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EU medtech notified bodies tackle unannounced inspections in updated code

This article was originally published in Clinica

Executive Summary

The European association of medtech notified bodies, Team-NB, has adopted a revised code of conduct with a new section calling for unannounced inspections of device manufacturers once every three years at least. Compliance with these specific recommendations will be voluntary for the foreseeable future; they will only become officially applicable for Team-NB members once new legal requirements mandating unannounced inspections come into force – and this will not happen for several years.

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