Representing one of the largest medical device markets in the world, the European Union (EU) recently underwent a significant regulatory shift. In 2016, the EU Council, Parliament and Commission agreed on final regulatory texts that will govern medical devices and in vitro diagnostic medical devices (IVD), reportedly beginning in 2020. The proposed regulations, the Medical Devices Regulation (MDR) and the in vitro Diagnostic Medical Devices Regulation (IVDR), are designed to fill the regulatory gaps uncovered as technology outpaced the current regulatory regime, which was last updated in 2007. This new regulatory order, reportedly scheduled to be published in the Official Journal of the European Union in the spring of 2017 and to become fully effective three to five years later, ushers in a new regulatory era for medical device and IVD manufacturers throughout the world.
This publication is the final installment in our series examining the new regulations governing Medical Devices and in vitro Diagnostic Medical Devices. Focusing on the IVDR, this publication examines it and focuses on the IVD-specific provisions therein regarding classification, performance evaluations and clinical data, and conformity assessments.