The European Commission has just published the infographic titled “Is your software a medical device?”

This infographic outlines the main steps to qualify software as a medical device or in vitro diagnostic medical device under Regulations (EU) 2017/745 and (EU) 2017/746.

This document illustrates the MDCG Guidance 2019-11 on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR.

To consult the MDCG 2019-11 guidance directly online:




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