For many health tech startups, MDR isn’t just “another regulation” – it’s the biggest unknown between a working product and real patients. Founders talk about submitting documentation, waiting months, and still not knowing what is happening inside the Notified Body “black box. “We Sent Our File In… And Then
Why intended purpose determines everything, borderline wellness vs. medical claims, software classification under EU MDR, and the risks of under‑classifying early Your product becomes a medical device the moment you promise it will do something for a health condition, not just for general wellbeing. Under EU MDR, that promise,
This space will be used to share updates, ideas, and insights related to digital health innovation and regulatory pathways. Our goal is to provide useful information for teams building health technologies and navigating complex regulatory environments. In the coming weeks, we’ll be publishing articles about product development, regulatory considerations,