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Will Your Current Conformity Assessment Certs Remain Valid As Long As You Hope?

This article was originally published in Clinica

Executive Summary

A row has erupted at EU level regarding the length of time that conformity assessment certificates given to manufacturers by notified bodies should remain valid once the new Medical Devices Regulation is fully implemented. These certificates are usually valid for five years but the anticipated transition period for the Medical Devices Regulation is three years.

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