Built on Real Regulatory Workflows
Not generic templates. The platform mirrors how teams actually prepare medical device documentation — step-by-step, with structured tasks, organised folders, and clear "what to include" guidance.
Your CE mark,
Faster
Getting your medical device CE marked can feel complex. We break the process down into clear, simple steps — from a free MDR check to a full regulatory workflow, with built-in AI support.
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Health Tech Pathways is operated by Health Tech Hub Copenhagen, a non-profit innovation hub bringing health tech to the healthcare sector. Join the hub.
What People Are Saying
How It Works
Breaking down regulatory compliance into bite-sized pieces.
1Describe Your Product
Tell us what you're building and who it's for. We turn your input into a clear description that fits regulatory expectations.
2Get Your Pathway
We show you if MDR applies, what risk class you fall into, and the route you'll need to take.
3Build What's Required
Follow a structured plan to create your documentation step by step. Instead of starting from scratch, you get guidance, templates, checklists, and a clear sense of direction.
- Built on official EU MDR guidance
- Reviewed by regulatory experts
- GDPR-compliant
- Not a submission service
- Not legal advice
- Not a guarantee of certification
Simple, Transparent Pricing
Start free. Upgrade when you're ready.
Validated and Trusted by Experts
Shaped and vetted by regulatory specialists. Grounded in official EU guidance.
Used by multiple industry experts.
Structured From the Get-Go
From day one, you work in a reviewable structure. Track progress, maintain consistency across documents, and reduce gaps that slow down internal reviews.
Transparent guidance you can explain
Know what's required — and why. Every step helps you understand the rationale behind decisions, so you can align stakeholders and defend choices with confidence.
Our partners
Everything You Need to Get CE-Ready
Plan, draft, and maintain your MDR documentation in one guided workflow.
Notified bodies & experts directory
Find the right experts faster. Compare specialization, scope, and collaboration models — connect when your project needs regulatory support. Less searching, better fit, faster progress.
Know the effort before you commit
Understand what drives effort and cost across your compliance journey — so you can plan realistically, prioritize, and avoid late surprises. Make timelines and budgets defensible.
Stay compliant after launch
Don't treat PMS (Post-market surveillance) as an afterthought. Plan your post-market activities early and keep documentation aligned as real-world feedback and changes come in. Keep your PMS evidence audit-ready — continuously.
News and Blogs
News and insights on health tech regulation, MDR compliance, and medical device pathways.
Blog
Picking the Right Regulatory Consultant for Your MDR Certification
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
Blog
Picking Your Notified Body: The Decision That Can Wreck Your Whole Timeline
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
Blog
How We Designed Health Tech Pathways
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
Frequently Asked Questions
Clear answers for teams building regulated products.
No. Our platform provides structural guidance, workflow automation, and templates based on the MDR 2017/745. It is designed to reduce uncertainty and preparation time, not to replace qualified legal counsel.
Still have questions?
Book a demo with one of our team members.
Start Your MDR Journey
Whether you're just getting started or already building, get clarity on your regulatory path and access the full workflow with Health Tech Pathways.