EU Vigilance Reporting — Process Package (ISO 13485)
€69.00
ISO 13485 & MDSAP Ready
Editable Word & Excel
ISO 13485 / MDSAP / FDA QMSR
Used by 100+ quality teams
Process Package
Complete EU vigilance system covering EU MDR Art. 87-92, MDCG 2022-21 (PSUR template), and EUDAMED submission process. 4-question reportability framework integrated.
What’s included:
- SOP-ISO-11 EU Vigilance Reporting — 4-question reportability framework (incident / device involvement / outcome / Art. 87(2) exclusion), 2/10/15-day timelines, EUDAMED submission.
- F-ISO-11.1 Periodic Safety Update Report (PSUR) (Word) — 11 sections aligned with MDCG 2022-21: Admin, Device, Sales, Benefit-Risk, PMCF, Incidents/FSCAs, Complaints/Trends, RMF, Comparisons, Conclusions, Approvals.
Why this package: EU vigilance is mandatory and high-risk. Late or missed reports trigger NB action. This package gives you a defensible vigilance system.
Format: Microsoft Word (fully editable)
Updated: May 2026 — reflects EU MDR + FDA QMSR (Feb 2026) + latest MDCG guidance
Delivery: Instant download after purchase
€69.00
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Alessandro Stella
Alessandro Stella is a freelance Medical Device Regulatory Consultant and ISO 13485 / ISO 9001 Lead Auditor based in Italy. With over 13 years of experience spanning R&D, Quality, and Regulatory Affairs, he has supported companies across Europe and beyond in EU MDR technical documentation, QMS implementation, ISO 13485 compliance, and FDA submissions. His device expertise covers cardiovascular devices, AI-based standalone software, robotic surgery systems, active wearables, and more. Alessandro is the founder of MD Regulatory.