In Short
The Situation: The EU Artificial Intelligence Act (the "AI Act") introduces new obligations for providers and deployers of "high-risk AI systems," including risk management, data governance, transparency, human oversight, and registration in the EU database.
The Development: On May 19, 2026, the European Commission issued draft guidelines on the classification of high-risk AI systems under the AI Act (the "Guidelines"). The Guidelines are intended to assist providers, deployers, and market surveillance authorities in determining when an AI system should be classified as high-risk.
Looking Ahead: Although not binding, the Guidelines are expected to become a benchmark for market surveillance authorities when assessing high-risk classification. The consultation period closes on June 23, 2026, with the final Guidelines expected before the AI Act's high-risk obligations enter into force, currently anticipated for December 2, 2027 (for stand-alone high-risk systems under Annex