Built on real regulatory workflows
Not generic templates. The platform mirrors how teams actually prepare MDR/IVDR documentation —step-by-step, with structured tasks, annex-aligned folders, and clear "what to include" guidance.
Regulatory Success. Simplified.
Navigate MDR certification with confidence using clear pathways, expert connections, and AI support.
New product
Start free MDR Assessment
Best for teams in early ideation or concept stage. Clarify whether your health tech falls under MDR/IVDR.
Scaling phase
Explore your CE roadmap
Already have a product that needs certification? Follow our structured compliance roadmap and discover what risk classification you are in.
A Product owned by Health Tech Hub Copenhagen and backed by NNF
How it Works?
A simple 3-step flow from “not so sure” to a clear compliance plan.
1
Value sprint: Start your MDR assessment.
Add key details and the intended purpose to your device description.
2
Define your regulatory strategy with confidence
Follow a guided wizard that walks you through the critical decisions (MD/IVD, classification, conformity assessment route) and shows exactly what they mean for your obligations.
3
Build documentation step by step
Instead of starting from a blank document, you get a structured plan: folders, checklists, sub-tasks, and What to include guidance - so you move faster and miss nothing important.
- Validated by regulatory experts
- GDPR handling
- AI trained on validated legal texts
- Handle direct regulatory submissions
- Provide legal or regulatory binding advice
- Guarantee certification success
Preparatory tool for pre Notified Body submission.
Expert Validation
Trust in regulated markets is built through authority, process, and transparency.
Audit-ready by design
From day one, you work in a reviewable structure. Track progress, maintain consistency across documents, and reduce gaps that slow down internal reviews and Notified Body discussions.
Transparent guidance you can explain
Know what's required - and why. Every step helps you understand the rationale behind decisions (classification, route, key obligations), 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 — and 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.
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.
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
Frequently Asked Questions
Clear answers for teams building regulated products.
Is your product a medical device under MDR?
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