Cyber Resilience Act (CRA) for MDR Medical Devices: Implications
It is 2026 and everyone is talking about the Cyber Resilience Act (CRA). The Cyber Resilience Act is new and it is big. Digital products have to meet strict cyber security obligations: report vulnerabilities, deliver updates, and do so across the entire product...
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...
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,...
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