ISO/TR 24971:2020 — Medical devices — Guidance on the application of ISO 14971

A technical report providing guidance on the application of ISO 14971 to medical devices. It includes practical examples and detailed explanations for implementing risk management processes, including hazard identification techniques, risk estimation methods, benefit-risk analysis, and guidance on the risk management report. Essential companion document for anyone implementing ISO 14971.

Standard Details

• Standard Number: ISO/TR 24971:2020
• Type: ISO Technical Report
• Published by: ISO
• Official Link: https://www.iso.org/standard/74437.html

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.