A blog about what is new (and old) in the world of active implantable medical devices 

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Changes in EU Rules for Medical Device Approvals

There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years.  One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has

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