Coordinating Research and Evidence for Medical Devices

Period: 2021-2024

Funding institution: European Commission – H2020


Short description: Manufacturers of medical devices need to test their products before being allowed to market them. Specifically, they require clinical data showing their medical device is safe and efficient. In this context, CORE-MD project aims to translate expert scientific and clinical evidence on study designs for evaluating high-risk medical devices into advice for EU regulators. A unique collaboration between medical associations, regulatory agencies, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, will systematically review methodologies for the clinical investigation of high-risk medical devices, recommend how new trial designs can contribute, and advise on methods for aggregating real-world data from medical device registries with experience from clinical practice. The consortium is led by the European Society of Cardiology and the European Federation of National Associations of Orthopaedics and Traumatology, and involves all 33 specialist medical associations that are members of the Biomedical Alliance in Europe.

WISE role:THIR PARTY – Wise Angle is in charge of the operational project management on behalf of the European Society of Cardiology (ESC)