The survey — which closed in late June and was released yesterday — included 230 responses from medical device organizations with a wide range of sizes, mostly from the E.U. and North America. Only 27% (28% among companies with more than $1 billion in annual revenue) plan to declare full MDR compliance in May.
Nearly half, 46%, plan to leverage the MDR’s transitional provisions to continue selling in the E.U. through 2024 while working on their compliance programs — a move that will create additional work to recertify products and manage inventory.