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prSRPS CEN ISO/TR 24971:2018

Medical devices - Guidance on the application of ISO 14971 (ISO/TR 24971:2020)

General information

10.99     Nov 14, 2018



Technical Report




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[24], 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. See also the ISO Handbook: ISO 13485:2016 — Medical devices — A practical guide[25].

Life cycle


prSRPS CEN ISO/TR 24971:2018
10.99 New project approved
Nov 14, 2018

Related project

Adopted from CEN ISO/TR 24971:2020

Adopted from ISO/TR 24971:2020