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Cook's Doherty says commission's new notified body texts mean EMA is not needed

This article was originally published in Clinica

Executive Summary

If the European Commission’s just-adopted Implementing Regulation and Recommendation on notified bodies were fully implemented in law, we would de facto have a system of special notified bodies; there would be no need for the proposed European Parliament ENVI compromise amendment for the European Medicines Agency to be involved in designating and oversight of “Special notified bodies” for devices.

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