Expectation is that AI systems used in the development, manufacture or monitoring of medicines and medical devices to comply with existing GxP standards.
The FDA has made clear that AI/ML-based systems, including Software as a Medical Device (SaMD), are subject to the same regulatory controls as other medical technologies.
Edit your Features from the Pages tab bThe European Medicines Agency expects AI to operate within established GxP frameworks, including GMP, GVP and GCP.y clicking the edit button.
The EU AI Act introduces a risk-based framework for AI systems, with many life sciences applications likely to be classified as high-risk.