CE Marking for Cardiovascular Medical Devices: Your Guide
CE marking is mandatory for marketing your cardiovascular medical devices in the EU market. It demonstrates compliance with EU MDR guidelines. The process of CE marking for cardiovascular medical devices is a rigorous, multi-step pathway. It ensures safety,...
CE Marking for Class Ir Surgical Instruments: Complete Guide
Class Ir surgical instruments require CE marking under the EU MDR. Notably, notified body involvement is limited to reprocessing aspects (cleaning, disinfection, sterilization, maintenance, functional testing). Unlike general Class I devices, manufacturers cannot...
CE Mark Process for SaMD: Your Comprehensive Guide
European Union Medical Device Regulation (EU MDR) broadened the scope for SaMD compared to the old Medical Device Directive (MDD). Many software products previously considered low risk are now moderate or high risk under MDR. Moreover, as per EU MDR, SaMD is treated...