The EUDAMED mandatory dates
Decision (EU) 2025/2371 and Regulation (EU) 2024/1860: the four EUDAMED modules turn mandatory on 28 May 2026.
Free field guide · PDF
Medical Device UDI Requirements2026 Field Guide
The EUDAMED mandatory dates, the new-vs-legacy rule, and the label-data sync — with the global UDI picture you need.
- EUDAMED mandatory
- 28 May 2026
- Legacy registration
- 27 Nov 2026
- EUDAMED registration
- Free
Sourced from EU regulatory 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 — EU regulatory guidance and verified 2026 publications.
New vs. legacy devices
New devices register before first placement; already-marketed devices by 27 November 2026 — and EUDAMED is not CE marking.
The label-data sync
Label and database must match exactly, and UDI regimes are converging — Swissmedic, Bahrain, and beyond.
Sources & scope
- mdxcro.com, EUDAMED Deadlines 2026: Mandatory Registration Dates for MDR & IVDR.
- informait.com, UDI Labeling Requirements: What Medical Device Manufacturers Need on Every Label.
- casusconsulting.com, EUDAMED Overview: EU Medical Device Database.
- arenasolutions.com, Understanding EU UDI Deadlines and Benefits for Medical Device Companies.
This guide is market-access intelligence, not regulatory or legal advice. UDI rules, deadlines, and database practice change — professional review is required before business use.
Market Access Strategy Session
UDI on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your UDI route — EUDAMED registration planning, label-data synchronization, and multi-market reuse.
Professional review is required before business use.
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