[ Introduction ISO/TR 24971:2020 ]

ISO published ISO/TR 24971:2020 in June 2020 to provide up-to-date guidance on the development, implementation, and maintenance of risk management systems for medical devices, including In vitro diagnostic medical devices.

This is identical to the structure of ISO 14971:2019 Medical Device Risk Management Application Requirements developed to actively improve the risks derived from the use of medical devices and related programs and provides guidance on the development, implementation, and maintenance of those requirements.

ISO/TR 24971 also supports manufacturers and related organizations and personnel to understand the role of international product safety and standards, develop policies for determining risk acceptance criteria, and apply production and post-production feedback to risk management.

This support distinguishes between information and possible risk disclosures for the safety of medical devices and enables the development of an overall risk assessment and risk management process.

This standard is a guideline and does not correspond to the standard that can be issued as a certificate.

[ Necessity of ISO/TR 24971:2020 ]

• •  Assist in maintenance and implementation of ISO 14971:2019 medical device risk management application requirements
• •  Increase the safety of medical devices by identifying the intended use of the medical device, related performance, and risks
• •  It is easy to help the understanding of risk management of various stakeholders including healthcare workers, government, patients, etc.
• •  Help relevant stakeholders other than medical device manufacturers to identify and control risks and verify their effectiveness

[ ISO/TR 24971:2020 Requirements ]

• Scope
• Normative References
• Terms and definitions
• General requirements for risk management system
• Risk analysis
• Risk evaluation
• Risk control
• Evaluation of overall residual risk
• Risk management review
• Production and post-production activities

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