Gearoid Kerins

Bottlenecks, Timelines, and Complexity: Overcoming EU MDR Challenges

by Gearoid Kerins
It is now over a year since the new EU Medical Device Regulation (MDR) came into effect. Whether you are an early-stage start-up, a company further advanced in your start-up journey, or an established medical device company, what are the current realities of EU MDR compliance? The fact is, there are challenges that will impact just about every medical device company operating or planning to operate in the EU. Before we get into those challenges, though, a quick recap of where we are. Fast-Approaching Deadlines All new medical devices seeking approval for the European market must now go through the...