The rules
The rules: all 22 Annex VIII rules by family — non-invasive, invasive, active, and the special cases.
Free field guide · PDF
EU MDR Classification2026 Field Guide
The rules, the ladder, and the practice — with the classification work you need.
- Rules
- 22
- NBs
- ~50
- Classes
- I–III
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The ladder
The ladder: Class I → III, Is/Im/Ir, NB requirements, and the wait times each class buys you.
The practice
The practice: the classification workflow, the cost implications, and the NB validation step.
Sources & scope
- hreinwald/skills_library, medical-device-compliance skill (github.com).
- enthropic-data-llc, compliance-test-registry — EU MDR index (github.com).
- artixio.com, System & Procedure Packs Under EU MDR Article 22.
This guide is market-access intelligence, not regulatory or legal advice. MDR classification practice, MDCG guidance, and notified-body interpretation change — professional review is required before business use.
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