How CEOs and Investors Are Adapting to MDR

The recent decisions by European legislators and regulators to extend the implementation timelines for the Medical Device Regulation (MDR) to the end of the decade depending on product risk classification adds yet another level of complexity to what has been an ever-changing regulatory regimen since the new rules were first adopted in 2017. Will this extension obviate the bottleneck that many in the industry feared would occur at under-resourced notified bodies or will it simply be an excuse for companies to kick the can down the road and simply postpone the eventual logjam? And taking a more macro view, what will MDR do to the overall innovation ecosystem in Europe that has brought the world so many of the major device advances throughout the industry’s history? Will entrepreneurs and investors abandon Europe for the more favorable regulatory climate of the US and even parts of Asia, taking their start-ups with them, and what will that mean for European patients and clinicians, who once had early access to innovative devices, but who may now be among the last to receive such therapies?

The following excerpts from a recent panel at Medtech Strategist’s annual Dublin Innovation Summit address those and other important questions concerning the impact of MDR. The panelists were an experienced group of investors and device company CEOs, some of whom wear both of those hats: John O’Dea, CEO of Palliare (insufflation technology for laparoscopic robotic endoscopic surgery); Florian Ludwig, CEO of CardiacBooster (ventricular assist device) and a venture partner with Thuja Capital; James Eadie, managing partner with Santé Ventures; and Bernard Collins, who is an investor and chairman of Aerogen and a board member of several device firms, having spent many years with Boston Scientific. (This article has been edited for clarity and length.)