The Business of Eye Innovation - Episode 5
Understanding the MDR and Its Complexities
Join host Kris Morrill, the Founder and President of Medevise with 30 years of experience in the healthcare field, as she speaks to Erik Vollebregt, a Partner at Axon Lawyers who specializes in EU and national legal and regulatory issues relating to medical devices, including eHealth, mHealth, software and protection of personal data. He is an expert in life sciences regulation at EU and Dutch level, with a focus on contracts, regulatory litigation against competent authorities and M&A.
On this episode you’ll discover:
How the transition into Medical Device Regulation (MDR) is going for medical device companies almost 5 years since its adoption in April 2017.
The difficulties medical device companies are facing in understanding the concepts in the MDR and the implications this has on those who have been delaying the conversion of still-outstanding MDD and AIMDD certificates.
The extent to which the MDR emphasizes clinical evaluation and support for clinical evaluation and the importance of companies having proactivity in clinical data for their devices.
How companies, particularly companies coming into the European market today, should manage the Blue Guide incongruency and what the most effective ways of navigating the MDR are.
The implications of three different economic operators in the region and the effects of Brexit, Switzerland’s stance on medical device companies operating in Europe, and the issues with Turkish participation in the union.
Find out more about host Kris Morrill and guest Erik Vollebregt
Connect with Kris Morrill and Erik Vollebregt on LinkedIn