ISO 14971:2019 — Medical devices — Application of risk management to medical devices

The international standard for applying risk management to medical devices. ISO 14971 establishes the framework and process for manufacturers to identify hazards, estimate and evaluate associated risks, control those risks, and monitor the effectiveness of controls throughout the product life cycle. Referenced by virtually every other medical device standard and required by the EU MDR/IVDR, FDA, and all major regulatory frameworks.

Standard Details

• Standard Number: ISO 14971:2019
• Type: ISO Standard
• Published by: ISO
• Official Link: https://www.iso.org/standard/72704.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.