MDCG

Medical Software - Updated: 2020/10/14 - Thorsten Prinz

Legal Requirements for Medical Software

Our resources of legal requirements for medical software help you to find all important laws, guidelines, and standards.

A disc falling down, bumping on some pins, finally landing in one of the 4 bowls, labelled I, IIa, IIb and III. Symbolizing software classification according to EU MDR. A disc falling down, bumping on some pins, finally landing in one of the 4 bowls, labelled I, IIa, IIb and III. Symbolizing software classification according to EU MDR.
2019/07/11 - Medical Software - Updated: 2020/09/10 - Tobias Schreiegg and Thorsten Prinz

Software Classification: Insights in EU Guidance

The MDR caused uncertainty concerning software classification. We give you an exclusive insight into the upcoming EU guideline!

Tree Model for Classification Tree Model for Classification

Medical Device Classification: The Software Special

The EU MDR contains new rules for medical device risk classification. Stand-alone medical software usually ends up in higher classes.