INTELLIGENCE

Regulatory change, read as a preflight.

Each item: what changed, which authority and clause, why it matters for AI workflows, and the preflight implication. Tied to the corpus Preclari checks against.

  1. 11 June 2026 · updated 20 August 2026

    The EU AI Act's high-risk deferral is now law. Stale guidance, not the deadline, is the new compliance risk.

    The Digital Omnibus (Regulation (EU) 2026/1744) entered into force on 27 July 2026, six days before the high-risk deadline the industry had prepared for. Standalone high-risk obligations now apply from 2 December 2027 and product-embedded ones from 2 August 2028; the Article 50 transparency duties and the start of enforcement arrived on 2 August 2026 as scheduled. The evidence record a preflight produces is unchanged. Guidance written to the old date is not.

  2. 11 June 2026 · updated 12 August 2026

    The EU has drafted the first GMP rules for AI. A preflight reads them as a checklist.

    The European Commission's draft Annex 22 sets the first GMP expectations for artificial intelligence in medicine manufacturing. The comment period closed in October 2025. There is no official adoption date, and EMA is reconsidering the draft's exclusion of generative AI. Almost every requirement it names is something you can check before the rule lands.

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