Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery

Brief Summary

Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12/2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required to verify the performance and safety of the device in accordance with its intended use throughout its lifecycle. Consequently, PMCF studies are being planned to demonstrate that medical devices previously granted CE marking under the old practices can be used safely by patients throughout their lifecycle.

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