View of a Notified Body on the MDR Implementation Steps

The medical device regulation was published on May 25, 2017 with a transition period of 3 years till May 26 2020. As described in the regulation a fundamental revision of the current directives was deemed necessary to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation. During this presentation the current status of the implementation of this regulation including the designation and notification process of notified bodies for the new legislation will be presented. Moreover, it will be explained if the main tasks of the regulation will be achieved by the current implementation steps and whether innovation will have a place on the EU Market in the future.