Implant Scandal Sparks Revamp of EU Medical Device Rules

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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