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New EU IVD Regulatory Reality: Bumpy Ride Or Smooth Sailing?

This article was originally published in Clinica

Executive Summary

Many European IVD manufacturers that do not need to involve EU notified bodies in the auditing of their products or systems will need to soon - probably shortly after the end of this decade. But with just 23 notified bodies designated to test products against the requirements of IVD Directive, how is the system to cope?

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