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)
