The reporting clock
MDR Art 87: 2 days for public-health threats, 10 for death/unanticipated deterioration, 15 for other serious incidents.
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EU Vigilance & PMSV2026 Field Guide
The reporting clock, the PMSV module, and the supply duty — with the post-market practice you need.
- Reporting days
- 2/10/15
- PMSV est.
- Q4 2026
- Supply notice
- 6 mo
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 PMSV module
PMSV in audit (OJEU est. Q4 2026), CI/PS still in development, and the Nov 28, 2026 legacy-device deadline.
The supply duty
Regulation (EU) 2024/1860: 6-month advance notice of discontinuations and supply interruptions since Jan 2025.
Sources & scope
- emergobyul.com, EAAR 2026: Key EU Regulatory Developments.
- ddismart.com, EUDAMED Vigilance Requirements and Steps.
- meddeviceonline.com, PMS And Supply Chain Visibility For EU Compliance.
This guide is market-access intelligence, not regulatory or legal advice. EUDAMED module status, reporting obligations, and transitional provisions change — professional review is required before business use.
Market Access Strategy Session
EU post-market on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your EU post-market route — PMSV readiness, vigilance SOPs, and supply-duty compliance.
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