The AI Act, the world's first legislation regulating the development, placing on the market and use of artificial intelligence systems, is about to come into force. Although the debate on liability currently focuses mainly on civil law remedies - which, by their very nature, are a particularly effective means of protecting people harmed by artificial intelligence systems - the advent of AI will also have an impact on criminal liability. In our previous articles, we have already provided a detailed overview of the subjects covered by the AI Act. In this article, we will therefore look at the scenarios opened up by the Regulation, with particular reference to the criminal law implications for players such as the provider and the deployer.

New amendments on the - somewhat rocky - road of the medical device (MDR) and in-vitro diagnosEcs (IVDR) regulaEons. Last 23 January 2024 the Commission presented an amendment proposal (COM 2024 – 43 final) which was fast tracked through and approved by the EU Council on 24 May. It will shortly be published in the Official Journal (Guce).