New Rules for Medical Devices and In Vitro Diagnostic Medical Devices in Europe

    View Authors June 2016

    On May 25, 2016, the European Union (EU) agreed on the new rules that will govern the placing on the European market of medical devices and in vitro diagnostic medical devices. Medical devices and in vitro diagnostic medical devices cover a wide range of products, from adhesive bandages to hip replacements, and from pregnancy tests to HIV tests.

    These provisions will go into the final version of the long-awaited EU medical device and in vitro diagnostic (IVD) regulations, paving a way for a final adoption by the end of 2016.

    This is a significant milestone in a legislative dossier that started back in 2012, with the aim to fill the regulatory gaps uncovered as technology evolved faster than the current regulatory regime, which had not been updated since 2007.