Note, this presentation will be a pre-recorded version
There is much reportedly changing in the EU medical device regulatory system but why is the system changing and is the system really changing or is this another example of the more things change the more they remain the same? Ironically, medical devices are required to be tested and validated prior to market. Should not the same apply to new regulation, i.e., the EU “new” MDR system?
In this presentation, Dr. Drues discusses the most significant changes in the EU Medical Device Regulation (MDR) system, why these changes are being made, and most importantly provides a critical analysis of whether or not these changes will likely do any good – a question few in this industry seem to be asking. Questions to be discussed include:
Simply put: years from now, will these changes lead to safer and more effective medical devices in the future? What if they don’t? And if we don’t see fewer problems with medical devices in the future, aren’t all these changes just a colossal waste of time and money?
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