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Article 73 of the EU AI Act requires providers of high-risk AI systems to report serious incidents to the national market surveillance authority on a 2/10/15 day clock. Coordinated with MDR vigilance for medical-device AI.
Article 73 codifies the post-market reality every operator faces eventually: AI systems fail. The reporting clock starts at awareness and runs 2 days for serious public-health threats, 10 days for death or serious deterioration of health, 15 days for any other serious incident. For medical-device AI the AI Act Article 73 clock runs in parallel with the MDR vigilance clock, same cadence, both clocks must fire, but coordinated submission to the medical-device competent authority and the AI market surveillance authority is permitted.
A practical guide to AI incident response under the EU AI Act. 6-step response plan, Article 26(5) reporting obligations, whistleblower protections, and real incident examples.
Read articleHealthcare AI sits at the intersection of two regimes: the EU AI Act + sectoral product law (MDR / IVDR). This guide covers Annex I embedded high-risk classification, the dual conformity assessment route, Article 73 incident reporting on top of MDR vigilance, and the 2 August 2028 deadline post-Omnibus.
Read articleArticle 55 of the EU AI Act binds providers of general-purpose AI models with systemic risk: model evaluations, adversarial testing, serious incident reporting under Article 55(1)(c), and cybersecurity. The 10^25 FLOP compute threshold triggers classification. Full Commission enforcement starts 2 August 2026. The Omnibus deal did not change this regime.
Read articleA practical 10-step compliance checklist for the EU AI Act. From AI inventory to ongoing monitoring: everything your business needs before enforcement begins.
Read articleEU AI Act penalty tiers explained. Article 99 fines up to EUR 35 million or 7% of turnover, enforcement mechanisms, civil liability, and how to avoid penalties. Series finale.
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5-minute scored assessment across People, Tools, Compliance, and Infrastructure. See where you sit on this topic in operational terms.
