The deadlines
The deadlines: Class D → Dec 2027, Class C → Dec 2028, Class B / sterile A → Dec 2029 — all conditional.
Free field guide · PDF
EU IVDR Transition2026 Field Guide
The deadlines, the checkpoints, and the practice — with the transition work you need.
- Need NB
- 80%
- Checkpoints
- 3
- End dates
- 2027–29
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 checkpoints
The checkpoints: QMS → NB application → signed NB agreement — per-class dates you cannot miss.
The practice
The practice: no-significant-change rules, supply-notification duties, and the 18–24-month queue.
Sources & scope
- Aurevia QARA, The IVDR Transition Is Not Over: Key Deadlines and Common Pitfalls (LinkedIn, 2026).
- sgs.com, Is Your Class C IVD Transition on Track? (Apr 2026).
- tuvsud.com, In Vitro Diagnostic Regulation (IVDR).
This guide is market-access intelligence, not regulatory or legal advice. IVDR transition requirements, EUDAMED timelines, and notified-body practice change — professional review is required before business use.
Market Access Strategy Session
IVD on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your IVDR route — checkpoint sequencing, NB strategy, and documentation planning.
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