Class I Software according to MDR – is that still possible? (September 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...
Guide: Is your app a medical device?
That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Mobile apps must also be classified as a regulated medical device if they are used for specific purposes such as the diagnosis or...
Innovation Fund (2025): Funding for digital health solutions
Many manufacturers of medical software and health apps are faced with the question: How can digital solutions be used to build a sustainable business model? The market for self-paying patients in the German healthcare system is relatively small, and the path to...
All insights: Development and approval of software medical devices in 2025
Over the past ten years, we have learned a great deal about the development of software medical devices. We are pleased to share this expertise in our technical articles with (prospective) developers of Software as a Medical Device (SaMD) so that not everyone has to...
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