ARTICLE SUMMARY:
Believing that the MDR and IVDR have not delivered on their original promise, a white paper from the German device and diagnostics industries explains how the new rules have fallen short and what can be done to address these concerns. Erik Vollebregt, the author of the report, highlights five key areas.
Germany is the third largest medical device market in the world, behind the US and Japan, and by far the largest in Europe, twice the size of France and three times as large as the UK, Spain and Italy. Befitting its size, the German device industry has been a leading voice in the regulatory changes that have transpired since the initial implementation of the new Medical Device Regulation (MDR) and its diagnostics counterpart, the In Vitro Diagnostics Regulation (IVDR) in 2017, largely through its respective trade associations, BVMed, the German device trade group, and VDGH, that country’s diagnostics organization. They were among the leaders in calling for the post-pandemic deadline extensions for MDR re-certification of products until May, 2024 (based on the March 2023 amendments), and even later this decade for diagnostics on a tiered-deadline basis according to risk levels (based on the January 2022 amendment).
These two groups recently commissioned Erik Vollebregt, an expert on medtech regulatory law with the Netherlands’ Axon Lawyers, to draft a white paper explaining their key areas of concern with the current MDR and IVDR, and laying out general ways in which these issues could be addressed. This interview with Vollebregt summarizes the device and diagnostics communities concerns with the current regulatory regimen, and while the report purposely avoided offering specific, fixed solutions to these challenges, the white paper takes the approach of outlining important areas that need revising and offering general suggestions in the hope that this can start a dialogue among industry, regulators and legislators with a goal of developing specific solutions, rather than simply further extending the regulatory timelines as has been the past practice.
