ARTICLE SUMMARY:
There finally seems to be an impetus for revising the MDR/IVDR among the EU’s legislative and regulatory bodies, according to MedTech Europe’s senior officials Oliver Bisazza and Petra Zoellner. They expect the process to take a few years but think that this time it might actually happen.
To our loyal readers, we forgive you if the theme of this article has a déjà vu feel to it, causing you to think you’ve heard this song before. To that we can only respond that we feel the same way in reporting on what seems to be well-trodden ground.
It seems that the one constant since the EU implemented the new Medical Device Regulation (MDR) and In Vitro Device Regulation (IVDR) in 2017 to replace the previous Medical Device Directive (MDD) is that there has been an underlying growing view among the entire medtech ecosystem, including product companies, notified bodies, and investors, that the new rules were hurting medical device innovation in Europe and needed to be changed. Those sentiments played out in the dramatic shift that has occurred in the marketplace from the EU being the first commercialization choice for innovative start-ups because they could count on a transparent, timely, and relatively efficient/less costly CE mark approval process (aided by concurrent challenges at FDA) to the new reality where companies now see an improved US climate at FDA (current staffing issues notwithstanding) and chaos, uncertainty, and increased costs in Europe. This has flipped the switch with companies now actively looking to commercialize in the US first. The result has been a slowing of innovation in Europe with patients and clinicians being denied the early access they previously enjoyed to the latest technologies.
After eight years of the industry clamoring for MDR/IVDR changes, the actual revisions have been limited to a series of stops and starts, mostly taking the form of extending deadlines. Oliver Bisazza, CEO of MedTech Europe, the EU’s device trade association, and Petra Zoellner, the group’s director of regulatory affairs, believe the situation has now turned the corner from simply debating the need to revise the regulations to actually gaining consensus among the EU’s tripartite legislative/regulatory structure (comprising the EU Council, Commission, and Parliament), reaching the point where concrete changes seem likely to be in the offing.
