Velferd srl’s Post

Good morning dear followers! In June 2024, the European Union signed the Artificial Intelligence (AI) Act into law. The AI Act was published in the Official Journal of the EU on 12 July 2024. It came into force in August 2024. This AI Act is the first globally binding horizontal legislation on AI and establishes a common framework for the use and provision of AI systems in the EU. The new act offers a classification for AI systems with different requirements and obligations adapted to a ‘risk-based approach’. Some AI systems that present ‘unacceptable’ risks are banned. A wide range of ‘high-risk’ AI systems, which may have a negative impact on people's health, safety or fundamental rights, are authorised, but subject to a number of requirements and obligations for access to the EU market. AI systems that present limited risks due to their lack of transparency will be subject to information and transparency requirements, while AI systems that present minimal risks to individuals will not be subject to further obligations. The regulation also sets specific rules for general purpose AI (GPAI) models and establishes stricter requirements for GPAI models with ‘high impact capabilities’ that could pose a systemic risk and have a significant impact on the internal market. It should be noted that this law takes into consideration medical devices that integrate an AI within them and not only, and MDCGs on the topic are likely to be issued by the Expert Group. Source: https://lnkd.in/gCAQS4X #AI #europeanparliament #risk #mdcg #medicaldevices #ivd #qualityassurance #regulatoryaffairs #vlfconsulting

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