Department of Regulatory Affairs, G. Pulla Reddy College of Pharmacy, Osmania University, Mehdipatnam-500028, Hyderabad, Telangana, India
Medical device regulations have its focal center on translating expert knowledge into advice for EU regulatory guidance, and building expertise in regulatory science in the clinical community, the Coordinating Research and Evidence for Medical Devices (CORE MD) project is here to 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. CORE-MD is a European Union Horizon 2020 project which began in April 2021 and was concluded in March 2024. For the first time ever CORE-MD consortium stands to bring together 33 medical associations, on one platform. The major objective of CORE MD is, developing guidance for evaluation of artificial intelligence. CORE MD includes cardiovascular, and diabetes medical devices, since these exemplify devices are used to reduce mortality and morbidity, the use of real-world evidence in regulatory decision making, evidences from clinical trials on High-risk medical devices, establishment of post approval evidence development schemes, tools to retrieve public information on medical devices and information on the performance of these High-Risk Medical Devices. As a result, the need for more sources to provide clinical evidences for medical devices is required, before they are approved for implantation in patients and to add on the focus, CORE MD project has brought brilliant potential in increasing the use of benefit measures and accelerating surrogate outcomes research which would optimize an implant’s benefit-risk ratio and making CORE-MD an ambitious project with great scope.
Medical Device, CORE MD, Clinical Evaluation, Europe Union, Medical Device Regulation (MDR), CE Mark
