ISO/TR 24971:2020-06

ISO/TR 24971:2020:06 – Guidance for risk management of medical devices according to ISO 14971

ISO/TR 24971:2020 is a guidance document (Technical Report) for the practical application of ISO 14971:2019.

It describes how the requirements for risk management of medical devices – including software and IVD – can be implemented in everyday practice.

Purpose of ISO/TR 24971:2020-06 as implementation guidance for ISO 14971

The Technical Report serves as a practical guide for interpreting and implementing the standard. It conveys the content of ISO 14971 in an understandable and practice-oriented way, provides concrete examples and applicable methods, helps clarify typical interpretation questions in risk management, and also supports preparation for audits and regulatory inspections.

Content and focus areas of ISO/TR 24971 in the risk management process

• Risk management system & responsibilities
  Lifecycle-oriented process including management responsibility and risk acceptance criteria.
• Risk analysis and risk evaluation according to ISO 14971
  Modeling of hazard–harm chains as well as qualitative and semi-quantitative evaluation methods.
• Risk control measures for medical devices
  Selection, combination, and verification of effectiveness of design, protective, and informational measures.
• Overall risk and benefit-risk analysis
  Assessment of residual overall risk and structured benefit-risk trade-offs.
• Post-market surveillance in risk management
  Integration of PMS, vigilance, and CAPA data into the continuous risk management process.
• Methods and special topics in the annex (Annex)
  Overview of methods such as FMEA, FTA, as well as requirements for software, security, and IVD.

ISO/TR 24971 in the regulatory context (MDR, ISO 13485)

• not a normatively binding document
• however recognized as the state of the art
• frequently used as an audit and regulatory reference
• particularly relevant in combination with ISO 13485:2016 and MDR/IVDR

Conclusion

ISO/TR 24971:2020 is a practical guidance document for the application of ISO 14971:2019 and supports manufacturers in implementing a structured and traceable risk management system across the entire product lifecycle.

The Technical Report clarifies key steps such as risk analysis, risk evaluation, selection of risk control measures, and the integration of post-market surveillance. As a result, typical implementation questions in risk management are addressed in a clear and practice-oriented way.

It is particularly helpful for complex topics such as hard-to-quantify risks, software and IVD products, and benefit-risk evaluation.

In the regulatory environment – especially in combination with ISO 13485:2016 as well as MDR and IVDR – ISO/TR 24971 is considered a recognized interpretative aid and is frequently used in audits as evidence of “state of the art” risk management.

Overall, ISO/TR 24971:2020 serves as important support for compliant, consistent, and audit-ready risk management according to ISO 14971.

This document replaces ISO/TR 24971:2013-07 .