Impact of changes under the new EU Medical Devices Regulation (EU) 2017/745 to international registrations

Regulation (EU) 2017/745 on medical devices (MDR) introduces a major update of the regulatory framework in the European Union (EU). This modernisation of the European regulatory system brings about several changes to the information provided with the devices and their regulatory documentation.

This document analyses the changes to the regulatory documentation due to the MDR that might be relevant for product registrations outside of EU/EEA. It is addressed to economic operators, and to regulators who are based outside of EU/EEA.