Skip to main content
PM-010HighProviderDetective

Periodic Post-Market Review

Providers must conduct periodic reviews of post-market monitoring data and the effectiveness of the monitoring system, producing documented review reports that inform updates to risk management, technical documentation, and the monitoring plan itself.

Articles:Article 72(3)Article 9(1)(c)

Evidence Examples

  • Periodic monitoring review report
  • Review frequency schedule
  • Monitoring plan update records following review

Standards

ISO 42001:2023 §9.3

Upgrade when it needs to be

The free questionnaire returns preliminary signals. The Full Assessment turns real system material into a governed decision record - extraction, component separation, evidence, national overlays, and a review-ready dossier.

Start free risk preview
Periodic Post-Market Review (PM-010) | AZComply Controls