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EU Medtech Reform Proposals May Jeopardize Authorized Reps And Exacerbate 'Ghost' Problem

This article was originally published in Clinica

Executive Summary

A new clause in the draft EU regulations for medical devices and IVDs - to make authorized representatives fully liable for defective devices in cases where the product manufacturer is not established in any EU member state - could have a devastating effect on how independent authorized representatives operate and force many of them to shut shop, warns the European Association of Authorised Representatives.

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