Blog

Insights and updates on health tech regulation and MDR compliance.

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  Picking the Right Regulatory Consultant for Your MDR Certification

  13 October 20263 min read

  Let's start simple. A regulatory consultant is the person who guides you through getting your medical device approved in Europe.  Most companies have never tried to get a product CE marked.  Your strengths is in the product innovation, healthcare understanding, business understanding - and very rarely in the regulatory domain.  That's why most companies decide to use an external consultant, who have done this before, that can guide them in the process of choosing the right Notified Body, discus

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  Picking Your Notified Body: The Decision That Can Wreck Your Whole Timeline

  18 September 20263 min read

  Let's start simple. If you want to sell a medical device in Europe, and it is above level 1 in MDR, (has an intended use, with a real potential risk, if it doesn't work as planned), you need to have it approved by the EU. The EU has outsourced this authorization to organisations, called a Notified Body. They check your device and confirm it's safe and follows the rules. Once they say yes, you get to put a CE mark on it. That's the stamp that means "this is legal to sell in Europe."  Picking whi

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  How We Designed Health Tech Pathways

  17 July 20263 min read

  In my last post, I shared why we built Health Tech Pathways. This one is about how we designed it — a look into our engine room. But how did we end up with this design and user experience?  It started with the customers  We have seen the frustration in the eyes of start-up founders when they realise how difficult, expensive, and time-consuming regulatory approval is. After we received the grant of EUR 4.2m from the Novo Nordisk Foundation in October 2024, we decided to understand that frustra

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  The Story Behind Health Tech Pathways: A note from the CEO

  14 July 20262 min read

  I'm often asked why we built Health Tech Pathways. So here it is.  It started on a dockside  In 2018, I gathered the first seven health tech start-ups on a dockside in Copenhagen. That was the beginning of Health Tech Hub Copenhagen. Since then, we have supported more than 120 start-ups and scale-ups, reaching more than 5 million people with innovative solutions. Along the way, one pattern kept repeating. Every start-up faces the same three barriers:  1. Funding  2. Market access — (i.e. f

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  The Risk Nobody Puts on the List

  20 May 20262 min read

  Why starting the regulatory conversation early is the smartest decision a health tech founder can make.  Health tech founders think about risk constantly. Market risk, technical risk, funding risk. There is one that almost never makes the list. And it is the one most likely to stop you.  It builds quietly. A vague product description. Pilots run without regulatory structure. A quality system nobody actually uses. None of it feels like a crisis at the time. Together, it becomes a problem that c

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

  20 April 20262 min read

  The Notified Body has not gone silent because your file is bad. It may have gone silent because no one told you what to expect, and no one inside is obligated to update you. That is not a bug in the process. It is the process. Most founders manage this quietly at first. A missed milestone gets reframed as a minor slip. A verbal estimate from the NB gets passed to the board as a commitment. The consultant adds a line item. Each thing seems handleable in isolation. Together, it becomes a problem

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  MDR Annex XIV in Plain Language

  1 April 20262 min read

  Most founders think clinical evaluation is a document. It is not. It is a process, and Annex XIV of the MDR defines exactly what that process requires. The founders who treat it as paperwork tend to discover the difference at the wrong moment. You write your evidence strategy around a competitor's device. You sketch a plan to handle PMCF after launch. You assume equivalence will hold. Each of those decisions seems reasonable in isolation. Together, they become a problem that cannot be solved wi

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  The MDR Questions Startups Ask Most

  1 April 20262 min read

  Most founders building a medical device spend their first regulatory conversation asking the wrong question. They ask: what do we need to do to get certified? The better question is: what does our product claim to do? That single answer determines every regulatory decision that follows. Your intended purpose is not a marketing choice. It is a legal one. Write it too broadly and you claim clinical capabilities you did not mean to assert. Write it too narrowly to avoid regulation and you create a

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  When Does Your Product Become a Medical Device?

  12 March 20262 min read

  One sentence on your website can turn your wellness app into a regulated medical device. Not the code. Not the algorithm. The sentence that describes what the product does. Founders pick their framing early. You write the app-store copy. You brief the marketing team. You pitch investors. Each decision looks fine on its own. Together, they build a regulatory story you did not mean to tell, and that story cannot be fixed with money or momentum. A quick explanation of what we are talking about

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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