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The New MDR: Is it Really New and Do We Really Need It?

A session by Michael Drues
President, Vascular Sciences

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About this session

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:

  • What are the most significant changes in EU MDR system, i.e., what are the changes that really matter?
  • Why is the EU MDR system changing and why now?
  • What is the root cause(s) i.e., precipitating event(s) leading to these changes?
  • What are changes in substance vs. changes in paperwork?
  • Has the new MDR system been “validated” prior to releasing to the market?
  • Will these changes lead to safer and more effective medical devices in the future? What if they don’t?
  • Why aren’t more people asking these same questions?

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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