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.

Why it matters

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.

Common pitfalls

•Assuming every AI error is a serious incident. Reportability depends on the statutory incident categories and the circumstances, not simply an incorrect output.
•Assuming every medical-device incident needs identical submissions under the MDR and AI Act. The AI Act includes a specific reporting limitation for systems covered by EU medical-device legislation.
•Treating MDR vigilance procedures as sufficient without reviewing the AI Act. Procedures should also address fundamental-rights incidents and identify the appropriate authority and applicable reporting deadlines.

Sources

Regulation (EU) 2024/1689, Article 73 · EUR-Lex
FDA - Medical Devices · FDA
European Commission - Medical Devices · European Commission

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Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
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Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

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