EU regulatory system tightens up further to silence the critics
This article was originally published in Clinica
Executive Summary
The run-up to the expansion of the EU from 15 to 25 countries has seen some of the most far-reaching shifts in the regulation of medical devices since the Directives were drafted over a decade ago. Mounting pressure over the last few years for tighter control over devices perceived to be particularly risky resulted in a series of landmark decisions in 2003 as the Commission showed itself no longer hesitant to use the regulatory tools available. Amanda Maxwell reports on a dynamic and challenging year