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...
Draft Amendment to the MDR (2025): Implications for Class I Software
In the currently valid version of the Medical Device Regulation (MDR), there is considerable room for interpretation when it comes to classifying software medical devices. In particular, the distinction between risk classes I and IIa is vaguely worded. Manufacturers,...
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....
Class I Software according to MDR – is that still possible? (December 2025)
Are there still Class I software medical devices according to MDR? Are regulatory authorities really withdrawing Class I software products from the market in droves? Which federal state do I need to go to in order to remain on the market with my Class I software? As...
Classification of software medical devices: MDR Guideline
“The use of my app is completely safe. It certainly falls into the lowest risk category.”- MDR probably sees it differently. Anyone who wants to certify their software as a medical device in accordance with the Medical Device Regulation (MDR) must deal...
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