EU medical device and diagnostic regulatory overhaul: Key changes and their impact

On May 26th 2017, a new set of European Medical Device Regulations (“MDR”) and In Vitro Diagnostic Regulations (“IVDR”) entered into force. They represent a major overhaul and tightening of the previous directives and affect all companies marketing or developing devices and/or diagnostics under their name or trademark in the EU (termed ‘manufacturers’ in the regulations). The changes introduce a standardised regulatory framework for the EU that aims to be robust, transparent, and to overcome differences in interpretation and weaknesses brought to light in recent safety scandals.