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 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.
This Zenodo community contains research outputs derived from scientific research done by the CORE–MD consortium.
Guidelines:
- Only staff and researchers affiliated with a partner involved in CORE-MD can submit their data for deposition in this community.
- Research (journal) articles, reports and preprints can also be submitted to this community.
- Code/Software can be submitted to this community
Disclaimer
Data submitters are solely responsible for the quality and content of the submitted data files to the CORE-MD Zenodo Community.