All terms
AI Act Serious Incident Reporting
Duty on providers of high-risk AI systems to report serious incidents to national market-surveillance authorities.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed July 25, 2026
Definition
Article 73 obliges providers to report any serious incident involving a high-risk AI system to the market-surveillance authority of the Member State where the incident occurred. Serious incident is defined in Article 3(49) and includes death, serious harm to health, serious and irreversible disruption of critical infrastructure, breach of fundamental rights, or serious harm to property or the environment.What this means in practice
For medical devices, reporting timelines and channels align with MDR Article 87 vigilance reporting for incidents already reportable under device law, avoiding duplicate submissions. Manufacturers should update their vigilance procedures to reference both regulations.Related terms
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510(k) Premarket Notification(510(k))
FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Regulatory
510(k) Summary vs 510(k) Statement
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Regulatory
513(g) Request for Information(513(g))
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
Regulatory
Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Cited by
Where this term appears across MedTech Terms.
Ecosystems (4)
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
EUR-Lex·1FDA·1European Commission·1
- 1
Regulation (EU) 2024/1689, Article 73VerifiedEUR-Lexeur-lex.europa.eu
- 2
FDA - Medical DevicesVerifiedFDAfda.gov
- 3
European Commission - Medical DevicesVerifiedEuropean Commissionhealth.ec.europa.eu
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