Info 26 May 2021 by eub2 -- last modified 26 May 2021 As of 26 May, new EU rules on medical devices (MDR) enter into application, establishing a modern and more robust regulatory framework to protect public health and patient safety. Advertisement 1. Why is there a need for new rules on medical devices? The EU rules on the safety and performance of medical devices were created in the 1990s. To reflect the substantial technological and scientific progress in this sector over the last 20 years, the Commission has proposed to update the rules to improve the safety of medical devices, with a view to modernise the sector and to consolidate