Total product lifecycle regulatory considerations and recommendations for generative AI-enabled medical devices.

As generative artificial intelligence (GenAI) emerges within the healthcare ecosystem, the regulatory environment surrounding these technologies remains fragmented. Importantly, GenAI in healthcare requires adapting the established Total Product Lifecycle (TPLC) paradigm to non-deterministic, rapidly evolving software, translating it into concrete steps for pre-market evaluation, change controls, and post-market performance monitoring to keep devices safe and effective as they change. This manuscript elucidates the need for developers, healthcare providers, and clinicians to engage proactively with regulatory compliance during the development and deployment phases of genAI-enabled medical devices. By understanding the nuances of national and international regulations, stakeholders can better navigate the unique risks of the evolving landscape of GenAI-enabled medical devices, while ensuring patient safety and outcome optimisation. Finally, this manuscript highlights the importance of the TPLC approach in managing the risks associated with GenAI-enabled technologies, offering recommendations for improving health outcomes and balancing the interests of various stakeholders.