Implant scandal sparks revamp of EU medical device rules

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Implant scandal sparks revamp of EU medical device rules



To match Special Report BREAST-IMPLANTS/MASBRUSSELS (Reuters) - The European Union has proposed tougher rules on assessing the safety and monitoring the use of medical devices and implants, after weak EU regulations were partly blamed for a global scandal over French-made breast implants. Investigations last year showed that hundreds of thousands of women around the world had been implanted with substandard silicone implants made by defunct French company Poly Implant Prothese (PIP), which safety regulators had failed to stop for more than a decade. ...









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