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

This article was originally published in RAJ Devices

Executive Summary

Following the publication of a number of key documents related to how notified bodies should audit their medical device clients1, the European Commission’s Notified Bodies Operations Group is now anticipating the planned revision of the In Vitro Diagnostics Directive (Directive 98/79/EC)2. It is looking at conformity assessment and related notified body issues within this context.

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