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International News In Brief

This article was originally published in The Gray Sheet

Executive Summary

EUDAMED: Competent authorities will be able to access adverse event reports throughout Europe by year-end in the first phase of the European Database on Medical Devices. Notified bodies and other parties, however, likely will not have access until 2004, according to the European Commission (1"The Gray Sheet" Feb. 10, 2003, p. 26)...

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MDD Needs Notified Body, Transparency Overhaul – European Commission

Medium-risk device categorization will be addressed by the European Commission in an upcoming proposal to modify Annex II of the Medical Devices Directive

MDD Needs Notified Body, Transparency Overhaul – European Commission

Medium-risk device categorization will be addressed by the European Commission in an upcoming proposal to modify Annex II of the Medical Devices Directive

International News In Brief

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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