EU Medtech Reform Proposals May Jeopardize Authorized Reps And Exacerbate 'Ghost' Problem
This article was originally published in Clinica
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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