When your clinical evaluation needs an expert panel opinion
I reviewed a clinical evaluation report last month that cited three published studies, performed a statistical analysis, and concluded the device was safe and effective. The manufacturer was confident. The Notified Body rejected it within two weeks. The issue was not the data. The issue was that the clinical data alone could not answer the question the regulation required to be answered.
In This Article
This happens more often than you think. Manufacturers invest months into literature reviews, equivalence demonstrations, and PMCF protocols. They assume that if they gather enough clinical data and present it well, the evaluation is complete.
But MDR introduces a specific mechanism that changes this assumption. Under certain conditions, clinical data is not enough. The evaluation must be supported by an expert panel opinion.
This is not optional. It is a regulatory requirement. And most manufacturers do not realize they are in scope until a Notified Body flags it during review.
What MDR Article 106 Actually Requires
Article 106 of the MDR defines when an expert panel opinion is mandatory. It applies to Class III implantable devices and to certain Class IIb devices that are also implantable or long-term invasive.
The requirement is triggered when the manufacturer relies on clinical data that is not sufficient to demonstrate safety and performance through clinical investigation or other means. This includes cases where equivalence is claimed, but the predicate device itself lacks robust clinical evidence.
What the regulation is saying is simple. If your clinical evaluation is built on indirect evidence, extrapolation, or equivalence claims that carry residual uncertainty, you must consult an expert panel before finalizing your conclusions.
The expert panel is not there to generate clinical data. It is there to interpret clinical evidence when that evidence does not speak for itself with sufficient clarity.
This distinction is critical. Manufacturers often think they can replace missing data with an expert opinion. That is not the purpose. The panel evaluates the weight of existing evidence and determines whether the conclusions drawn are scientifically justified.
When You Are In Scope
Most manufacturers assume they are not in scope because they performed a literature review or because they submitted a clinical investigation report. But scope is determined by the nature of the evidence, not by the volume of documentation.
You are in scope if your device is Class III implantable or Class IIb implantable or long-term invasive, and if your clinical evaluation relies on any of the following:
Equivalence to a predicate device that itself lacks clinical investigation data specific to its intended purpose. This is common with legacy devices that entered the market under earlier directives.
Clinical literature that is not specific to your device but is extrapolated based on shared technology or clinical application. Even if the literature is strong, the extrapolation introduces uncertainty.
A clinical investigation that did not meet the full scope of intended use, user population, or duration of exposure. Partial investigations do not exempt you from expert panel review.
PMCF data that is still maturing and has not yet provided long-term safety signals. If you are relying on post-market surveillance to close evidence gaps, you are in scope during the initial evaluation.
Manufacturers claim equivalence to a well-known predicate without verifying whether that predicate itself has clinical investigation data. The Notified Body then flags the equivalence chain as unsupported and requires an expert panel opinion to interpret the indirect evidence.
The mistake is assuming that a strong equivalence argument removes the need for expert consultation. It does not. If your equivalence claim introduces any inferential step, the regulation assumes that residual uncertainty exists.
What the Expert Panel Actually Does
The expert panel is not a rubber stamp. It is a structured scientific consultation process defined by MDCG 2020-13. The panel must consist of qualified clinical experts who are independent from the manufacturer and who have direct expertise in the relevant clinical domain.
The panel reviews the clinical evaluation report, the technical documentation, and the specific areas where clinical evidence is incomplete or indirect. They do not conduct new studies. They assess whether the conclusions are scientifically justified given the available evidence.
Their opinion is documented in a written report that addresses the following:
Whether the clinical data is sufficient to support the claimed safety and performance.
Whether the residual risks are acceptable given the clinical benefit and the state of the art.
Whether additional clinical investigation or post-market data collection is necessary.
The panel does not approve the device. They provide an opinion on the scientific validity of the clinical evaluation. That opinion becomes part of the technical documentation and is reviewed by the Notified Body during conformity assessment.
If the panel concludes that the evidence is not sufficient, the manufacturer must address the gaps before proceeding. This may require additional clinical investigation, more targeted literature review, or changes to the intended use.
The expert panel opinion is not a procedural formality. It is a scientific checkpoint. If your clinical evaluation has weak points, the panel will expose them. If your evidence is solid, the panel will strengthen your submission.
Why This Gets Missed During Planning
Most manufacturers realize they need an expert panel opinion only after the Notified Body raises it during the review cycle. By then, timelines are compressed and the process becomes reactive.
The reason this happens is simple. Clinical evaluation planning focuses on data generation, not on regulatory interpretation mechanisms. Teams plan their literature searches, their PMCF protocols, and their clinical investigations. But they do not map the clinical evaluation pathway against Article 106 scope criteria.
When you plan a clinical evaluation, you should first determine whether expert panel consultation is required. This decision should be made at the same time you define your equivalence strategy or your clinical investigation scope.
If you are in scope, the expert panel consultation must be integrated into your development timeline. It is not something you bolt on at the end. The panel review may identify evidence gaps that require months to address.
Manufacturers plan for clinical investigation or literature review but do not allocate time for expert panel consultation. When the Notified Body requests an expert opinion, the manufacturer has to restart the evaluation timeline.
This is why I recommend including expert panel scope assessment as a mandatory step in clinical evaluation planning. It should be documented in the clinical development plan alongside your literature search strategy and your PMCF approach.
How to Prepare for Expert Panel Consultation
If you determine that expert panel consultation is required, preparation is critical. The panel will not accept incomplete documentation or vague clinical conclusions.
You must provide the panel with a complete clinical evaluation report, not a draft. The report must include your literature review, your equivalence analysis if applicable, your clinical investigation data if available, and your risk-benefit analysis. The panel cannot fill in gaps for you.
You must also provide clear questions. The panel is not there to write your clinical evaluation. They are there to assess specific areas of uncertainty. Frame your questions around the evidence gaps you identified and the scientific reasoning you applied to address them.
For example, do not ask the panel whether your device is safe. Ask whether the clinical data you presented is sufficient to support the safety conclusions for the intended use and patient population, given the residual risks you identified.
The panel will also expect access to the technical file, including design verification and validation reports, biocompatibility data, and performance testing. Clinical evaluation does not happen in isolation. The panel must understand the device design to assess whether clinical conclusions are technically justified.
The quality of the expert panel opinion depends entirely on the quality of the documentation you provide. If your clinical evaluation report is incomplete or poorly structured, the panel will not be able to provide a meaningful opinion.
What Happens If You Skip It
If your device is in scope and you do not obtain an expert panel opinion, the Notified Body will not grant certification. This is a conformity assessment requirement, not a recommendation.
Some manufacturers try to argue that their clinical data is sufficient and that expert consultation is unnecessary. This argument does not work. The regulation defines scope based on device classification and evidence type, not on manufacturer confidence.
Others try to substitute internal clinical experts for the independent expert panel. This also does not work. The panel must be independent. Internal experts can support the clinical evaluation, but they cannot fulfill the Article 106 requirement.
The consequence of skipping or delaying expert panel consultation is simple. Your submission will be rejected, and you will have to restart the process with the correct regulatory pathway. This can add six months or more to your timeline.
Manufacturers treat expert panel consultation as optional or discretionary. They submit the clinical evaluation without it, assuming the Notified Body will accept their reasoning. The submission is rejected, and the certification timeline is extended.
This is avoidable. If you assess scope correctly during planning and integrate expert panel consultation into your development process, the requirement becomes a managed step rather than a late-stage disruption.
Final Thought
The expert panel requirement exists because clinical evaluation under MDR is not just about collecting data. It is about interpreting that data in the context of regulatory expectations, state of the art, and residual uncertainty.
When your clinical evidence is indirect, extrapolated, or incomplete, you need an independent scientific opinion to validate your conclusions. That is what Article 106 requires.
The question is not whether you will eventually need an expert panel opinion. The question is whether you will plan for it in time to keep your submission on track.
In the next post, I will explain how to select and engage an expert panel that actually adds value to your clinical evaluation.
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). MDR Article 106, MDCG 2020-13
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Peace, Hatem
Your Clinical Evaluation Partner
Follow me for more insights and practical advice.
– Regulation (EU) 2017/745 (MDR), Article 106
– MDCG 2020-13: Clinical Evaluation Assessment Report Template
Deepen Your Knowledge
Read Complete Guide to Clinical Evaluation under EU MDR for a comprehensive overview of clinical evaluation under EU MDR 2017/745.
