This document provides guidance on the development, implementation and maintenance of a risk management system for medical devices according to ISO 14971:2019.
The risk management process can be part of a quality management system, for example one that is based on ISO 13485:2016, but this is not required by ISO 14971:2019. Some requirements in ISO 13485:2016 (Clause 7 on product realization and 8.2.1 on feedback during monitoring and measurement) are related to risk management and can be fulfilled by applying ISO 14971:2019.
PUBLISHED
SRPS CEN ISO/TR 24971:2026
PROJECT
prSRPS CEN ISO/TS 24971-1:2026
10.99
New project approved
Jul 8, 2026