The European Association of Medical Devices Notified Bodies, Team-NB, has published a new position paper examining the role and experience of Expert Panels under Article 54 of Regulation (EU) 2017/745 (MDR).
Adopted on 3 November 2026, the paper provides a detailed assessment of the Clinical Evaluation Consultation Procedure (CECP) and identifies several areas where Team-NB believes the system could be improved as part of future MDR revision discussions.
CECP Remains an Important Safety Mechanism
The CECP was introduced under Article 54 MDR to provide an additional level of independent scientific scrutiny for certain high-risk medical devices before certification.
According to Team-NB, the procedure aims to:
strengthen patient safety;
improve confidence in regulatory decision-making;
promote consistency in the evaluation of clinical evidence across Europe.
Team-NB states that, after several years of implementation, Notified Bodies have now accumulated substantial experience with the procedure.
Team-NB Identifies Both Strengths and Weaknesses
The position paper presents a balanced assessment.
On the positive side, Team-NB notes that:
Expert Panels generally respect statutory timelines;
dialogue between Expert Panels and Notified Bodies has improved;
CECP has increased attention to the robustness of clinical evidence.
However, the organisation also identifies persistent challenges, including:
administrative burden;
uncertainty around evidence expectations;
extended certification timelines;
concerns regarding the impact of public negative opinions.
23 Expert Panel Opinions Published by November 2026
Team-NB reports that, as of 1 November 2026, 23 Expert Panel opinions had been published by the European Commission, with additional opinions still awaiting publication following completion of certification.
This growing body of CECP experience provides the basis for the recommendations in the position paper.
Statutory Timelines Are Generally Being Respected
One of the main positive findings relates to procedural timelines.
According to Team-NB, Expert Panels have generally complied with:
the 21-day screening period;
the additional 39-day period where a scientific opinion is required.
Team-NB considers this evidence that the Expert Panel system is capable of operating within the timelines established by the MDR.
Increased Scientific Scrutiny
The organisation also recognises that CECP has increased the degree of scientific scrutiny applied to certain high-risk devices.
Expert Panels provide an additional perspective on the adequacy of clinical evidence submitted in support of certification.
Team-NB acknowledges that this mechanism can strengthen confidence in regulatory decisions and contribute to patient safety.
Improved Dialogue Between Expert Panels and Notified Bodies
Another positive development has been the introduction of greater interaction between Expert Panels and Notified Bodies.
Historically, Notified Bodies would submit their assessment and often receive an Expert Panel opinion only at the end of the process.
More recent practice has included meetings where concerns can be discussed before the final opinion is issued.
Team-NB considers this improved dialogue important for transparency and mutual understanding.
Concern Over Class IIb Active Devices
One of Team-NB’s main criticisms concerns the inclusion of Class IIb active devices intended to administer or remove medicinal products within the scope of Article 54.
The association argues that this category creates a disproportionate burden for manufacturers and Notified Bodies.
Unlike Class III implantable devices, these products may be certified through quality management system certification rather than individual product certificates, which can create additional procedural complexity.
Team-NB Supports Removing This Category from Article 54
Team-NB specifically welcomes MDR revision proposals that would remove these Class IIb active devices from the scope of Article 54.
The association argues that CECP should focus on the highest-risk device categories where additional scientific scrutiny provides the greatest public-health value.
Clinical Evidence Expectations Remain Unclear
A recurring concern identified by Notified Bodies is the lack of predictability around clinical evidence expectations.
Team-NB notes that many Expert Panel opinions conclude that clinical evidence is insufficient but do not always clearly define:
what level of evidence would be acceptable;
which specific evidence gaps are decisive;
the scientific rationale for alternative expectations;
reference benchmarks that could guide future submissions.
This creates uncertainty for both manufacturers and Notified Bodies.
Predictability Is Essential for Clinical Development
Team-NB argues that manufacturers need to understand what constitutes sufficient evidence in order to:
design clinical development strategies;
plan clinical investigations;
support consistent conformity assessment;
reduce regulatory uncertainty.
The association therefore recommends that Expert Panel opinions provide clearer scientific reasoning and more explicit evidentiary expectations.
Public Negative Opinions May Have Unintended Consequences
The paper also addresses the public availability of unfavourable Expert Panel opinions.
According to Team-NB, manufacturers may experience commercial uncertainty when informed that a device will enter CECP, particularly because a negative opinion may be published publicly.
The association does not oppose publication of scientific opinions, but argues that transparency should include the full regulatory context.
Notified Body Justifications Should Also Be Public
Team-NB highlights situations where a Notified Body may ultimately certify a device despite concerns raised by an Expert Panel.
In these cases, the Notified Body may have developed detailed scientific and regulatory justifications explaining:
the clinical evidence considered;
the benefit-risk conclusions reached;
why the Expert Panel concerns did not preclude certification.
However, Team-NB reports difficulties in publishing these explanations alongside the Expert Panel opinion.
Risk of Presenting Only One Side of the Assessment
Where an unfavourable Expert Panel opinion is public but the Notified Body justification is not, stakeholders may see only one side of a complex scientific discussion.
Team-NB therefore argues that both the Expert Panel opinion and the Notified Body’s reasoned justification should be publicly accessible where certification proceeds.
This, according to the association, would support more complete regulatory transparency.
Administrative Burden from Multiple Platforms
The position paper also criticises duplication between EUDAMED and CIRCABC.
Notified Bodies may be required to submit information through both platforms, creating additional administrative work without adding scientific value.
Team-NB recommends greater system integration.
Response Timelines Can Be Too Short
Another operational concern relates to response deadlines.
Team-NB reports that where Expert Panels raise questions, Notified Bodies may have only two to three days to prepare comprehensive responses.
This can be difficult where additional information needs to be obtained from manufacturers or specialist experts.
Meetings May Be Difficult to Organise
The paper also states that meeting notices can be very short and proposed dates may not always be negotiable.
This can create difficulties for Notified Bodies operating across multiple time zones or relying on clinical specialists who also have healthcare responsibilities.
Team-NB calls for more advance notice and greater flexibility.
Written Exchange Could Improve the Process
To address these constraints, Team-NB proposes using an initial written exchange between the Expert Panel and the Notified Body.
Under this approach:
the Expert Panel would submit questions in writing;
the Notified Body would prepare documented responses;
the Panel would review those responses;
a meeting would only be held if unresolved issues remained.
Team-NB argues that this would create a clearer audit trail and make meetings more focused.
Expert Panel Commentary Should Remain Within Scope
The association also raises concerns about Expert Panel opinions commenting on areas beyond clinical evaluation.
Examples cited include:
MRI safety;
sterilisation methods;
animal-derived materials;
engineering design.
Team-NB notes that Expert Panels typically review clinical evaluation documentation rather than the complete technical file.
Clinical Assessment Should Remain the Core Focus
Team-NB therefore recommends that CECP Expert Panel opinions focus on:
clinical evaluation;
clinical evidence;
benefit-risk conclusions;
PMCF.
Technical issues outside the clinical assessment should generally remain within the Notified Body conformity assessment process, using appropriately qualified technical experts.
More MDR-Specific Training Recommended
The position paper also calls for additional training for Expert Panel members.
Team-NB argues that scientific expertise should be complemented by a strong understanding of:
MDR requirements;
clinical evaluation rules;
state-of-the-art principles;
benefit-risk assessment;
conformity assessment practice.
This would help distinguish between mandatory MDR requirements and recommendations for additional evidence.
Has CECP Achieved Its Intended Purpose?
Team-NB’s answer is: “both yes and no.”
The organisation believes CECP has successfully:
created an independent scientific oversight mechanism;
increased scrutiny;
strengthened challenge;
added another safeguard for high-risk devices.
At the same time, it considers the procedure less successful in establishing predictable and harmonised clinical evidence expectations across Europe.
Six Recommendations for MDR Revision
Team-NB proposes six main reforms.
1. Restrict CECP Scope
Team-NB recommends limiting the scope primarily to Class III implantable devices and removing Class IIb active devices intended to administer or remove medicinal products.
2. Clarify Expert Panel Review Scope
The organisation recommends formally defining CECP review as focusing on:
clinical evaluation;
clinical evidence;
benefit-risk assessment related to clinical data;
PMCF plans.
3. Strengthen Engagement
Team-NB calls for more structured exchanges between Notified Bodies and Expert Panels.
Regular interaction could improve understanding of:
common manufacturer deficiencies;
emerging clinical evidence challenges;
practical MDR implementation issues.
4. Enhance Expert Panel Training
Expert Panel members should receive continued MDR-specific training and practical updates on conformity assessment.
5. Improve Publication of Notified Body Justifications
Where certification proceeds despite an unfavourable Expert Panel opinion, Team-NB recommends a clear process for publishing the Notified Body’s reasoned scientific justification.
6. Increase Transparency of Evidence Expectations
Expert Panel opinions should clearly explain:
specific evidence gaps;
scientific reasoning;
expected evidence levels;
examples of acceptable evidence approaches where appropriate.
Team-NB argues that this would improve harmonisation and regulatory predictability across Europe.
Implications for Manufacturers
For manufacturers of high-risk devices, the position paper highlights the importance of anticipating CECP requirements early in the clinical strategy.
Key considerations include:
robust clinical evidence planning;
clear benefit-risk justification;
strong PMCF strategy;
alignment between claims and supporting evidence;
preparation for additional Expert Panel scrutiny.
Greater transparency in future Expert Panel opinions could make this planning more predictable.
Implications for Notified Bodies
For Notified Bodies, Team-NB’s proposals would reduce operational burden and provide a clearer framework for interacting with Expert Panels.
The association particularly emphasises:
better scheduling;
written exchanges before meetings;
clearer division of responsibilities;
reduced duplication between IT platforms;
more transparent publication of certification justifications.
A More Predictable and Proportionate CECP
Team-NB does not call for the removal of Expert Panels or CECP.
Instead, it supports continued use of Article 54 while proposing targeted reforms to make the system:
more predictable;
more transparent;
more proportionate;
more efficient;
more scientifically collaborative.
The association concludes that CECP has delivered meaningful benefits but that greater clarity around evidence expectations, stronger regulatory training, reduced administrative burden and a narrower scope could improve the effectiveness of the procedure while maintaining patient protection.
