On May 5, 2017 the European Union legislator published Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices - the EU-Medical Devices Regulations (MDRs) in the Official Journal of the European Union. The new MDRs provide an entirely new legal framework for the EU medical device sector. The Regulations provide numerous new obligations for manufactures and distributors, incl. parallel importers, as well as Notifies Bodies which will have to adjust internal processes and procedures in order to ensure compliance at the distribution of medical devices.