CEO presentation on Adverse Events handling under the MDR (2017/745) |

With the change from MDD to MDR Adverse Event (AE) reporting in Medical Device Clinical Trials is supposed to be clearer and more uniform, but is it? There has not been a topic that I have been discussing more than that leaving me to conclude that at this moment the answer is no due for several reasons. The main ones being that EUDAMED is not ready for it and that the MDR focusses on reporting to the Competent Authorities not the Ethics Committees, leading to different reporting requirements for the different EU countries and regulatory bodies involved in Clinical Trials. So regardless MDR directions, it is key to check AE reporting needs with every regulatory body involved at the start of your Medical Device Clinical Trial to make sure you are compliant with the applicable requirements.