The class ladder
The legacy ladder: custom-made III (ended May 2026), Class III/IIb implantable to Dec 2027, the rest to Dec 2028.
Free field guide · PDF
EU MDR: Transition Deadlines2026 Field Guide
The class ladder, the conditions, and the sell-off reset — with the EU practice you need.
- Class III
- Dec 27
- Class II
- Dec 28
- Sell-off reset
- 2024/1860
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 conditions
The cumulative conditions: MDR QMS, signed NB agreement, no significant changes — extension is never automatic.
The sell-off reset
Regulation (EU) 2024/1860 removed fixed sell-off deadlines: lawfully placed devices stay available without a time limit.
Sources & scope
- oxfordcorp.com, EU MDR Transition Deadlines (2026–2028).
- jamasoftware.com, EU MDR Compliance: Requirements, Timeline & Deadlines.
- bsigroup.com, (EU) 2024/1860 – IVDR 26 September 2026 deadline approaching.
This guide is market-access intelligence, not regulatory or legal advice. EU MDR/IVDR transition rules, NB capacity, and competent-authority practice change — professional review is required before business use.
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