Regulation & safety4 min read

Global harmonisation

As AI crosses borders, regulators are aligning standards so a validated system can be approved — and monitored — everywhere.

AI systems are global: the same model can serve a hospital in Paris, Nairobi and Buenos Aires. Divergent national rules create friction — for manufacturers and, ultimately, for patients. Global regulators are responding through the International Medical Device Regulators Forum (IMDRF) and converging guidance on good machine-learning practice.

Harmonisation also matters for evidence. A model validated in one country should be re-checked before deployment in another, because populations and equipment differ. Global alignment of standards, combined with local validation, is the emerging consensus.

Harmonisation in practice

  • Shared principles for good machine-learning practice
  • Converging requirements across FDA, EU and others
  • Mutual recognition of common technical standards
  • Local validation before any cross-border deployment

In brief

The IMDRF aligns guidance on medical AI worldwide.
Standards are converging across FDA, EU and other regulators.
Local validation remains necessary before deployment.

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