Is it allowed to place a generative-AI system on the EU market without a written conformity declaration and risk assessment?

Last updated on October 4, 2025

NO — Under the EU’s new AI regulatory framework, providers cannot simply put high-risk or regulated AI systems on the market without documented safeguards. The rules require providers to carry out risk assessments, keep technical documentation and — for many systems — draw up and retain a written EU declaration of conformity that identifies the AI system and shows which obligations were met. That declaration and documentation must be kept available for national authorities for years after the system is placed on the market. In short: you’re not free to ship certain AI systems without those formal steps; the law makes those organisational and documentation steps mandatory to sell or operate covered AI systems in the EU.

 

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ%3AL_202401689

6/13/2024

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