Healthcare professionals need to maintain their knowledge and skills to deliver the best possible care to patients. Medical societies play an important role as providers of continuing medical education (CME) and have actively continued this role during the COVID-19 pandemic adapting the delivery of education to virtual meetings and courses. The Biomedical Alliance in Europe CME Experts Committee conducted two surveys to collect information on the delivery of CME, generally, and during the COVID-19 pandemic from the member medical societies. In this article, we will present the most relevant data collected and share some reflections based on this analysis.

In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, while authorising the placing on the market of medical devices is decentralised to independent ‘conformity asssessment’ organisations called notified bodies. The first legal basis for an EU system of evaluating medical devices and approving their market access was the medical device directives, from the 1990s. Uncertainties about clinical evidence requirements, among other reasons, led to the EU Medical Device Regulation (2017/745) that has applied since May 2021. It provides general principles for clinical investigations but few methodological details ‒ which challenges responsible authorities to set appropriate balances between regulation and innovation, pre- and post-market studies, and clinical trials and real-world evidence. Scientific experts should advise on methods and standards for assessing and approving new high-risk devices, and safety, efficacy, and transparency of evidence should be paramount. The European Commission recently awarded a Horizon 2020 grant to a consortium led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, that will review methodologies of clinical investigations, advise on study designs, and develop recommendations for aggregating clinical data from registries and other real-world sources. The CORE‒MD project (Coordination of Research and Evidence for Medical Devices) will run until March 2024; here we describe how it may contribute to the development of regulatory science in Europe.

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