The requirements for placing medical devices on the market in Europe have been strengthened through European regulations (MDR 2017/745 & 2017/746). Following those regulations, evidence generation is now a cornerstone during the entire development life cycle for the devices to meet safety and performance requirements for market access and to fulfill post-market responsibilities. A methodological approach to define, determine and update the state of the art for different device technologies is needed. Registries and other sources of real-world data for demonstration of regulatory compliance both pre- and post-market can be used. Relevant quantitative and qualitative methodologies for integrating evidence derived from various data sources in the preclinical and clinical evaluation are now essential. Additionally, a particular attention must be paid to highly innovative devices, to high-risk devices or to digital devices, bearing in mind that regulations in relation to artificial intelligence are currently evolving. Furthermore, beyond methodological issues, challenging regulatory issues also concern the need to increase the number of regulatory affairs profiles, relieve the workload of notified bodies and support companies in upgrading their certificates.
Hence, we welcome scientific communications on research encompassing any of the mentioned aspects.