Expert Panels Under MDR: When Compliance Becomes Theater

Written by HATEM RABEH, MD, MSc Ing

Your Clinical Evaluation Expert And Partner

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The MDR introduced mandatory Expert Panel consultations for Class III and implantable devices under Article 61(2). On paper, this requirement aims to strengthen clinical evaluation quality through independent clinical expertise. In practice, I see two patterns emerging: manufacturers who treat Expert Panel consultations as pure compliance exercises, and those who leverage them as genuine clinical validation tools.

The difference between these approaches determines whether your Expert Panel report adds value to your clinical evaluation or simply becomes another document in the technical file that satisfies formal requirements without improving clinical understanding.

The Regulatory Framework for Expert Panel Consultation

Article 61(2) of MDR 2017/745 requires manufacturers of Class III devices and implantable devices to consult with an Expert Panel during clinical evaluation. This consultation must occur before drawing conclusions about clinical safety and performance.

The regulation specifies that Expert Panels shall comprise individuals with appropriate expertise to assess the clinical data. MDCG 2020-17 provides guidance on this requirement, but the document leaves significant room for interpretation regarding panel composition, consultation format, and documentation depth.

What the regulation does not specify is equally important. It does not mandate a specific number of experts. It does not require physical meetings. It does not prescribe a minimum consultation duration. This flexibility creates space for both genuine clinical dialogue and superficial compliance.

Who Qualifies as an Expert Panel Member

The composition of your Expert Panel determines the quality of input you receive. I have reviewed panels ranging from highly specialized clinicians with direct device experience to general practitioners with tangential relevance to the clinical application.

MDCG 2020-17 states that panel members must have appropriate expertise to assess the clinical data for the specific device. This means expertise in the relevant clinical domain, understanding of the disease state or condition being treated, and familiarity with clinical practice in the intended use environment.

Here is where manufacturers make their first critical choice. You can select experts who will challenge your clinical evaluation logic, or you can select experts who will approve what you present. Both approaches can technically satisfy the regulatory text. Only one approach produces valuable clinical validation.

The expertise requirement extends beyond clinical credentials. Panel members should understand clinical evidence hierarchies, be familiar with systematic literature review principles, and be capable of assessing whether clinical data adequately addresses specific safety and performance questions.

Most manufacturers focus only on clinical credentials. A surgeon with 20 years of experience may lack the methodological background to evaluate whether your literature review strategy was appropriate or whether your equivalence claim is clinically justified.

Independence Requirements

Panel members must be independent from the manufacturer. This means no employment relationship, no consultancy agreements beyond the specific panel consultation, and no financial interests that could compromise objectivity.

I see manufacturers struggle with this requirement when they need highly specialized expertise. The pool of qualified experts in niche clinical areas is small. Many have existing relationships with manufacturers. Finding truly independent experts with relevant expertise becomes a practical challenge.

The solution is not to compromise on independence. The solution is to clearly document the selection process, demonstrate due diligence in searching for independent experts, and be transparent about any potential conflicts that remain.

The Consultation Process: Format and Depth

The MDR does not prescribe how the Expert Panel consultation must be conducted. This creates significant variation in how manufacturers approach the process.

Some manufacturers organize formal in-person meetings where panel members review the complete clinical evaluation report, discuss findings in detail, and engage in substantive dialogue about clinical evidence quality. Others distribute the CER electronically, collect written comments, and compile responses into a consultation report.

Both formats can be compliant. But the depth of clinical scrutiny differs dramatically.

What Panel Members Should Review

At minimum, panel members must review the draft clinical evaluation report. But a complete CER can be 200 pages or more. Expecting external experts to thoroughly review such documents without guidance leads to superficial input.

The most effective consultations I have seen involve providing panel members with:

• Executive summary of the clinical evaluation with key findings highlighted
• Specific questions or areas where manufacturer input is needed
• Relevant sections of the full CER rather than the entire document
• Clinical data appendices that are critical to the evaluation

This focused approach allows panel members to provide meaningful input on the aspects that matter most, rather than generic endorsement of the overall document.

Timing Within the Clinical Evaluation Cycle

Article 61(2) requires consultation before drawing final conclusions about clinical safety and performance. This means the consultation must occur when your clinical evaluation is substantially complete but before you finalize your benefit-risk determination.

Manufacturers who consult too early present incomplete evaluations that panel members cannot meaningfully assess. Those who consult too late treat the panel as rubber-stamping a conclusion already drawn.

The optimal timing is when you have analyzed all available clinical data, identified key safety and performance questions, and developed preliminary conclusions that need validation from independent clinical perspective.

Documentation Requirements

The output of your Expert Panel consultation must be documented in a format that demonstrates compliance and captures the substance of the clinical input received.

MDCG 2020-17 does not prescribe a specific template, but the consultation report should include:

• Panel member qualifications and confirmation of independence
• Materials provided to panel members for review
• Questions or topics addressed during consultation
• Panel member input, comments, and recommendations
• Manufacturer responses to panel input
• How panel input influenced final clinical evaluation conclusions

The most valuable consultation reports contain substantive clinical dialogue. They document where panel members questioned your evidence interpretation, where they requested additional data analysis, and where they suggested modifications to your conclusions.

When panel members agree completely with everything you present, either you have done exceptional work or the consultation was not rigorous enough. Most clinical evaluations contain areas of uncertainty, data gaps, or interpretive choices that genuine experts will question.

Integrating Panel Input Into the CER

The Expert Panel consultation is not an isolated activity. It is part of the clinical evaluation process. Panel input should flow directly into your clinical evaluation report.

I review CERs where the Expert Panel consultation report sits in the appendix but the main CER text shows no evidence that panel input influenced the evaluation. This disconnection suggests the consultation occurred after clinical conclusions were already fixed.

The clinical evaluation report should explicitly reference how expert input was considered. When panel members raised concerns about specific safety signals, your CER should address those concerns. When they questioned your equivalence rationale, your final CER should reflect that scrutiny.

Common Implementation Failures

After reviewing dozens of Expert Panel consultations, certain failure patterns repeat consistently.

Consultation as Endorsement Rather Than Scrutiny

Manufacturers present a complete, polished clinical evaluation and ask panel members if they agree with the conclusions. Panel members, often unfamiliar with the depth of analysis required, provide general endorsement. The consultation produces no meaningful clinical validation.

Genuine consultation involves exposing your clinical reasoning to challenge. It means asking experts where your evidence is weakest, where your interpretations might be questioned, and where additional data would strengthen your conclusions.

Generic Clinical Input

Panel members provide comments that could apply to any device in the general category rather than specific input on your clinical evaluation. They confirm that the device type is clinically useful but offer no insight into whether your specific clinical data adequately demonstrates safety and performance.

This happens when panel members lack sufficient detail about your device, your clinical data, or the specific questions your evaluation must address.

Ignoring Inconvenient Panel Input

Panel members raise substantive concerns about data quality, evidence gaps, or unsupported conclusions. The manufacturer documents these concerns in the consultation report but makes no corresponding changes to the clinical evaluation.

If expert clinical input identifies problems with your evaluation, you have two options: address the problems or explain convincingly why the panel’s concerns are not valid. Simply noting their input without action invalidates the consultation.

What Notified Bodies Look For

During document review, Notified Bodies assess not only whether an Expert Panel consultation occurred but whether it served its intended purpose.

Reviewers examine the independence documentation carefully. They check whether panel members have appropriate expertise for the specific device. They assess whether the materials provided to panel members were sufficient for informed input.

Most importantly, they look for evidence that the consultation was substantive rather than superficial. A consultation report showing no substantive discussion, no questions from panel members, and universal agreement raises flags.

Notified Bodies also assess whether panel input actually influenced the clinical evaluation. When panel members identify evidence gaps but the CER claims comprehensive data, the disconnect becomes a finding.

Responding to Notified Body Questions

When Notified Bodies question your Expert Panel consultation, the deficiency often relates to depth rather than format. They may ask for more detailed documentation of panel member qualifications, clearer demonstration of independence, or better evidence that panel input was substantively considered.

The solution is rarely to redo the entire consultation. Usually you need to expand documentation of what actually occurred, provide more detail about panel member expertise relevance, or better demonstrate how their input shaped your conclusions.

Building a Sustainable Expert Panel Strategy

For manufacturers with multiple Class III or implantable devices, Expert Panel consultations become a recurring requirement. Developing a consistent, quality-focused approach is more efficient than treating each consultation as an isolated compliance task.

This means building relationships with qualified, independent experts in relevant clinical domains. It means developing clear processes for how panel consultations are conducted, documented, and integrated into clinical evaluation updates.

It also means investing time in preparing materials for panel review. The quality of input you receive correlates directly with how well you frame the clinical questions that need expert perspective.

Some manufacturers establish standing expert panels for device families. Others engage experts on a device-specific basis. The optimal approach depends on your product portfolio complexity and the availability of appropriately qualified experts.

The Real Purpose of Expert Panel Consultation

The Expert Panel requirement exists because clinical evaluation is fundamentally a clinical judgment exercise. You are determining whether available evidence adequately demonstrates that your device is safe and performs as intended in real clinical use.

This determination involves interpretive choices. How much evidence is sufficient? How do you weigh conflicting study results? When do you accept data from similar devices versus requiring device-specific clinical investigation?

These are not purely technical questions. They require clinical perspective from practitioners who understand the care environment, the patient population, and the clinical consequences of device performance.

Expert Panel consultation, done properly, brings that clinical perspective to bear on your evaluation before you draw final conclusions. It validates that your clinical reasoning withstands scrutiny from independent clinicians.

When manufacturers treat this as a compliance checkbox, they miss the opportunity to strengthen their clinical evaluation through genuine expert input. When they approach it as substantive clinical validation, they often identify and address weaknesses that would otherwise surface as Notified Body findings.

The documentation burden is the same either way. The clinical value differs dramatically.

Next time you prepare an Expert Panel consultation, ask yourself: Are we seeking validation or are we inviting scrutiny? Only one of those approaches serves the requirement’s actual purpose.

Peace,
Hatem
Clinical Evaluation Expert for Medical Devices
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