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CE notified body oversight - a system in need of overhaul?

This article was originally published in Clinica

Executive Summary

Is the European regulatory system for medical devices strong enough to ensure its continued survival, or does the apparent lack of control by competent authorities over their notified bodies threaten its continued existence as a system that relies on manufacturer responsibility rather than policing? Amanda Maxwell reflects on a question that has haunted the medical devices regulatory system since the directives came into force.

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