Blog

Insights and updates on health tech regulation and MDR compliance.

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  Why the MDR Feels Like a Black Box (And How to Shine a Light In)

  13 March 20263 min read

  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 Nothing” A founder of a Class IIa digital therapeutic put it bluntly: “We built our roadmap around a 9–12 month MDR timeline. Eighteen months later, we still don’t have a clear answer – jus

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  When Does Your Product Become a Medical Device?

  12 March 20264 min read

  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, your intended purpose, is what pulls you into the medical‑device world, with all the obligations that follow.   Intended purpose: the one sentence that changes everythi

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  Welcome to the official Health Tech Pathways blog.

  10 March 20261 min read

  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, and the challenges that health tech teams often face when bringing new solutions to market. We’re just getting started, and we’re excited to