ARTICLE SUMMARY:
Since the EU’s new Medical Device Regulation was introduced in 2017, the new regimen’s challenges have been well documented, and the solution has been repeated extensions of unrealistic deadlines. That approach has not solved the problems. Three regulatory leaders told attendees at the recent Dublin Innovation Summit that the time has come to stop postponing the inevitable and substantively change the law, highlighting several important revisions.
It might seem sudden to be discussing substantively changing a major EU-wide regulation as important to a global industry as the recently enacted Medical Device Regulation (MDR). After all, this new regimen was only enacted in 2017 to replace the previous Medical Device Directive (MDD) following years of debate. However, such major changes would only appear sudden if one overlooks the legion of problems that the MDR has produced in only seven years. The increased complexity, cost, uncertainty, and risk generated by the new rules have generally been responsible, together with an improved US regulatory climate at FDA, with turning the traditional medtech innovation business model on its head. Instead of companies looking to initially introduce innovative technologies in Europe, where they could follow a timely and well-established path to CE mark approval under the old MDD, product companies now look to the US first to avoid the increased cost, clinical requirements, and general uncertainty created in Europe by MDR. As a result, established products are being taken off the market in Europe to avoid recertification requirements and innovative devices are no longer available first for EU clinicians to treat patients.
The solution to addressing the wide range of issues created by MDR, which include 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, has been a series of deadline extensions, none of which appears to have addressed the outstanding issues. Instead, the result has simply been to kick the proverbial can down the road to the point where the last set of extensions pushed the timelines out to near the end of the decade.
In response to this growing cycle of frustration, there are now emerging concerted calls for substantive changes to the MDR. In the following interview taken from a panel discussion at the recent Medtech Strategist Dublin Innovation Summit held in April, a group of regulatory leaders explain the need for changing the recently enacted regulations and propose specific areas they believe would benefit from revised rules. The panelists are leading EU regulatory consultant Bassil Akra, CEO of Akra Team; Marc-Pierre Moll, CEO of BVMed, the German medtech trade organization; and Petra Zoellner, regulatory affairs director of MedTech Europe, the EU device trade association. (This discussion has been edited for length and clarity.)
