Threats and Opportunities for the Clinical Investigation of High-risk Medical Devices in the Context of the New European Regulations. - Lionel Pazart; Sylvia Pelayo; Thierry Chevallier; Gabriel Gruionu; Philippe Mabo; Yves Bayon; Frédéric Barbot; Thomas Lihoreau; Catherine Roussel; Nicos Maglaveras; Eirini Lekka; Hugo Alexandre Ferreira; et al. (BIODEVICES, 2021)