EU-AIA-73-11
Reporting
73 — Reporting of serious incidents
Limited notification for medical device AI systems
Description
Full Analysis & Evidence Requirements
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EU-AIA-73-01
Reporting
Report serious incidents to market surveillance authorities
EU-AIA-73-02
Reporting
Report serious incidents within 15 days after establishing causal link
EU-AIA-73-03
Reporting
Report widespread infringement or serious incidents within 2 days
EU-AIA-73-04
Reporting
Report death-related incidents within 10 days
EU-AIA-73-05
Reporting
Submit initial incomplete report when necessary for timely reporting
EU-AIA-73-06
Risk Management
Perform necessary investigations after reporting serious incident
EU-AIA-73-07
Prohibition
Prohibit alteration of AI system during investigation without authority notification
EU-AIA-73-08
Reporting
Market surveillance authority must inform national public authorities of specific incidents
EU-AIA-73-09
Requirement
Market surveillance authority must take appropriate measures within seven days
EU-AIA-73-10
Reporting
Limited notification for systems with equivalent reporting obligations
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