The EU Medical Device Regulation (MDR) came into force on 26 May 2021. At the same time as the implementation of the Medical Devices Regulation, the EU project CoreMD started, which - funded within the framework of Horizon2020 - will develop methodological support for regulators to accompany the MDR/IVDR. Led by the European Society of Cardiology (ESC) and the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), the consortium includes 22 partner institutions involved in the development, evaluation, authorisation and clinical use as well as surveillance of medical devices: National regulators, Notified Bodies, medical associations, clinical trial centres, patient advocacy and HTA institutions. The project start coincides with the new EU regulations for medical devices, according to which the requirements for clinical evidence for high-risk medical devices are increased, but these have not yet been specified with regard to study designs, endpoints, etc.
The three-year project began with a systematic review of the methods used in clinical trials to evaluate high-risk medical devices, including statistical methods and the utility of patient-reported outcomes for regulatory decision-making. Moreover, CoreMD will look at how to generate evidence using innovative methods such as randomised registries and how to evaluate artificial intelligence algorithms built into medical devices. At the end of the project, medical device regulators, in particular the European Commission's Working Group on Clinical Investigation and Evaluation (CIE) and the working groups of the Medical Device Coordination Group (MDCG) will be supported with methodological guidelines for product specifications.
The Austrian Institute for Health Technology Assessment (AIHTA) is leading the work package "Networking and Community Building" in CORE-MD and will - together with Team NB (European Association of Notified Bodies) - develop a training compendium for staff of Notified Bodies, clinical investigations by clinicians, etc.