Discusssion

This talk will focus on the regulation changes specific to CE marking devices as industry moves from the Medical Device Directive (MDD) to the Medical Device Requirements (MDR) planned for implementation in early 2020. A range of topics will be covered including how up-classing of medical devices like cannula affects CE marking and registration, how it impacts manufacturing choices in customization of tubing sets, and how industry can continue to invest in developing products for extracorporeal circulation in an increasingly more stringent regulatory climate.