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International News In Brief

This article was originally published in The Gray Sheet

Executive Summary

MDD review: Orthopedic implants are included among devices that should be upclassified as part of the EU Medical Devices Directive review in MEP Minerva Malliori's 1report on health implications of the MDD. During discussions in the EP's ENVI committee March 18, the European Parliamentarian also suggested that the directive encourage member states to take additional device reuse precautions, ease clinical data availability for manufacturers, tighten postmarket surveillance and improve notified body monitoring. ENVI is scheduled to vote on the report April 22, with plenary approval expected in May. Manufacturers are lobbying against the orthopedic reclassification (2"The Gray Sheet" March 3, 2003, p. 11)...
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