Improved clinical investigation and evaluation of high-risk medical devices: the rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)
Authors: Fraser A G , Nelissen R G H H , Kjærsgaard-Andersen P , Szymański P , Melvin T , Piscoi P ,   CORE-MD Investigators, Fraser Alan , Szymański Piotr , Gale Chris , Maggioni Aldo , Zanon Elisabetta , Dimopoulou Christina , Ceccarelli Cinzia , Vairami Polyxeni , Ruszanov Anett , Kjærsgaard-Andersen Per , Nelissen Rob , Ott Adrian , Macintyre Elizabeth , Simulescu Loredana , Meijer Marieke , Koletzko Berthold , Wieczorek Sarah , Hadjipanayis Adamos , Del Torso Stefano , Marang-van de Mheen Perla , Hoogervorst Lotje , Steyerberg Ewout W , De Vries Bas Penning , McCulloch Peter , Landray Martin , Prieto Alhambra Daniel , Smith James , Lubbeke-Wolf Anne , James Stefan , Buccheri Sergio , Byrne Robert , McGovern Laurna , Windecker Stephan , Frenk Andre , Siontis Georgios , Stettler Christoph , Bano Arjola , Bally Lia , Rademakers Frank E , D'hooge Jan , Vedder Anton , Biasin Elisabetta , Kamenjasevic Erik , Schnell-Inderst Petra , Kühne Felicitas , Rolfson Ola , Jakobsson Joel , Tornsö Amanda , Caiani Enrico G , Gianquintieri Lorenzo , Cappiello Cinzia , Matera Maristella , Melvin Tom , MacAleenan Niall , Mahon Ria , Meagher Michèle , McGauran Gearóid , Wejs Møller Thomas , Sonne Holm-Schou Ann-Sofie , Szulc Jan , Geertsma Robert E , van Baal Jantine W P M , Hoebert Joëlle M , Cabaço Susana L F , Laricchiuta Paola , Torre Marina , Boniforti Filippo , Carrani Eugenio , Ceccarelli Stefania , Wild Claudia , Ettinger Sabine , Antonio Blasco Amaro Juan , Carlos Rejón Parrilla Juan , Dobrzynska Agnieszka , Epstein David , Strammiello Valentina , Jarke Hannes , Immonen Kaisa , Schlemmer Françoise , Hoekstra Sabina , Mastroroberto Marianna , Ziskoven Christoph , Hahn Michael , Melikyan Erman , Holborow Richard , Halliday Suzanne , Shiryaev Alexey , Viola Gero , van Vugt Harry 
Published: August 2021

Abstract
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, whereas authorizing the placing on the market of medical devices is decentralized to independent ‘conformity assessment’ organizations 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 (Coordinating 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.