---
title: Finally released – Guideline for medical device SW i EU
description: 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 […]
---

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# [Finally released – Guideline for medical device SW i EU](https://www.aurevia.com/news/we-are-pleased-to-share-some-great-news-about-the-further-strengthening-of-our-quality-and-regulatory-team-2-2)

 Written by [Aurevia](https://www.aurevia.com/news/author/aurevia) | 11 Oct 2019

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](https://ec.europa.eu/docsroom/documents/37581/attachments/1/translations/en/renditions/native)**

[Link to European Commision](https://ec.europa.eu/docsroom/documents/37581?locale=en)

[**A short introduction – 191014****  
**Intro to the MDR & IVDR SW Guidance (download link)](https://www.qadvis.com/wp-content/uploads/2019/10/Intro-to-the-MDR-IVDR-SW-Guidance.pdf)

[View full post](https://www.aurevia.com/news/we-are-pleased-to-share-some-great-news-about-the-further-strengthening-of-our-quality-and-regulatory-team-2-2)

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