The four mandatory modules
On 28 May 2026, four modules became mandatory — triggered by Commission Decision (EU) 2025/2371, with 750,000 UDIs added in weeks.
Free field guide · PDF
EU EUDAMED: Mandatory Use2026 Field Guide
The four mandatory modules, the two pending, and the 2.5M-device flood — with the EUDAMED practice you need.
- Modules live
- 4 / 6
- UDIs registered
- ~2.5M
- Legacy deadline
- Nov 2026
Sourced from verified 2026 publications.
Download the free guide
Enter your work email and we'll send the PDF straight to your inbox.
What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The two pending modules
PMSV under audit (OJEU estimate Q4 2026, mandatory six months after); CI/PS still in development with no publication date.
The legacy-device clock
Legacy devices already on the EU market must be registered by 28 November 2026 — with M2M queues already seeing delays.
Sources & scope
- emergobyul.com, EAAR 2026: Key EU Regulatory Developments.
- linkedin.com/pulse, Richard Houlihan, Mandatory EUDAMED. Successful? What next? (Jun 2026).
- meddeviceguide.com, MDCG 2026-4: Who Uploads SSCP and SSP to EUDAMED (June 2026).
This guide is market-access intelligence, not regulatory or legal advice. EUDAMED timelines, module status, and registration practice change — professional review is required before business use.
Market Access Strategy Session
EUDAMED on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your EUDAMED readiness — module obligations, legacy-device registration, and PMSV timing.
Professional review is required before business use.
Back to ghmap.io Questions? Talk to our team