CEN ISO/TR 24971:2020

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

Publication date:   Oct 14, 2020

General information

60.60 Standard published   Jul 22, 2020


CEN/CLC/JTC 3 Quality management and corresponding general aspects for medical devices

Technical Report

11.040.01   Medical equipment in general



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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


CEN ISO/TR 24971:2020
60.60 Standard published
Jul 22, 2020