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
Know if MDR applies to your device, what class you fall into, and prepare the right documentation — all in a matter of minutes, guided by AI built on official regulatory texts.
Backed by Novo Nordisk Foundation
How it Works
Breaking down regulatory compliance into bite-sized pieces.
1
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.
2
Get your pathway
We show you if MDR applies, what risk class you fall into, and the route you'll need to take.
3
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
Trusted By Design
Shaped by regulatory specialists. Grounded in official EU 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.
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.
Latest from our Blog
Insights on health tech regulation, MDR compliance, and medical device pathways.
Why the MDR Feels Like a Black Box (And How to Shine a Light In)
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
MDR Annex XIV in Plain Language
The legal source, referenced at every step Annex XIV is the part of the MDR that deals with clinical evaluation. It is also the part that catches most startups off guard. Not because it is complicated. But because people assume it means one thing and the regulation says another. This post walks through what Annex XIV actually requires, in plain language, with the exact legal reference for every point. All sources are from Regulation (EU) 2017/745. First: every device needs a clinical eva
The MDR Questions Startups Ask Most
Answered From Primary Legislation, Not Opinion If you're building a medical device and selling into the EU, you've probably already run into the alphabet soup: MDR, PRRC, QMS, CER, EUDAMED. And you've probably been given a lot of opinions about what all of it means. This post is different. Every answer below comes directly from Regulation (EU) 2017/745, the actual law, not from a consultant's interpretation of it. Where a specific article applies, we've cited it. You can look it up yourself.
Frequently Asked Questions
Clear answers for teams building regulated products.
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.