The new EU Medical Device Regulation (MDR) was published in the Official Journal of the European Union on May 5, 2017, marking the beginning of the transition period for any medical device manufacturer selling devices in Europe.1 This new regulation replaces the Medical Devices Directive and the Active Implantable Medical Devices Directive and includes changes to several critical requirements. Medical device manufacturers will notice that there are updated
requirements for technical files, and specifically for clinical evaluation reports. In this paper, we will cover what a clinical evaluation report is and how the requirements under the new regulation differ from the previous directive.
Health authorities across the United States, Europe, and Asia-Pacific are modernizing guidance frameworks, ...
