EU MDR Hot Takes: Evolution or Overreach?

We can all agree that MDR has not worked out according to plan. I think we can also agree that it has created far more headaches than it has resolved.

Will it be worth it in the end?

Listen in as Karandeep Singh Badwal and I debate the merits of MDD vs MDR and try to decide where this monster of a legislation will take us.

Hosted by Greenlight Guru and moderated by Etienne Nichols.





Keywords: medical devices, notified body, medical device regulatory affairs, medical device regulation, medical device classification, regulatory affairs, regulatory affairs medical devices, regulatory compliance, FDA submission, medical device regulation Europe, FDA 510k submission guidance, European medical device regulation, Europe, EU MDR, MDR