AI Act: Guidelines for Medical Device Manufacturers according to MDR (2026)
With the EU AI Act, the EU is now also regulating the use of artificial intelligence (AI). This also affects manufacturers of software medical devices who integrate AI into their MDR medical devices (“Medical Device Artificial Intelligence” or MDAI). The AI Act is...
Interoperability for Digital Health Applications (DiGA)
We would like to briefly introduce the topic of interoperability in DiGA development with a small example: “Μια DiGA πρέπει να πληροί ορισμένες απαιτήσεις διαλειτουργικότητας.” Do you understand this sentence? Unless you speak Greek, probably not. You therefore need...
DiGA price negotiations with the GKV-Spitzenverband
The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your...
MDR Guide: Clinical evaluation of software medical devices
“Clinical evaluation? No problem!” “A doctor was recently interviewed in the Süddeutsche Zeitung! She clearly stated that mindfulness apps help with depression. We can refer to that, can’t we?” Unfortunately, it’s not that simple....
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