When Clinical Claims Go Beyond the Evidence

Your medical device works. Your test results look promising. Your marketing claims sound impressive.

But what happens when a Notified Body asks:

“Where is the clinical evidence supporting this claim?”

This single question can expose weaknesses in an otherwise well-prepared Clinical Evaluation Report (CER).

A manufacturer may have strong engineering data, successful bench testing, and positive clinical results. Yet one unsupported statement in a brochure, website, or Instructions for Use (IFU) can raise questions about the evidence strategy.

Under EU MDR, the challenge is not simply demonstrating that a medical device works.

It is demonstrating that the available evidence supports exactly what the manufacturer claims.

One Device. Three Claims. Three Different Evidence Requirements.

Consider a haemostatic medical device.

The manufacturer has laboratory testing showing that the material absorbs blood efficiently.

Now consider three statements:

Claim 1: “Absorbs blood rapidly.”

This may be supported by appropriate laboratory testing.

Claim 2: “Provides faster haemostasis.”

This introduces a comparative performance claim that requires evidence supporting the comparison.

Claim 3: “Reduces postoperative complications.”

This introduces a clinical outcome claim requiring relevant patient-level evidence.

The device has not changed.

But the regulatory evidence requirements have.

This is where clinical claims and clinical evidence can become misaligned.

The Hidden Problem: Marketing Claims Can Become Regulatory Risks

Medical device marketing teams naturally want to highlight product advantages.

Terms such as “clinically superior,” “faster recovery,” “reduced infection,” and “best-in-class” may attract attention.

However, these statements should not be published without reviewing the supporting evidence.

For example, laboratory testing demonstrating antibacterial activity does not automatically establish that the device reduces infections in patients.

Similarly, acceptable 12-month implant performance does not automatically support a claim of long-term durability.

A scientifically valid result can still be insufficient for an overly broad claim.

Manufacturers should therefore ensure that clinical, regulatory, quality, and marketing teams review important product claims before publication.

Why a 200-Page CER May Still Be Insufficient

A lengthy CER does not automatically mean a strong clinical evaluation.

The critical issue is whether the evidence is relevant to the device, population, intended purpose, and claims being evaluated.

A CER may contain dozens of publications, but if those studies do not address the manufacturer’s claimed clinical benefits, important evidence gaps can remain.

Notified Body reviewers may question whether:

• The clinical endpoints support the claimed outcomes.
• Comparative claims are backed by appropriate comparative evidence.
• Long-term claims have adequate follow-up.
• Device-specific evidence is sufficient.
• Residual risks and claimed benefits are appropriately evaluated.

The value of a CER lies in the strength of its scientific justification, not its page count.

How Manufacturers Can Avoid Unsupported Clinical Claims

A practical approach is to develop a Claims-to-Evidence Matrix before finalizing the CER.

For every major claim, manufacturers should identify the exact wording, type of claim, required evidence, available evidence, limitations, and remaining gaps.

Claims can then be classified as supported, partially supported, unsupported, or requiring additional evidence.

Where evidence is insufficient, the manufacturer may need to strengthen the evidence package, plan appropriate PMCF activities, conduct a clinical investigation, or reconsider the claim itself.

Not every gap requires another clinical study.

Sometimes, revising the wording to reflect what has actually been demonstrated is the more appropriate regulatory strategy.

A Strong Clinical Claim Starts Before the Study

Clinical claims should be considered during study planning, not only after results become available.

The intended claim should influence the study objectives, endpoints, assessment schedule, data collection, and statistical analysis.

The evidence pathway should remain connected:

Clinical Claim → Study Endpoint → Data Collection → Statistical Analysis → Clinical Result → CER Conclusion

When these elements are aligned, manufacturers are better positioned to prepare scientifically defensible clinical evaluations.

How Bioexcel Can Help

At Bioexcel, we help medical device manufacturers assess whether their clinical claims are supported by appropriate evidence.

Our services include Clinical Claims and Evidence Mapping, CER preparation and remediation, literature appraisal, State-of-the-Art analysis, evidence gap assessment, risk management alignment, and PMCF strategy.

Through a structured Claims-to-Evidence Matrix, our team helps identify unsupported claims, clarify evidence requirements, and recommend appropriate regulatory actions.

A strong clinical claim can communicate the value of a medical device.

But when that claim extends beyond the available evidence, it can become a regulatory weakness.

Manufacturers should not focus only on making their products sound better.

They should focus on making every important claim scientifically defensible.

Because the strongest medical device claim is not the one that sounds most impressive. It is the one that can be supported with credible clinical evidence.

Are Your Clinical Claims Supported by Your Evidence?

Before your next CER submission or Notified Body review, make sure your clinical claims and supporting evidence tell the same story.

Contact Bioexcel to request a Clinical Claims and Evidence Review.