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International In Brief

This article was originally published in The Gray Sheet

Executive Summary

EU upclassifications: An initiative to bump hip, knee and shoulder replacements in Europe from Class IIb to the higher-risk Class III may serve as a model for reclassifications down the road, said Ibim Tariah of BSI Management Systems at the Sept. 28-29 AdvaMed 2005 International Conference in Washington, D.C. (1"The Gray Sheet" Sept. 9, 2005, p. 9). Tariah suggested that a breast implant upclassification in 2003 was "a test case" involving a relatively small number of manufacturers. By contrast, the pending orthopedic reclassification affects "some of the big medical device companies of the world, and there's no doubt about it [that] it's going to pose a much greater challenge...and will possibly be the gold standard that could be used should a situation like this arise in the future," Tariah said...

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