CORE–MD is a European Union Horizon 2020 project, that will run from April 2021 until March 2024. It will review methods for evaluating high-risk medical devices, in order to translate expert evidence into advice for EU regulators and to recommend an appropriate balance between innovation, safety, and clinical effectiveness.
Implementation of the Medical Device Regulation (EU) 2017/745 challenges the medical community to engage with regulators, notified bodies and industry to develop transparent, rigorous and proportionate methods for evaluating the clinical aspects of devices and for monitoring their performance.
The CORE–MD consortium will address this challenge bringing together medical associations, EU regulators, national public health institutes, notified bodies, academic institutions, patients’ groups, and health technology assessment agencies, with participation of manufacturers’ trade associations.
Led by the European Society of Cardiology (ESC) in close partnership with the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), the consortium includes 22 partners involved in the development, evaluation, approval and certification, clinical use, and monitoring of medical devices.
WP5 Project management
WP1 Understanding methods used to generate clinical evidence for high-risk medical devices
WP2 Strengthening evidence for high-risk medical devices: New methods for generating clinical evidence.
WP3 Extracting maximal value from medical device registries and real-world evidence.
WP4 Networking and community building