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French pressure results in European Commission proposing mandatory safety requirements

This article was originally published in Clinica

Executive Summary

The European Commission is proposing what are effectively mandatory safety requirements for breast implants in Europe. This is the first time in the ten-year history of the two medical device directives that mandatory requirements have been on the agenda. Amanda Maxwell looks at the wider implications and asks whether the whole basis of medical device legislation in Europe could be about to change.

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