ARTICLE SUMMARY:
The EU’s medical device and diagnostics trade association believes that the time is past for addressing the problems with MDR and IVDR through simply extending regulatory timelines. In this interview, MedTech Europe’s leaders explain why it issued a position paper asserting that significant structural reform is needed to get the system back on the right track.
MedTech Europe, the EU’s device and diagnostics trade association, has supported the new MDR and IVDR since the new rules became effective in 2017, believing their objectives worthwhile and warranting the changes being implemented in the regulatory system.(See “MDR Changes Ahead: An Interview With MedTech Europe’s Oliver Bisazza,” Market Pathways, October 27, 2022.)Among those goals, according to the regulations themselves, were establishing a “transparent, predictable and sustainable regulatory framework” for both devices and diagnostics. Unfortunately, in the eyes of the association, those goals can no longer be accomplished through simply providing companies with more time to comply with the new re-certification rules by extending the timelines. In its view, the time has come for significant structural reform if the system is to be able to achieve those original goals.
Those structural reforms are outlined in a recent MedTech Europe position paper, which CEO Oliver Bisazza, and Petra Zoellner, director of MDR/IVDR, highlight in this interview. The group’s proposed reforms address three key areas: efficiency, innovation, and governance, while maintaining high levels of safety and performance. Specifically, MedTech Europe recommends developing a more efficient and resource-effective CE marking system, with particular emphasis on improving predictability, reducing administrative burden, and being flexible enough to adapt to ongoing market changes.
Bisazza and Zoellner also emphasize the need for the EU system to return to a level where it is once again hospitable to innovation, as it was pre-MDR when companies with innovative technologies looked to launch them in Europe first into what was then seen as a welcoming regulatory climate that was much more predictable, transparent, and faster than the FDA. Since then, however, the climates have reversed.
A final key area covered in the position paper emphasizes the need for an accountable governance structure. MedTech Europe executives suggest that the EU establish a single, dedicated structure to oversee and manage the regulatory system that would have, among other powers, the authority to designate and oversee notified bodies and make system-level decisions that now are delegated on a national level.
As with their counterparts at BVMed and VDGH in their respective white paper, MedTech Europe’s position paper is not so much intended to provide specific regulatory and legislative corrective language. The goal of the paper is to outline the problems with the current regulations and begin a dialogue with the relevant regulators and legislators aimed at crafting and implementing effective solutions, as opposed to simply kicking the can down the road by extending existing timelines as has been the favored course of action up until now. (This interview has been edited for length and clarity.)
