Description: The manufacturer now has to provide under the MDR a sufficient level of clinical evidence for the safety and performance of the device during its lifetime, the acceptability of the benefit-risk ratio and that the device is State of the Art, which all need a qualified assessment.
The concepts will be explained and how to apply it for legacy devices, software and new devices. Issues will be explained such as how to obtain sufficient clinical evidence if there is not enough clinical data. What is a qualified assessment. Where are the requirements (hidden) in the MDR and how to deal with controversial subjects, such as the maybe the required need by a Notified Body for a practicing physician.
Upon completion, participant will be able to explain what sufficient clinical evidence is.
Upon completion, participant will be able to solves issues with unsufficient clinical data.
Upon completion, participant will be able to understand the differences between the MDD/AIMDD
and the MDR on sufficient clinical evicence and what the impact is for legacy devices.