FDAnews
www.fdanews.com/articles/149723-implant-scandal-sparks-eu-medical-device-rule-revamp

Implant Scandal Sparks EU Medical Device Rule Revamp

September 26, 2012
The European Union said it wants tougher rules governing the safety and monitoring of medical devices after weak EU regulations were partly blamed for a global scandal over French-made breast implants.
Reuters