Dagmar proposals unfeasible and hanging on a thread?
This article was originally published in Clinica
Executive Summary
The more I think about it and the more I talk to others in the medical devices sector about European Parliament rapporteur Dagmar Roth-Behrendt’s proposals for centralised marketing authorisation by a new committee within the EMA and decentralised authorisation for some devices, the more convinced I am that her suggestions are unfeasible.