ISO TR 24971 Guidance on Risk Management published

Recommendation

5/6 June 2024

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The Technical Committee ISO/TC 210 (Quality management and corresponding general aspects for medical devices) has elaborated a new Technical Report ISO TR ISO/TR 24971:2020 Guidance on Risk Management. The 87 pages report has been published last month (June 2020). It is available in English and French.

Guidance on the application of ISO 14971 on Risk Management

The systematic analysis, controlling, and monitoring of risks for Medical Devices and Combination Products is required by several applicable regulations (e.g., the Medical Device Regulation or the 21 CFR Part 820). And it is essential to ensure that the product is and remains safe and effective. End of 2019, the third edition of ISO 14971 has been published, which is the standard for Risk Management of Medical Devices and Combination Products. The ISO 14971 is now accompanied by an update of the ISO TR 24971. This Technical Report provides additional guidance on how to implement a Risk Management System according to ISO 14971.

The TR 24971 includes a chapter on Production and post-production activities and several annexes with the following content:

• Identification of hazards and characteristics related to safety,
• Techniques that support risk analysis (e.g. PHA, FTA, ETA, FMEA, HAZOP, HACCP),
• Relation between the policy, criteria for risk acceptability, risk control and risk evaluation,
• Information for safety and information on residual risk,
• Role of international standards in risk management,
• Guidance on risks related to security,
• Components and devices designed without using ISO 14971,
• Guidance for in vitro diagnostic medical devices (including benefit-risk analysis).

The new ISO/TR 24971:2020 Medical devices — Guidance on the application of ISO 14971 provides additional background information and should help to implement a risk management process according to (EU) MDR 2017 / 745.