As mentioned in last week’s article – The Data Act’s relevance in 2026, back in 2024, the EU regulatory environment regarding data became more complex, as The Data Act, the Artificial Intelligence (AI) Act, and NIS 2 came into force. In August 2024, our Founder & Executive Board Member Jörg Dogwiler assessed the impact of these intertwined regulations and directives on medical device manufacturers in a trio of downloadable articles.

Following on from our refreshed overview of The Data Act (Regulation (EU) 2023/2854), this week Jörg re-looks at the AI Act’s relevance for manufacturers of medical devices in the EU and Switzerland.

Available to download below, the article outlines a refreshed, up-to-date overview of the legislation, summarising how the horizontal EU Artificial Intelligence Act interacts with the vertical legislations EU MDR and IVDR on some key compliance topics. It outlines the four-tier model for risk classification of AI systems, as well as the regulatory considerations regarding high-risk AI systems including conformity assessment, quality management, and technical documentation.

Access the full article within the document viewer or at the download button, and should you have an AI challenge related to your medical device, feel free to get in touch with our team of experts.