Has the Pandemic Impacted Medtech Regulation?

Once discussions began earlier this year about postponing the European Union’s Medical Device Regulation, it was clear that the COVID-19 pandemic would have an impact on medical device regulation. Even the U.S. FDA felt like a different agency, as it demonstrated its own agility through emergency guidance and Emergency Use Authorizations (EUAs). FDA has since rescinded a few such authorizations (and has even been criticized for one) so it seems as though regulatory oversight is unfolding in real-time, based on real-world data.