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

## TL;DR

This paper discusses how to regulate generative AI in medical devices by adapting the Total Product Lifecycle approach to ensure safety and effectiveness.

## Contribution

The paper introduces recommendations for applying TPLC to generative AI in medical devices to address regulatory challenges.

## Key findings

- Regulatory compliance must be integrated early in the development of GenAI-enabled medical devices.
- The TPLC approach can help manage risks and ensure ongoing safety as these devices evolve.
- Stakeholders need to understand and navigate both national and international regulations.

## Abstract

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.

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