Medical Device Regulation and IVD Regulation
The final texts of the new European Medical Devices Regulation (MDR) and IVD Regulation (IVDR) have been published in the Official Journal of the European Union. Entry into force commenced on May 25th 2017, marking the start of the transition period for manufacturers selling medical devices into Europe. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. The IVDR, which replaces the IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.