The expert panel on medical devices and in-vitro diagnostic devices (EXPAMED) has published a new Opinion in the context of the performance evaluation consultation procedure (PECP) for high-risk IVDs. In the latest Opinion related to a device detecting Hepatitis E virus (HEV) transmission in blood transfusion, the expert panel concluded that:
‘’The evidence provided by the manufacturer was comprehensive, and systematically structured with ease of reference of each document against the relevant clause in Regulation (EU) 2017/746 (IVD Regulation; IVDR). Table 1. “Required Content of the Performance Evaluation Report and Compliance Status” (page 11) documents each of the relevant clauses of the IVDR, a summary of the content of each relevant document and the title and document identification of the related manufacturer’s evidence. In providing the evidence in this manner, each of the requirements of the IVDR could be easily identified and the relevant evidence reviewed. On review of the evidence, all relevant aspects of the IVDR requirements were addressed in a satisfactory manner. The assay under review demonstrated appropriate levels of both clinical and analytical sensitivity and specificity. Sufficient evidence was presented on the robustness of the assay. The sample types included in the instructions for use, along with their storage conditions were validated. Detection of all four known genotypes of HEV was demonstrated. The technology used by the manufacturer is estimated as representing “state of the art” and is commonly used in blood donor screening. No significant innovations are employed by the manufacturer. The assay has been in common use in Europe as a donor screening assay since August 2014 and many peer reviewed papers have been published on its performance in a screening setting and in comparison, with other like assays. It is the opinion of the reviewers that the evidence provided by the manufacturer demonstrates the assay is fit for purpose and complies with the requirements of Regulation (EU) 2017/746.’’ (European Commission, 2021)
Step-by-step process of IVD expert panel expressing its scientific opinion
The procedure goes as follows:
- The notified body consults the IVD expert panel providing the necessary information according to MDCG 2021-22, including the intended purpose and the technology of the device;
- The IVD expert panel (and, when relevant, the IVD sub-group 2021-2) provides its opinion taking into consideration the performance evaluation report of the manufacturer (PER), including the scientific validity report, the analytical performance report, and the clinical performance report;
- The IVD expert panel analyzes specific aspects included in the PER, such as:
- The justification for the approach taken to gather the clinical evidence;
- The literature search methodology, protocol, and report;
- The technology on which the device is based, the device’s intended purpose, and any claims made about its performance or safety;
- Acceptability of clinical evidence (clinical data and performance evaluation results) against state of the art in medicine.
- The IVD expert panel reaches its overall conclusions and recommendations on the performance evaluation report;
- According to Article 106.4 of Regulation (EU) 2017/745, the scientific Opinion of the expert panel needs to take into consideration relevant information provided by stakeholders, including patients’ organizations and healthcare professionals. When such information is available, the experts will summarize it and clarify how it was considered for the final Opinion;
- According to Article 106.12 of Regulation (EU) 2017/745, if the expert panel cannot reach a consensus, its scientific Opinion will be based on the view of the majority of its members. In this case, the final Opinion will mention the divergent positions.
Where applicable, the notified body shall consider the expert panel’s scientific views when making its conformity assessment decision. According to the mechanism for scrutiny of conformity assessments of class D devices specified in Art. 50 of the IVDR, the notified body is required to include a full justification in the notification to the competent authority in the event of divergent views between the notified body and the experts.
You can find the Opinions and more information on Expert Panels in our MDlaw Library.
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