This Notified Body Reportable Changes Procedure complies with ISO 13485:2016, EU MDR 2017/745, and European Guidance . Delivered in editable Word format, it defines how organizations identify, document, and report significant changes to their Notified Body to maintain certification and regulatory compliance. Digital delivery within 24 business hours.
This procedure supports medical device manufacturers in managing reportable changes that may impact certification or regulatory approval. It covers identification of changes, evaluation of regulatory impact, documentation, and communication with the Notified Body. Delivered in editable Word format for easy customization. Additional support is available for upgrading or adjusting procedures, and consultancy services can be arranged flexibly via email, Zoom, or on‑site visits. For clients requiring full implementation or signed, approved procedures, these services are offered at an extra fee.