Expert Panels Don’t Want Your Explanations. They Want Evidence.
You receive questions from the expert panel. Your regulatory team drafts detailed responses explaining why your device is safe, why your clinical data is sufficient, and why your approach is reasonable. You submit confident answers. Then the panel comes back with more questions. Why? Because explanations are not evidence. And most responses fail to distinguish between the two.
The expert panel procedure under MDR Article 106 is not a negotiation. It is not an opportunity to clarify your position or explain your reasoning more eloquently. It is a documented request for specific clinical evidence to close a scientific gap the panel identified in your submission.
When you respond to panel questions with rationales instead of data, you signal that you misunderstood the request. Or worse, that the evidence does not exist.
This is Part 3 of the Expert Panel Procedures series. We have covered when panels intervene and how their questions are structured. Now we address what to actually put in your responses.
What Expert Panels Are Actually Asking For
Panel questions are written as requests for information. But behind each question is a clinical or scientific concern. The panel identified a gap, an inconsistency, or an unsupported claim in your file. The question is their way of asking you to fill that gap with evidence.
The problem is that most responses treat the question as if it were a request for justification. Regulatory professionals draft answers that explain their reasoning. They describe what they intended. They reference guidelines to show they followed process.
But the panel does not need to understand your thinking. They need to see the data that proves your claim.
Panel questions are not invitations to clarify. They are formal evidence requests. The response must contain verifiable clinical data, not arguments or interpretations.
This distinction matters because the panel operates under MDCG 2020-13, which requires them to assess whether the clinical evidence in the technical documentation is sufficient to demonstrate safety and performance. If your response does not add evidence, it does not address their concern.
The Evidence Hierarchy Panels Actually Use
Not all evidence has the same weight in a panel review. You cannot substitute one type of evidence for another and expect the same result. Panels follow a hierarchy based on the strength and directness of the data.
At the top are clinical investigations conducted on your device with a protocol aligned to your intended use and clinical claims. These are the strongest form of evidence because they are device-specific, prospective, and controlled.
Next are equivalence-based data from devices you have demonstrated to be equivalent under MDR Annex XIV criteria. This only works if the equivalence demonstration is valid and if the equivalent device has robust clinical data covering the same claims.
Below that are general scientific literature, registries, and post-market data from similar devices. These can support background or context but cannot be the primary evidence for device-specific claims without a strong justification.
At the bottom are expert opinions, theoretical models, bench testing, and risk assessments. These do not count as clinical evidence under MDR. They may inform your safety analysis, but they do not answer questions about clinical performance.
When a panel asks for evidence of clinical benefit, and you respond with bench test results and a risk-benefit analysis, you are offering the wrong level of evidence. The panel will reject the response because it does not meet their standard.
Responding to clinical performance questions with risk management documents, bench tests, or literature reviews on technology mechanisms instead of patient outcome data from your device or an equivalent device.
WhyFrequently 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
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Deepen Your Knowledge
Read Complete Guide to Clinical Evaluation under EU MDR for a comprehensive overview of clinical evaluation under EU MDR 2017/745.
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
Need Expert Help with Your Clinical Evaluation?
Get personalized guidance on MDR compliance, CER writing, and Notified Body preparation.
✌
Peace, Hatem
Your Clinical Evaluation Partner
Follow me for more insights and practical advice.
Deepen Your Knowledge
Read Complete Guide to Clinical Evaluation under EU MDR for a comprehensive overview of clinical evaluation under EU MDR 2017/745.
