EU "two-stage" device approval system could grow out of current challenges -- Quintiles/MTC consultant.
This article was originally published in The Gray Sheet
Executive Summary
EUROPEAN "TWO-STAGE" DEVICE APPROVAL SYSTEM WITH ADDITIONAL REQUIREMENTS for critical products may emerge out of challenges facing the existing system, Mika Reinikainen, consulting director at Quintiles Medical Technology Consultants, said at a recent Regulatory Affairs Professionals Society meeting in Washington, D.C. "We may end up having a two-stage system" under which "for critical products there may be something additional" once the CE mark is obtained.