The European Commission has published its long-awaited proposal for a regulation amending and simplifying the EU Medical Devices Regulation (EU MDR) and the In Vitro Diagnostic Medical Devices ...

Complex approval processes and high cost are among the challenges causing US medical device manufacturers to question whether the European Union Medical Device Regulations (EU MDR) are worth the time, ...

Linda Horton says changes won't affect U.S. companies much. Although changes to the European Union's Medical Devices Directives probably won't involve a major overhaul of the regulations or the system ...