Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

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.