Report: Most medical device makers not ready to meet E.U. MDR deadline

Only about a fourth of medical device companies plan to be fully compliant with the European Union’s new Medical Device Regulation when it goes into effect on May 26, 2020, according to a new survey from the Regulatory Affairs Professionals Society (RAPS) and KPMG.

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.

More than a third of respondents said they planned to spend more the $5 million to achieve compliance.

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