Clinical Evaluation Reports Under the New EU MDR



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.

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