As of August 1, the new EU AI law
Regulation 2024/1689 establishing harmonized rules for artificial intelligence (AI) – also known as the AI Regulation or KIVO,
in force.
The regulations concern the placing on the market, commissioning and use of AI systems in the EU.
The aim is to assess the risks associated with the use of AI systems as well as regulations on risk management, data security and documentation.
This also applies to medical devices with AI components.
Article 113 contains information on when which regulations apply.
Click here for the EU AI Act Compliance Checker.