EU Council’s Authorized Rep Liability Demands: Counter-Arguments, Alternatives, And Threat To TTIP
This article was originally published in Clinica
Executive Summary
Fundamental legal anomalies are being identified that could shake the basis of proposals made by the Council of European Union to make authorized representatives fully liable for defective devices. These proposals, as they are, would mean that authorized representatives have to take up prohibitively expensive liability insurance in future to represent medical device and IVD manufacturers that do not have a base in the EU.