Expert panel opinions on clinical evaluations: procedure and synthesis of consultations

[article first published on 6 july 2021]

The “Clinical Evaluation Consultation Procedure (CECP) for Certain DMs” is an additional requirement for clinical evaluations of implantable and IIb DM IIIs delivering/withdrawing a medicinal product, according to Article 54 of Regulation (EU) 2017/745.

This article explains the procedure for consultation, details the content of an opinion, and summarizes published opinion. It is updated when new publications are made.

Expert group consultation procedure

Below is a reminder of the regulatory process, repeated ad-libitum:

1. The manufacturer produces a clinical evaluation report
2. The notified body of the manufacturer produces an evaluation of the clinical evaluation report (per MDCG 2020-13)
3. The European Expert Group:
   1. Assesses the need to produce an opinion (“screening” stage, by the “Preliminary Review” expert group)
   2. When appropriate: produced an opinion on the NB report (“opinion” step, by the expert group most appropriate for the MD being evaluated)
4. The notified body shall take into account the opinion of the expert panel
5. The manufacturer takes into account that the NB takes into account the opinion of the expert panel

An aid for your clinical evaluations

It can be important, even critical, to take into account published opinions, even if they don’t directly relate to your products. This is all the more necessary :

• If you are subject to the panel consultation process, to understand their expectations and angles of approach
• If you are equivalent to the target device: to benefit from the state of the art study included in the report (publications and issues in the field)
• (If you are not too confident in your NB)

👉 In general, these opinions provide a better understanding of the purposes of clinical studies.

Content of an expert panel opinion

The following §s outline an opinion

Part 1: Decision of the screening experts

Here, the need to produce an opinion is evaluated  according to 3 criteria:

1. Novelty of device and/or of related clinical procedure and associated risks;
2. Health concerns identified in the literature;
3. Significant increase of serious incident (relevant for the assessment).

Summary of selection

• Date of decision
• If applicable: summary of reasons if the information is deemed insufficient to reach a decision.
• Summary of reasons for producing an opinion. This may be motivated by relative uncertainties:
  • to the intended use
  • to the performance of the device
  • to the quality of the clinical data, including:
    • duration of studies
    • completeness, relative to indications for use
• Other comments: this is to elaborate on the reasons that confirmed/infirmed the need for opinion.

The three selection criteria

Criterion 1: Novelty and clinical impact

Novelty may relate to the devices and/or the associated procedure for use.

• Description of novelty:
  • indications for use
  • procedures for uses
  • principle of operation
  • physical composition
  • manufacturing process
  • ..
• Level of Novelty:
  • ⭐⭐⭐High
  • ⭐⭐Medium
  • ⭐Low
• Incertainties related to novelty, e.g., long-term clinical validity
• Possible negative health impacts associated with novelty
• Severity of negative impacts, on 4 levels:
  • ⭐⭐⭐Major
  • ⭐⭐Moderate
  • ⭐Minor
  • None
• Incertainties related to clinical impact, e.g., uncertainties about duration, clinical protocol, indications …

Criterion 2: Health concerns

Or, in the long version, “Scientifically valid health concerns leading to significantly adverse changes in the benefit/risk profile.”

• Bibliography : the list of publications used for making an opinion
• MD group/category: presumably according to the EMDN nomenclature
• Source of health concerns: likely to relate to
  • components;
  • the materials;
  • health impact in the event of device failure;
• Description of concerns and health impact
• Quality and relevance of data used
• Summary

Criterion 3: Significant increase of serious incidents

• Relevance of the data
• Summary of information used

Selection of the expert panel

If applicable, an experts panel is selected to formulate an opinion, from the ten existing panels.

Part 2: Expert panel opinion

Summary

👉 Status opinion on the adequacy of the study, caution: the opinion is very clear-cut, it will quickly be unfavorable if there are too many risks or uncertainties in the case.

• Device description: identification and medical indications
• Novelty of the device: identification and degree of novelty
• Evaluation assessment: type of clinical evaluation (new data, literature); adequacy of study (duration, indication, relevance of equivalence…); adequacy of planned PMCF
• Adaptation of clinical evidence: identification of clinical data gaps, related to both risks and benefits, based on intended uses
• Estimation of B/R: judges whether conclusions about B/R are admissible, given the above
• Clinical evidence vs. medical indications: status if evidence is sufficient, based on indications
• Planning for PMCF: assesses whether the PMCF plan is appropriate
• Conclusions and recommendations: if applicable, lists advice for resuming clinical assessment, phrased in the conditional tense but to be taken in the imperative

Details

This is where the NB assessment is really critiqued, according to five criteria:

1. An opinion on the NB’s assessment of the adequacy of the manufacturer’s clinical evaluation report.
2. Advice on the NB’s assessment of the sufficiency of the clinical evidence provided by the manufacturer.
3. Advice on the NB’s assessment of the adequacy of the manufacturer’s determination of the benefit/risk ratio.
4. Advice on the NB’s assessment of the consistency of the manufacturer’s clinical evidence with the intended purpose, including the medical indication(s)
5. Notice on the NB’s assessment of the consistency of the manufacturer’s clinical evidence with the PMCF plan.

👉 Note that the list of publications used to forge the opinion is provided.

General conclusions and recommendations

A summary of the expert panel’s opinion, you may want to start with this summary to get an idea of the opinion.

Divergences in the expert panel

Where applicable, differences among the experts are explained.

List of published opinions

The table below provides a synthesis of published opinions, a link is provided to each of the reports.

Source : List of opinions provided under the CECP