More than 50% of high-risk implantable devices in Europe are used in cardiology and orthopaedics – such as heart valves and hip prostheses – and the Horizon 2020 CORE-MD (Coordinating Research and Evidence for Medical Devices) project, starting today, aims to evaluate the methodologies used to establish the existence of sufficient clinical evidence to approve and certify such medical devices.

CORE-MD will propose how to generate new clinical evidence using innovative methodologies, for example randomized clinical registry studies, and how artificial intelligence algorithms qualified as medical devices should be evaluated, in addition to statistical evaluations and the use of patient-reported outcomes. The resulting recommendations will be submitted to the European Commission's Clinical Research and Evaluation Working Group, so that they can be considered as a basis for developing new documents to support current legislation.

Politecnico di Milano is part of the consortium with the research group of Prof. Enrico Caiani (Dipartimento di Elettronica, Informazione e Bioingegneria), who states: “I am convinced that this project will provide knowledge and useful methodologies to improve the level of transparency, safety and reliability of the new high-risk medical devices that will come onto the market in the next few years, for the benefit of all of us as citizens and potential 'future patients'”.

The kick-off of the three-year project takes place close to the coming into force of the new European Regulation for Medical Devices (May 26, 2021), which will increase the requirements needed to demonstrate clinical evidence for high-risk medical devices.

CORE-MD brings together a consortium of 22 European partners led by the European Society of Cardiology (ESC) in collaboration with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT).

For more information: www.core-md.eu