--- title: "AI Act Serious Incident Reporting… | MedTech Terms" description: "Duty on providers of high-risk AI systems to report serious incidents to national market-surveillance authorities." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ai-act-serious-incident-reporting#term", "name": "AI Act Serious Incident Reporting", "description": "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. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. AI Act Serious Incident Reporting [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[AI / ML in Devices](/ecosystems/ai-ml)[Quality System](/ecosystems/quality-system)[Post-Market & Safety](/ecosystems/post-market-safety) # 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 Cyber](/authors/christian-espinosa) Last 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](/terms/mdr-reporting) 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 Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Regulatory High-Risk AI System (EU AI Act) AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III. ](/terms/ai-act-high-risk-system) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ 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. ](/terms/510k-summary-vs-statement)[ 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. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (4) - [Regulated Pathways](/ecosystems/regulated-pathways) - [AI / ML in Devices](/ecosystems/ai-ml) - [Quality System](/ecosystems/quality-system) - [Post-Market & Safety](/ecosystems/post-market-safety) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 EUR-Lex· 1 FDA· 1 European Commission· 1 1. [1 Regulation (EU) 2024/1689, Article 73 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2024/1689/oj) 2. [2 FDA - Medical Devices Verified FDA fda.gov ](https://www.fda.gov/medical-devices) 3. [3 European Commission - Medical Devices Verified European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector_en) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Regulatory Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ai-act-serious-incident-reporting) Learn in 60 seconds Card Lesson Quiz Duty on providers of high-risk AI systems to report serious incidents to national market-surveillance authorities. - · 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. Remember this Duty on providers of high-risk AI systems to report serious incidents to national market-surveillance authorities. Related terms - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [EU Medical Device Regulation(MDR) ](/terms/mdr) You may also need Auto-suggested from Regulatory and shared keywords. - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [Medical Device Vigilance ](/terms/vigilance) - [Unanticipated Adverse Device Effect(UADE) ](/terms/uade) - [Emergency Use Authorization(EUA) ](/terms/eua) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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