IEC 62304: Software life cycle processes for medical devices
IEC 62304 specifies processes and activities that you must observe when developing software as a medical device. It sets out specific requirements for how you must develop and maintain your software. This applies both to standalone software (e.g., medical apps) and to...
Innovation fund: 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...
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,...
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...
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