Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.

Related Keywords

, European Union Eu Medical Device Regulation , European Union , Medical Device Regulation , Face Mark , Mdr , Ivdr , Mdcg , Notified Bodies ,