ISO 14971:2019

ISO 14971:2019 specifies the terminology, principles, and a process for the risk management of medical devices, including in vitro diagnostic (IVD) medical devices. It provides a framework for manufacturers to identify hazards, estimate and evaluate risks, control risks, and monitor the effectiveness of controls throughout the product lifecycle.

Overview

Background

Published by the International Organization for Standardization (ISO), this standard is the foundational risk management standard for the medical device industry. The 2019 edition updated the 2007 version to better align with other standards in the ISO 13485 family and to clarify requirements for benefit-risk analysis, production and post-production activities, and the overall residual risk evaluation.

Applicability

This standard applies to manufacturers of medical devices and IVD medical devices at all stages of the product lifecycle. It is referenced by virtually all major regulatory frameworks including the EU MDR, EU IVDR, FDA Quality System Regulation, and Health Canada regulations. It is the universal benchmark for risk management processes in the medical device industry.

Core Principles

Hazard identification and risk estimation

Risk evaluation against defined criteria

Risk control option analysis and implementation

Residual risk evaluation and acceptance

Benefit-risk analysis for residual risks

Production and post-production information review

Overall residual risk evaluation

Risk management documentation and traceability