Notified Body Change Notification — 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 NB change notification system covering EU MDR Art. 56(2), MDCG 2020-3 Rev.2 (substantial change framework), Annex IX-XI conformity assessment routes.
What’s included:
- SOP-ISO-35 Notified Body Change Notification — pre-submission strategy, package preparation, response management, authorization-to-implement gate.
- F-ISO-35.1 NB Change Notification Form (Word) — pre-submission meeting tracking, MDCG 2020-3 substantiality matrix integrated (9 questions), 12-row supporting evidence checklist, NB response tracking post-submission.
Why this package: Substantial changes to CE-marked devices require NB notification BEFORE implementation. This package gives you the complete submission infrastructure.
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.