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.
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
When Does Your Product Become a Medical Device?
Why intended purpose determines everything, borderline wellness vs. medical claims, software classification under EU MDR, and the risks of under‑classifying early Your product becomes a medical device the moment you promise it will do something for a health condition, not just for general wellbeing. Under EU MDR, that promise, your intended purpose, is what pulls you into the medical‑device world, with all the obligations that follow. Intended purpose: the one sentence that changes everythi
Welcome to the official Health Tech Pathways blog.
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
Frequently Asked Questions
Clear answers for teams building regulated products.
Is your product a medical device under MDR?
Create an account to continue the MDR assessment. You'll be able to view the outcome in the platform once ready.