The final texts of the greatly anticipated European Medical Devices Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) have just been published in the Official Journal of the European Union. The Regulations will enter into force on May 26th signalling the transition for manufacturers selling medical devices and in vitro diagnostics in Europe. If you would like assistance in managing the transition or to understand how the new regulations will affect your business please contact Stuart Hendry Alacrita’s Medtech partner.