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RM-010MediumProviderPreventive

Risk Communication to Stakeholders

Providers must communicate relevant risk information to deployers, affected persons, and competent authorities as required, including risk summaries in the instructions for use and technical documentation.

Articles:Article 9(2)(d)Article 13

Evidence Examples

  • Stakeholder risk communication plan
  • Risk summary in user documentation
  • Authority notification procedures

Standards

ISO 42001:2023 §7.4

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Risk Communication to Stakeholders (RM-010) | AZComply Controls