Team-NB 's official position paper on the implementation of the AI Act offers key guidance for manufacturers of medical devices with artificial intelligence. The document analyzes the integration between the AI Regulation and the requirements already established by the MDR and IVDR, underlining the classification of devices with AI as high-risk systems.

AI in healthcare has transformative potential, but it also raises ethical and regulatory challenges. The WHO has published guidelines on the governance of AI, with a focus on large-scale multimodal models (LMMs). These systems can revolutionize medical diagnosis, scientific research and drug development, but it is essential to guarantee data security, transparency of algorithms and equity of access.

The IMDRF has published a Playbook for the evaluation of Artificial Intelligence and Machine Learning (AI/ML) medical devices, addressing safety, efficacy and regulatory requirements. Global harmonization of these medical devices is essential to ensure transparency, reliability and compliance.

The FDA has released a new document on the use of Artificial Intelligence (AI) in the life cycle of medical products, reinforcing the need for transparency, safety and regulatory compliance. The FDA has identified four priority areas: global collaboration to protect public health, support for regulatory innovation, development of standards and best practices, and continuous monitoring of AI performance. The guidelines address everything from algorithm evaluation and bias mitigation to the resilience and cybersecurity of AI-based medical products. This initiative reinforces the FDA's commitment to responsible innovation, ensuring that AI applied to health contributes to medical advances without compromising patient safety.