EU MDR: How To Prepare for The Upcoming Changes In Regulation

Recognizing the need to enforce heightened safety measures and risk management processes, the European Parliament and the Council of the European Union developed the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in 2017. Under the new regulations, medical devices and in vitro devices must receive a CE Marking (symbol for European conformity to regulations established by the European Commission [EC], European Parliament [EP] and European Union [EU] member states) certificate by the set deadlines. To learn more about the EU MDR, download the full paper.