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PM-011HighProviderCorrective

Stakeholder and Affected Person Notification

When serious risks are identified through post-market monitoring, providers must notify affected deployers and, where required by competent authorities, implement measures to inform affected natural persons of the risk and available remedies.

Articles:Article 20(2)Article 73(3)

Evidence Examples

  • Stakeholder notification procedure
  • Deployer risk communication template
  • Affected person notice procedure

Standards

ISO 42001:2023 §10.2

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Stakeholder and Affected Person Notification (PM-011) | AZComply Controls