Comment: Should the EC look again at its regulatory armoury?
This article was originally published in Clinica
Executive Summary
Once again, it is the issue of breast implants that brings to the fore some unsettling questions about the way the EU's medical device regulatory system is working. This time, it is the European Commission's paper on how member states have responded to its Communication on Community and National Measures in relation to Breast Implants that raises questions over the best approach to addressing doubts about the ability of the medical device directives to guarantee the safety of potentially high-risk products.