Representing one of the largest medical device markets in the world, the European Union (EU) recently underwent a significant regulatory shift. In 2016, the European 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, focusing on the common provisions found in both regulations, is the first in a three-part series that examines the provisions of each new regulation and the potential impact on the medical device and IVD industry. The second in the series will focus on the provisions specifically related to medical devices in the MDR, and the third will be on the provisions specifically related to in vitro diagnostic medical devices in the IVDR. All three publications are based on the form of the proposed regulations as of December 2016.