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.
What to expect
- Validated by regulatory experts
- Ad hoc regulatory consultant expertise
- Foundation support
- GDPR handling
- AI is trained under law text
- Replace Notified Body final assessments
- Provide legal or regulatory binding advice
- Handle direct regulatory submissions
- 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.
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.