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.

Backed by

Novo Nordisk FoundationHealth Tech Hub Copenhagen

What People Are Saying

This is exactly the kind of tool I wished existed when I started supporting the many brilliant teams I have helped over the years. What excites me most is how it can help companies naturally develop a regulatory mindset — where the guidance offered genuinely helps them understand the purpose behind the requirements.
Natale Rolim
MedTech Regulatory Consultant, Norway
It's great to see how Health Tech Pathways can make one of the hardest parts of health tech innovation — regulatory approval — more accessible for early-stage hospital projects.
Rasmus Fält
Accelerator Lead, BETA.HEALTH
Before Health Tech Pathways, regulatory compliance felt like a black box. The platform breaks the process down into manageable steps and helps us understand exactly what needs to be done.
Mads Skak
CTO, Cacto Health
We recently held a workshop with Health Tech Pathways for our current cohort of startups. I have rarely seen such a clear and accessible explanation of regulatory requirements, covering what to consider and how to get started. The Health Tech Pathways tool was very intuitive and easy for our startups to use.
Peter Løvschall
Program Manager, KU Lighthouse
This is exactly the kind of tool I wished existed when I started supporting the many brilliant teams I have helped over the years. What excites me most is how it can help companies naturally develop a regulatory mindset — where the guidance offered genuinely helps them understand the purpose behind the requirements.
Natale Rolim
MedTech Regulatory Consultant, Norway
It's great to see how Health Tech Pathways can make one of the hardest parts of health tech innovation — regulatory approval — more accessible for early-stage hospital projects.
Rasmus Fält
Accelerator Lead, BETA.HEALTH
Before Health Tech Pathways, regulatory compliance felt like a black box. The platform breaks the process down into manageable steps and helps us understand exactly what needs to be done.
Mads Skak
CTO, Cacto Health
We recently held a workshop with Health Tech Pathways for our current cohort of startups. I have rarely seen such a clear and accessible explanation of regulatory requirements, covering what to consider and how to get started. The Health Tech Pathways tool was very intuitive and easy for our startups to use.
Peter Løvschall
Program Manager, KU Lighthouse

How It Works

Breaking down regulatory compliance into bite-sized pieces.

STEP 01

Describe 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.

STEP 02

Get Your Pathway

We show you if MDR applies, what risk class you fall into, and the route you'll need to take.

STEP 03

Build 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.

30-Day Free Trial

Trial

Free

no credit card required

  • 1 medical device
  • MDR qualification & classification
  • AI guidance
  • Consultant directory
  • Notified Body directory

No credit card · Cancel anytime

Most Popular

Pro

€299

per month · excl. VAT

  • Everything in Trial
  • Full CE marking journey
  • Unlimited medical devices
  • Unlimited team seats
  • Expert support from our team

Billed monthly · Cancel anytime

Get 2 Months Free

Pro Annual

€2,990

per year · excl. VAT · €249/mo

  • Everything in Pro
  • Pay for 10 months, get 12

Billed annually · Cancel anytime

Validated and Trusted by Experts

Shaped and vetted by regulatory specialists. Grounded in official EU guidance.
Used by multiple industry experts.

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.

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

KU Lighthouse
BETA Health
NNF Biomedical Design
Swiss Healthcare Startups
BII
MVA

Everything You Need to Get CE-Ready

Plan, draft, and maintain your MDR documentation in one guided workflow.

Notified Bodies & Experts Directory interface

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.

Pricing model dashboard

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.

Documentation workflow interface

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.

How we Designed Health Tech Pathways
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

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

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

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.

All newsAll blogs

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.