EU must tackle clinical trials shortfalls as current lack of evidence is "appalling"
This article was originally published in Clinica
Executive Summary
With devices becoming increasingly complex, Competent Authorities must ensure there are sufficiently well-trained experts at Notified Body level, particularly for assessing innovative devices and for clinical trials. But authorities are facing difficult resource issues and finding experts is a real challenge. Dr Susanne Ludgate of the UK MHRA told Amanda Maxwell where the problems lie, and what she believes to be the solutions