Newly Revised ISO Standard Will Help Device Manufacturers Address Risk Management

Regulatory NewsRegulatory News | 17 December 2019 |  By 

Earlier this month, the International Organization for Standardization (ISO) unveiled its revised standard on the application of risk management to medical devices, giving more attention to the benefits expected from devices, as well other clarifications and additions from the previous version.
The revised standard, known as ISO 14971:2019, replaces the second edition from 2007 and introduces several new definitions on the terms “benefit,” “reasonably foreseeable misuse” and “state of the art.”
Kim Trautman from NSF International and Julian Thorn from NSF-ProSystem in Germany explained to Focus how the definition of “benefit” says that it “may arise from clinical outcome, the patient’s quality of life, outcomes related to diagnosis, positive impact from diagnostic devices on clinical outcomes, or positive impact on public health.”
The 36-page standard’s forward notes more of the changes, including: “The requirements to disclose residual risks have been moved and merged into one requirement, after the overall residual risk has been evaluated and judged acceptable.” In addition, the method for evaluating the overall residual risk and the criteria for its acceptability are now required to be defined in the risk management plan, the standard notes.
Trautman and Thorn also noted how production and post-production activities have been clarified and restructured in the revised standard.
For instance, they said there are more details on the information “to be collected and the actions to be taken when the collected information has been reviewed and determined to be relevant to safety. This includes review of risk management and determination if (re)-assessment of (new) risks is necessary, evaluation of impact on previous risk control and activities, actions for devices already placed on the market and considering the results as input for review of suitability of the risk management process.”
For senior management, the standard explains how they have to define a policy for establishing criteria for risk acceptability based on national/regional regulations and relevant international standards.
And prior to commercial distribution of the medical device, manufacturers will have to determine how to execute its risk management plan and document the results in a report.
The method to evaluate the overall residual risk is also clarified to allow for the use of reviewing data and literature for the device and similar marketed devices, Trautman and Thorn explained.
ISO 14971:2019 Medical devices — Application of risk management to medical devices


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