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NBOG focus turns to notified body role in new and revised regulations

This article was originally published in Clinica

Executive Summary

After a flurry of recent publications in March of key documents related to how notified bodies should audit their medical device clients, the Notified Bodies Operations Group (NBOG) is now anticipating the planned revision of the IVD Directive. It is looking at conformity assessment and related Notified Body issues within this context.

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