Improved methods for clinical investigation and evaluation of high-risk medical devices

Translating expert knowledge into advice for EU regulatory guidance, and building expertise in regulatory science in the clinical community

CORE-MD is a European Union Horizon 2020 project that will run for 3 years from April 2021. It will review methodologies for the clinical evaluation of high-risk medical devices and recommend new designs to set an appropriate balance between innovation, safety, and clinical effectiveness.

The CORE–MD consortium brings 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.