This chapter translates the Act’s legal text into an engineer-friendly blueprint. It details risk management duties (Art. 9), data governance and bias mitigation rules (Art. 10), transparency obligations (Arts. 13 and 52), human oversight mandates (Art. 14), technical robustness standards (Art. 15), conformity assessment pathways and CE marking (Arts. 11, 17, 43, 47), and post-market monitoring (Art. 61). Summaries, flowcharts, and compliance checklists enable readers to audit existing systems or design new ones that meet the regulation’s letter and spirit. Penalties and enforcement mechanics (Arts. 71–73 and 99) are also outlined to emphasise the cost of non-conformity.

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Compliance Requirements

  • Marcos Kauffman

摘要

This chapter translates the Act’s legal text into an engineer-friendly blueprint. It details risk management duties (Art. 9), data governance and bias mitigation rules (Art. 10), transparency obligations (Arts. 13 and 52), human oversight mandates (Art. 14), technical robustness standards (Art. 15), conformity assessment pathways and CE marking (Arts. 11, 17, 43, 47), and post-market monitoring (Art. 61). Summaries, flowcharts, and compliance checklists enable readers to audit existing systems or design new ones that meet the regulation’s letter and spirit. Penalties and enforcement mechanics (Arts. 71–73 and 99) are also outlined to emphasise the cost of non-conformity.