The EUDAMED module clock
The EUDAMED module clock: mandatory 6 months after the OJEU notice; the coordinated assessment's voluntary-to-mandatory path.
Free field guide · PDF
EU MDR Clinical Investigation2026 Field Guide
The EUDAMED module clock, the report rules, and the SSCP handover — with the EU practice you need.
- Module clock
- 6 mo
- Report due
- 1 yr
- SSCP rule
- 2026-4
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 report rules
The report rules: 1 year after completion, 3 months on early halt — public via EUDAMED before market placement.
The SSCP handover
The SSCP handover: the manufacturer uploads master and translations under MDCG 2026-4 — the NB only ticks the boxes.
Sources & scope
- health.ec.europa.eu, MDCG 2024-11 Q&A on the Eudamed gradual rollout.
- mdlaw.eu, MDCG: Publications of clinical investigation reports.
- meddeviceguide.com, MDCG 2026-4: Who Uploads SSCP and SSP to EUDAMED.
This guide is market-access intelligence, not regulatory or legal advice. EU clinical-investigation rules, EUDAMED rollout, and MDCG practice change — professional review is required before business use.
Market Access Strategy Session
EU investigation on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your EU route — investigation strategy, EUDAMED timing, and SSCP planning.
Professional review is required before business use.
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