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.
- 11 June 2026
The EU AI Act's high-risk deadline is still 2 August 2026. A proposed deferral has not changed what you must hold.
A provisional EU agreement in May 2026 proposes to defer the AI Act's high-risk obligations to 2027 and 2028. It is not yet law: the enacted date, 2 August 2026, still binds. Whichever date applies, the same record a preflight produces answers both the AI Act and the draft GMP Annex 22.
- 11 June 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 and formal adoption is expected this year. Almost every requirement it names is something you can check before the rule lands.
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Regulatory change for AI workflows, read as a preflight checklist. Weekly, plus notable items as they land.