The introduction of the new Regulations on medical devices in the European Union meant stricter controls and reinforced rules on transparency and clinical evidence. The scientific bodies involved in the conformity assessments (apart from Notified Bodies) are Expert panels and EU Reference Laboratories (EURLs) for IVD devices. While the EURLs have not yet been set up, the European Commission already appointed an official list of individuals to serve on expert panels.
The role of the expert panels
The role of the expert panels is to support and advice the scientific assessment of medical devices and IVDs. Depending on needs, their tasks include:
· providing an opinion on the notified bodies’ assessments of clinical evaluation and the performance evaluation of certain high-risk IVDs and medical devices;
· providing advice to the Medical Device Coordination Group (MDCG) and the European Commission on safety and performance of IVDs and medical devices;
· providing advice to manufacturers on their clinical developments and investigations;
· providing opinions as results of consultations as well as technical and scientific advice to EU countries, manufacturers, and notified bodies;
· contributing to developing and maintaining relevant documents.
The panel members and their expertise fields
In consultation with the Medical Device Coordination Group (MDCG), the European Commission selects the members according to their scientific, clinical, and technical expertise. The members are essentially experts in their own field who fulfil the following mandatory requirements: EU, EFTA, or Turkish citizenship, a university degree in a medical or scientific subject, at least 10 years of professional experience, and good knowledge of English language. Moreover, the members cannot have any financial or other interests which could influence their impartial work.
Currently, the Expert Panels count more than 200 experts across 12 different panels. They cover a wide range of medical fields, e.g., neurology, ophthalmology, and in vitro diagnostics. Some panels have further sub-groups, for instance, if they address specific technologies. During the first year of operation, the Panels have issued 18 scientific opinions on clinical and performance evaluation assessments of high-risk devices and in vitro diagnostics. Opinions are relevant for manufacturers as they provide advice concerning manufacturer’s intended clinical development strategy and proposals for clinical investigation (European Commission, 2022).
The members of the Panels from all fields can be found here, while the MDlaw article reports the 12 areas of expertise as well as further information on the topic. One of previous MDlaw article also presents the process and impact of the first opinion released for Class III implantable medical devices.
Handover of medical devices’ panels to EMA
On March 1, 2022, the Commission’s Joint Research Centre (JRC) handed over the panels on medical devices and in vitro diagnostic medical devices to the European Medicines Agency (EMA). This is a result of the extended mandate of EMA, developed during the COVID-19 pandemic, on crisis preparedness and management of medicinal products and medical devices. This is one of the various steps taken by the EU to improve its resilience in emergencies and prevent market disruptions.
Simona Varrella
Expert Consultant, Publications department
11.03.2022
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References:
European Commission. (2022). Medical Devices – Expert Panels. Overview. Retrieved on 11/03/2022 from https://ec.europa.eu/health/medical-devices-expert-panels/overview_en.
European Commission. (2022). Medical Devices – Expert Panels. Expert. Expert panels. Retrieved on 11/03/2022 from https://ec.europa.eu/health/medical-devices-expert-panels/experts/expert-panels_en.
Joint Research Centre. (2022). Handover of expert panels on medical devices and in vitro diagnostics from the Commission’s Joint Research Centre (JRC) to the European Medicines Agency (EMA). Retrieved on 11/03/2022 from https://joint-research-centre.ec.europa.eu/jrc-news/jrc-hands-over-expert-panels-ema-2022-03-03_en.