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Standards Development
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.
1- In conjunction with the plenary meetings of ISO/TC 210 at AFNOR in December 2023, a workshop on benefit/risk management was held with interesting presentations showing examples of benefit estimation. The AFNOR experimental standard XP S 99-223 and the report ISO/TR 24971:2020 were reviewed by the JWG1 members. It was concluded that this report can be expanded with additional guidance on the estimation on benefit and the evaluation of overall residual risk in relation to the benefits. A detailed proposal with changes to several clauses in ISO/TR 24971:2020 and with a new Annex is attached to this form.
2- Convert ISO/TR 24971 into a Technical Specification AND re-designate it as PART 1; ISO/TS 24971-1 in line with the development of other parts in this series.
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