Implant Scandal Sparks Revamp of EU Medical Device Rules

Published: Sep 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. The plans will affect a huge range of products, from contact lenses to pacemakers to pregnancy testing kits to high-tech medical equipment such as life support machines. Major manufacturers of medical devices include Johnson & Johnson, Medtronic, Boston Scientific, Abbott Laboratories, Allergan and Smith & Nephew.

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