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Time for the EU's designating authorities to come under review?

This article was originally published in Clinica

Executive Summary

The five-year review of 93/42, the EU Medical Devices Directive, published this summer, identified the notified bodies as the critical elements in implementing the Directive. Surprisingly to some perhaps, the NBs emerged from the review with their reputation largely intact. Now, attention should be turned to the designating authorities, suggests Alan Kirwilliam, of UK notified body AMTAC





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