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Glossary Term
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ISO/TR 24971 (Guidance on the Application of ISO 14971 for Risk Management of Medical Devices)

Definition

ISO/TR 24971 is a technical report offering detailed guidance on applying the principles and requirements of ISO 14971. It helps medical device manufacturers understand and address complex aspects of risk management, such as evaluating residual risks, managing risk-benefit analysis, and documenting risk management activities for regulatory compliance.

Relevance to the MedTech Industry

ISO/TR 24971 assists manufacturers in effectively implementing risk management processes throughout the lifecycle of medical devices. It clarifies how to handle challenges in applying ISO 14971, ensuring that devices meet safety standards and regulatory requirements while minimizing risks to patients and users.

Additional Information & Related Terms

Key Topics in ISO/TR 24971

  1. Risk Management Process Guidance

    • Explains how to apply each stage of the ISO 14971 process, from risk analysis and evaluation to control and review.

  2. Risk-Benefit Analysis

    • Provides methods for assessing whether the benefits of the device outweigh its risks, considering residual risks and clinical data.

  3. Evaluation of Residual Risks

    • Clarifies the assessment of risks remaining after applying control measures, ensuring they are acceptable.

  4. Risk Communication

    • Guides how to communicate risks effectively in labeling, instructions for use (IFU), and training materials.

  5. Software and Cybersecurity Risks

    • Offers insights on managing risks specific to software-driven devices and cybersecurity vulnerabilities.

  6. Usability and Human Factors

    • Integrates principles from ISO 62366 and usability engineering to address risks related to device use errors.


Examples of Applications

  • Implantable Devices: Evaluating biocompatibility risks and managing residual risks for long-term implants like pacemakers or stents.

  • Software as a Medical Device (SaMD): Addressing unique risks such as data corruption, cybersecurity threats, or algorithm inaccuracies.

  • Single-Use Devices: Managing risks related to material selection, sterility assurance, and disposal.

  • Home-Use Medical Devices: Incorporating human factors to address risks associated with non-professional users.

Related Terms

  • ISO 14971: The foundational risk management standard that ISO/TR 24971 provides guidance for.

  • Post-Market Surveillance (PMS): Informs the risk management process through real-world data and user feedback.

  • Residual Risk: A critical concept in ISO/TR 24971, referring to risks that remain after control measures are applied.

  • Risk-Benefit Analysis: Central to determining the acceptability of residual risks as outlined in ISO/TR 24971.

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