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New rules will force EU medtech notified bodies to up their game

This article was originally published in SRA

Executive Summary

The European Commission has adopted two measures that it says are aimed at strengthening the safety of medical devices and restoring consumer confidence in the industry following the PIP breast implant affair1. The measures clarify the criteria to be met by notified bodies and the tasks these bodies have to undertake when they perform audits and assessments in the medical devices and in vitro diagnostics sector.




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