February 7, 2023
By Ken Pilgrim and Evangeline Loh
European regulators have made a treasure trove of information available on expert panels related to the Medical Devices Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746.
The MDR Recital 56 introduced the Clinical Evaluation Consultation Procedure (CECP) requirement, further delineated in Article 54, for expert panels to review the Notified Body clinical evaluation assessment report (CEAR) for Class III implantable devices and Class IIb active device intended to administer and/or remove a medicinal product “ARMP”. The expectation is that “the consultation of expert panels in relation to the clinical evaluation should lead to a harmonised evaluation of high-risk medical devices by sharing expertise on clinical aspects and developing CS on categories of devices that have undergone that consultation process.” Also within the MDR, there is the opportunity for the voluntary use of expert panels (Recital 57, Article 61(2)) for consultation regarding Class III devices and ARMP.
Similarly, the IVDR provided for expert review, plus the addition of EU reference laboratories for specific Class D IVDs (Recital 53, Article 48(6)) through the Performance Evaluation Consultation Procedure (PECP), with a similar lofty objective: “The consultation of expert panels in relation to the performance evaluation should lead to a harmonised evaluation of high-risk in vitro diagnostic medical devices by sharing expertise on performance aspects and developing CS on categories of devices that have undergone that consultation process.” We will not belabor the articles which established the expert panels, though suffice to say these exist in the regulations (Article 106 MDR).
Current status of MDR and IVDR expert panels
There has been a fair amount of development since the publication of the Regulations in 2017. We posted in January 2021 about European Commission (EC) Implementing Decision (EU) 2019/1396 regarding the designation of expert panels as well as the announcement regarding the EC published list of experts. Later in the year, we commented on the availability of the IVDR expert panels. EU regulators and expert panels were prolific in 2022, releasingnumerous documents and decisions.
There are 12 expert panels which we’ve reported on before, and if you review the EC website, the experts in each of the panels are identified with links to their C.V. and Declaration of Interest. Note only one expert panel exists currently for IVDs.
In the interest of completeness, it is not too late for a denizen of the EU with the appropriate credentials to apply for membership on an expert panel (reference materials related to the application process are available).
The EC has advanced the acronym EXPAMED (EC Expert Panels on Medical Devices and In Vitro Diagnostic Devices). Related to this, an extensive EC website exists titled “Practical information for experts.” There are rules of procedure for EXPAMED (document D 3.2, draft version 4, March 2022). This portfolio of materials includes Modules on various topics (PowerPoint slides), and Modules Two through Five include narrative (apparently there is no narration for Module 1, “Legislation & regulatory framework”). Specifically, if you want to understand more background information about these expert panels, Module 3 covers roles and tasks of panels and experts.
EXPAMED reports and updates
The accomplishments of EXPAMED are posted to the EC website. We previously summarized the data from the first annual report (April 2021 to June 2022) about the medical device CECP. Individual assessments are posted by each expert panel to the EC website, and these documents represent significant background information for manufacturers with equivalent or similar devices. The device moniker appears to be redacted, though details related to device description and a summary of available clinical data are included.
The same reporting and update structure exists for IVDs subject to the PECP: the positions of the IVD expert panel are reported. This likewise represents a significant amount of information for manufacturers with equivalent or similar IVD devices.
Expert panels are convening and their corresponding reports are being published. While the majority of notifications related to medical device Class III implantable and ARMP devices are notifications and exempt from the CECP (also described in our regulatory update referenced above), the reports from the expert panels for devices which are deemed to require a scientific opinion are available. The IVD expert panel has now also posted views on 16 PECP cases.
Ken Pilgrim is Manager, Regulatory Affairs and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.