The BioMed Alliance is very happy to announce the launch of the EU-funded CORE-MD project, a consortium of stakeholders working together to identify ways to enable the scientific, fair, and systematic evaluation of medical devices. Today, we held the kick-off meeting formally starting the work on the project.
For the first time, BioMed Alliance has been named as a partner in a European project including 22 partners involved in the development, evaluation, approval and certification, clinical use, and monitoring of medical devices. The consortium is led by the European Society of Cardiology (ESC) with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT) and cooperates closely with the BioMed Alliance Taskforce on Regulatory Affairs and Medical Devices. The BioMed Alliance is co-leading Work-Package 4 “Networking” of CORE-MD which objective is to establish methods for networking between notified bodies and regulators with clinical and scientific experts.
The CORE-MD project will last three years and aims at translating expert knowledge into advice for regulatory guidance and building expertise and Regulatory Science in the clinical community. The first steps of the project will be to review the methods used in clinical trials for evaluating high-risk medical devices.