PM-009HoogAanbieder & GebruikerPreventief
Samenwerkingsprotocol voor markttoezicht
Aanbieders en gebruiksverantwoordelijken moeten protocollen opstellen voor samenwerking met nationale markttoezichtautoriteiten tijdens post-market surveillance-activiteiten, inclusief gegevensdeling, regelingen voor toegang ter plaatse en toezeggingen over responstijden.
Artikelen:Article 21Article 72(2)Article 74
Bewijs voorbeelden
- Surveillance cooperation protocol document
- Point of contact designation record
- Data access agreement with authority
Normen
Article 74 EU AI Act
Gerelateerde controles
- PM-001Post-Market Monitoring Plan EstablishmentArticle 72(3) requires providers to establish, document, and implement a post-market monitoring plan that proportionately reflects the nature of the AI…
- PM-002Operational Data Collection SystemProviders must implement a system for collecting and analysing relevant data on the performance of high-risk AI systems throughout their operational…
- PM-003In-Operation Performance TrackingProviders must continuously track performance indicators in operation, comparing actual performance against the baseline established during pre-market…
- PM-004Incident Detection and Root Cause AnalysisProviders must implement automated and manual mechanisms to detect incidents and near-misses in operation, and conduct root cause analysis for significant…
- PM-005Serious Incident Reporting to AuthoritiesArticle 73(1) requires providers and deployers to report serious incidents to the relevant market surveillance authority without undue delay after…
- PM-006Corrective Action ProceduresProviders must implement documented corrective action procedures that specify how identified performance issues, incidents, and non-conformities are…
Gerelateerde AI-verordening-begrippen
- Post-Market MonitoringProactive collection and review of experience gained from the use of high-risk AI systems, to identify any need for corrective or preventive actions and ensure continued compliance throughout the system lifecycle.
- Market Surveillance AuthorityThe national authority responsible for market surveillance activities under the Regulation, including investigating complaints, conducting inspections, accessing documentation, ordering corrective actions, and notifying serious incidents to the AI Office.
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