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EU notified body numbers still yet to bottom out

This article was originally published in Clinica

Executive Summary

EU notified body numbers are still sinking and the bottom is not yet in sight. This month Swissmedic announced that conformity assessment bodies (CABs) working in the EU medtech regulatory arena have been cut from five to three this year, in the wake of a new ordinance (MedDO) that authorizes unannounced visits to manufacturers, among other new responsibilities. Switzerland is indicative of the EU trend as it enacts EU medtech law and harmonizes with EU rules in order not to hinder its own trade.

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