Clinical investigations of medical devices and the impact of regulation (EU) 2017/745 ; Les investigations cliniques de dispositifs médicaux et l’impact du règlement (UE) 2017/745

Medical devices are an essential component of healthcare. They are developing at an ever-increasing pace, with ever-greater innovation. Prior to 2021, they were regulated by European directives requiring transposition into national lay, which generated a lack of harmonization between countries. The entry into force of Regulation (EU) 2017/745 on May 26, 2021 marks a turning point in the regulatory landscape. The objectives pursued are multiple: to support innovation, guarantee the proper functioning of the internal market and ensure a high level of protection for human health and safety. In particular, the regulation strengthens requirements for clinical investigations. These will become the rule for demonstrating the safety and performance of a medical device, both before and after it is placed on the market. This regulatory change is having a major impact on manufacturers, most of whom are small and medium-sized companies, who must comply with Regulation (EU) 2017/745 to maintain the CE marking of their medical devices already on the market. These companies sometimes find themselves forced to merge with others or stop certain product ranges. Some guides, fact sheets and webinars are offered to manufacturers to help them apply the new regulation. Despite this, after 2 years, difficulties persist for all actors, and a vote has been taken in March 2023 to extend the transition period and avoid an economic and health catastrophe. ; Les dispositifs médicaux sont une composante essentielle des soins. Leur développement est de plus en plus rapide et l’innovation toujours plus grande. Avant 2021, ils étaient réglementés par des directives européennes nécessitant une transposition en droit national ce qui générait un manque d’harmonisation entre les pays. L’entrée en application du Règlement (UE) 2017/745, le 26 mai 2021, marque un tournant dans le paysage réglementaire. Les objectifs poursuivis sont multiples : soutenir l’innovation, garantir le bon fonctionnement du marché intérieur et assurer un niveau élevé de ...