The impact of significant changes to high-risk AI systems must be assessed in advance and executed in a controlled way. The consequences of unintentional changes must be assessed and efforts made to mitigate possible adverse effects.
This process must also include analysing data from the post-market monitoring system to identify new or previously unknown risks. Findings from these evaluations should be used to regularly update the system's risk management plan.
Significant changes may include: changes in the organization, operating environment, business processes and data systems as well as changes to high risk systems that require formal evaluation, documented risk assessment and approval prior to implementation. Changes can be identified e.g. through management reviews and other work associated with the development and maintenance of high-risk AI systems.
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