Reimbursement of software in the GKV medical aids directory (HMV)
Healthcare software manufacturers in Germany face a key challenge: How can digital solutions be used to generate revenue in the healthcare system? The market for privately paid products is small, and patients are often reluctant to pay for software out of their own...
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...
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....
Is your software a medical device? Guide 2026
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Software must also be classified as a regulated medical device under the Medical Device Regulation (MDR) if it is used for specific...
IEC 62304: Software Safety Classes A, B, C – Guide
“Our software cannot hurt anyone. It is bound to be safety class A.” We hear this sentence regularly in initial conversations. Sometimes it is true. Often our honest assessment is a different one. Some background: Alongside the risk class under the MDR, there is a...
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