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Ortho Firms Should Begin Strategizing For EU Reclassification – BSI’s Brooks

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers should start submitting design dossiers to notified bodies for their hip, knee and shoulder replacements to be reclassified as Class III devices in the European Union, according to BSI Americas VP Paul Brooks

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UK Adopts EU Directive For Tighter Rules On Orthopedic Implants

The United Kingdom has passed legislation to comply with a European Union directive to increase scrutiny of hip, knee and shoulder replacements

International In Brief

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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