UK PIP report largely vindicates EU medtech system but highlights need for improvements
This article was originally published in SRA
Executive Summary
Nothing about the PIP breast implant affair provides evidence to suggest that the EU medical device regulatory system is fundamentally unsound or that the EU needs to shift to a pharmaceutical-type regulatory system or even to a system such as that used to regulate higher- risk devices in the US. Nonetheless, the affair provides lessons on how the EU regulatory system might be improved.