ARTICLE SUMMARY:
Unrelated to, but concurrent with the MDR challenges facing the EU are potentially equally difficult situations confronting Britain’s and Switzerland’s device industries. While the causes of the two nations’ problems are unconnected, they have one thing in common: both have global impact. Here experts from each country—Claire Dyson and Pedro Eerdmans—explain the two situations and offer recommendations on how companies should respond.
As if the added complexity, cost, and ever-changing timelines for implementing Europe’s new Medical Device Regulation (MDR) weren’t enough–most notable being the recently adopted extensions that prolong the process until the end of this decade depending on device risk classification—the United Kingdom and Switzerland at the same time are going through their own medtech regulatory crises, unrelated to each other and to MDR. One potential common thread: both countries have raised the possibility of applying US FDA standards for accessing their respective markets, thereby keeping alive the long-discussed faint hope of moving toward global regulatory harmonization. (See “Switzerland and the UK: Regulating Outside of MDR,” Market Pathways, March 15, 2022.)
In this interview, we have brought together experts on the device regulatory regimens of both countries who also have industry experience to explain the current situations and offer suggestions as to how device companies can best continue to operate under these new rules. Claire Dyson is a British medical device consultant and former head of the UK Approved Body DEKRA. Pedro Eerdmans, MD, PhD, who lives in Switzerland, is director of global strategy services for the consulting firm NAMSA and also previously worked with DEKRA. (Both are pictured above.)
