IMDRF

Medical Software - Updated: 2020/05/29 - 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: 2019/11/28 - 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!

2019/01/11 - Clinical Affairs - Updated: 2019/11/28 - Thorsten Prinz and Helene Kern

How to Perform Clinical Evaluation of Medical Software

Manufacturers must do a clinical evaluation of a medical device before they can market it in Europe. Find out what you need to keep in mind.

Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD). Monitor showing an ECG heartbeat line, a x-ray image of a hand and a graph, symbolizing medical stand alone software or Software as Medical Device (SaMD).

Stand-Alone Software as Medical Device

Thorough analysis of the intended purpose provides essential evidence for stand-alone software being a medical device on its own.

Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards Sheet of paper with a magnifying glass, showing a scale in the glass. It symbolizes the conformity with the law in harmonized standards
2019/01/07 - Medical Software - Updated: 2019/11/28 - Thorsten Prinz

Harmonized Standards for Medical Software

Harmonized standards are the first choice to achieve conformity with the EU MDR, but not all requirements are always covered.