Avania

Europe’s new Medical Devices Regulation (MDR) is four times longer than the previous Medical Device Directive, and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them — from pre-clinical through post-market. Many companies are unprepared for this task. Our guest, Dr. Kim van Noort, will walk us through some of the biggest challenges that MDR poses, and tell us how to overcome them.

Europe’s new medical devices regulation (MDR) is four times longer than the previous medical device directive (MDD), and it has raised the bar for clinical evaluations. It’s imperative that manufacturers proactively identify the gaps in their data and take the necessary steps to fill them—from pre-clinical through post-market.

First-in-human (FIH) is a critical milestone for companies pursuing medical device development. Medical device developers often experience great pressure to shorten timelines and get to the clinic. However, it is important to keep certain aspects top of mind to have a successful FIH clinical experience.