The Class C 2026 milestones
NB application by 26 May 2026 and a signed agreement by 26 September 2026 — miss them and you lose the extension.
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IVD Medical Device Registration2026 Field Guide
The Class C 2026 milestones, the 80% NB flip, and the class-by-class timeline — with the transition practice you need.
- Class C NB agreement
- 26 Sep 2026
- Now need NB review
- ~80%
- Avg. NB certification
- 18–24 mo
Sourced from IVDR guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — IVDR guidance and verified 2026 publications.
The 80% flip
80% of IVDs were self-certified under the Directive; ~80% now need Notified Body review under the IVDR.
The class-by-class clock
Class D, C, B, and A-sterile transition ends from 2027 to 2029 — with NB transfer options if capacity bites.
Sources & scope
- sgs.com, Is Your Class C IVD Transition on Track? (Apr 2026).
- bsigroup.com, (EU) 2024/1860 — IVDR 26 September 2026 deadline approaching (Aug 2026).
- tuvsud.com, IVDR transition timeline.
- linkedin.com (Aurevia QARA), The IVDR Transition Is Not Over (2026).
This guide is market-access intelligence, not regulatory or legal advice. IVDR timelines, guidance, and Notified Body practice change — professional review is required before business use.
Market Access Strategy Session
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A Market Access Strategy Session maps your IVDR route — Notified Body selection, milestone planning, and class-by-class transition mapping.
Professional review is required before business use.
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