Class B medical device CE certification signifies that a medical device has been evaluated and found compliant with the European Union Medical Device Regulation (MDR) 2017/745. This certification indicates that the device meets essential safety and performance requirements set by the EU, ensuring it can be marketed and sold within the European Economic Area (EEA). For Class B devices, which are considered moderate-risk, the certification process involves a comprehensive assessment of the device's design, manufacturing processes, and clinical data by a Notified Body. The CE mark affixed to the device confirms its adherence to EU regulations and facilitates its acceptance across EU member states.