Manufacturers should start initiating strategies now to comply with the new requirements of the amended European Union Medical Device Directive that take effect in March 2010, this Nerac white paper urges. "At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies' profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications as the deadline approaches could bottleneck approvals, with serious implications for sales and profits," write authors Deborah Schenberger, Ph.D., and Marco Bafan, M.S.