Finally released – Guideline for medical device SW i EU

We think that many of you have waited for the guideline for medical device SW in EU!

“Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR”
Direct download link

Link to European Commision

A short introduction – 191014
Intro to the MDR & IVDR SW Guidance (download link)