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Qualification and Classification of Software guidance published to support the implementation of the MDR and IVDR

Posted on 04.11.2019

The European Commission’s Medical Device Coordination Group endorsed the related Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR which was made available at DG GROW’s website on 11 October 2019.

This document defines the criteria for the qualification of software falling within the scope of the new medical devices Regulations and provides guidance on the application of classification criteria (rules) for software, which are set out in Annex VIII of both Regulations.