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EU Parliament medtech report details rocky reg road ahead

This article was originally published in Clinica

Executive Summary

A sense of shock pervaded the medtech industry immediately after the 15 April publication of a draft report by the European Parliament’s rapporteur of the ENVI committee, Dagmar Roth-Behrendt, on the future regulation of medical devices. Controversial points made in the report include, among other things the introduction of premarket authorisation for medical devices and the re-use of all devices.