Clinical Research Directory

Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass

Sponsor: Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

Summary

Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12/2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.

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