Enhancing regulatory affairs in the market placing of new medical devices: how LLMs like ChatGPT may support and simplify processes

Abstract

The market placing of a medical device in compliance with the requirements of EU Regulation 2017/745 (Medical Device Regulation) demands advanced regulatory expertise and a high level of detail and depth, inevitably leading to significant human and time resources. In an era where Artificial Intelligence (AI) is already present in various aspects of daily life, the potential and opportunity to use AI tools in the scientific field, such as the CE marking process of medical devices, are being explored. This process consists of several phases and related activities, some of which have been chosen as significant examples to evaluate how and to what extent AI can add value in achieving their compliance. The article presents the overall results in terms of performance and reliability derived from generative AI tests using Large Language Models, such as ChatGPT, applied to some of the processes necessary for the market placing of a medical device. The method used focuses on the relationship between prompt quality and output quality, demonstrating the importance of prompt engineering in using these tools effectively alongside regulatory processes. It also emphasizes the need for end-users to have education, training, and understanding of the mechanisms of generative AI to optimize performance.

Keywords

• Artificial Intelligence (AI)
• CE marking
• ChatGPT
• Large Language Models (LLMs)
• Medical Device Regulation (MDR)
• Prompt Engineering