Can I read IVDR Significant Change Guidance MDCG 2022-6 on EtoBox?

IVDR Significant Change Guidance MDCG 2022-6 by md eda is a document available to read on EtoBox.

What is IVDR Significant Change Guidance MDCG 2022-6 about?

This document provides guidance for manufacturers on assessing whether changes to in vitro diagnostic medical devices are considered "significant" under Article 110(3) of the IVDR, which allows certain devices to continue being placed on the market during transitional periods if there are no significant changes to the device

Author

md eda

Language

EN