The EU reporting clocks
Serious incidents, FSCA, and trend reporting — with the 2 / 10 / 15-day EU clocks and the documented PMS system.
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Medical Device Vigilance & Post-Market Surveillance2026 Field Guide
The EU reporting clocks, the FDA contrast, and the EUDAMED PMSV module — with the vigilance practice you need.
- EU public-health threat
- 2 days
- EU serious incidents
- 10–15 days
- FDA MDR reports
- 30 days
Sourced from 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 — regulatory guidance and verified 2026 publications.
The FDA contrast
30-day MDR reports, 5-day immediate-action reports, and Section 522 ordered surveillance — how the FDA differs.
What changes in 2026
MDCG 2025-10 is the playbook; the EUDAMED PMSV module is estimated for OJEU publication in Q4 2026.
Sources & scope
- mantrasystems.com, How EU MDR Post Market Surveillance differs from FDA post-market expectations.
- emergobyul.com, EAAR 2026: Key EU Regulatory Developments.
- krohnbioconsult.dk, Regulatory Intelligence Newsletter (Dec 2025) — MDCG 2025-10.
This guide is market-access intelligence, not regulatory or legal advice. Vigilance rules, timelines, and reporting practice change — professional review is required before business use.
Market Access Strategy Session
Vigilance on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your vigilance route — PMS system design, reporting-clock readiness, and EUDAMED PMSV preparation.
Professional review is required before business use.
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