Clinical Evaluation Reports.

Our support includes systematic literature searches, clinical guideline review, identification of relevant safety and performance benchmarks, alternative technology assessment, and device-to-SOTA comparison.

We also help align SOTA findings with clinical claims, risk management, benefit-risk conclusions, and PMCF planning.

For manufacturers responding to Notified Body questions, Bioexcel can support the identification and remediation of SOTA evidence gaps.

A detailed CER is not necessarily a defensible CER.

And a lengthy SOTA section is not necessarily a strong SOTA.

The real value of State of the Art lies in establishing objective clinical benchmarks and explaining how the device performs against them.

Before your next Notified Body submission, ask:

“Does our SOTA actually demonstrate whether our device meets current clinical expectations?”

If the answer is unclear, your clinical evaluation may need a closer review.

Contact Bioexcel to request a State-of-the-Art and CER Evidence Assessment.