ARTICLE SUMMARY:
After seven years of unsuccessfully addressing MDR’s challenges through multiple deadline extensions, there is a growing consensus that the answer lies in actually revising the underlying regulations. Erik Vollebregt, who crafted the first comprehensive new MDR initiative, which is being offered by German MEP Peter Liese, provides an in-depth analysis of how the proposed revisions can address the issues currently plaguing the European device industry.
Last month in Market Pathways, we featured a detailed discussion with three European medtech thought leaders, all of whom came to the same conclusion on how to solve the problems the device industry is facing resulting from the EU Medical Device Regulation (MDR). Issuesinclude the increased cost and complexity of additional clinical data requirements, an initial paucity of notified bodies and their accompanying resources, and the repeated postponement of launching the EUDAMED database designed to provide EU-wide uniformity. Instead of resorting to another round of deadline extensions, which has been the approach on multiple occasions since the new regulations were implemented in 2017, there was unanimous agreement that the time has come to focus on the actual problems—the inadequacies in the underlying regulations themselves—that can’t be fixed by once again further delaying deadlines. (See “Stop Kicking the Can: Time to Really Change MDR,” Market Pathways, May 21, 2024.)
That point of view appears to be building momentum not only within the European device industry, where leading trade groups, including MedTech Europe, BVMed (the German medtech trade association), and SNITEM (the French device group), have publicly called for revising MDR and its accompanying diagnostics regimen IVDR (In Vitro Diagnostics Regulation), but also among EU legislators, led by German MEP (member of the European Parliament since 1994) Peter Liese.
