A Regulatory Science for Medical Devices with Continuously Changing Properties in the Post-Marketing Phase

Abstract

Application of big data on human health, medical care, and scientific findings to health care has been accelerated by artificial intelligence (AI). Various types of healthcare devices using AI have been developed. Under the current regulatory framework, modification of medical devices is classified into minor or partial changes required for notification of the change or application for change submitted to the regulatory body, respectively. Thus, the characteristics of medical devices change in a step-by-step manner in the post-marketing phase. In contrast, the performance of AI-driven medical devices has the potential to change continuously through the application of real-world data in the post-marketing phase. The present regulatory framework for post-marketing changes to medical devices sets out step-by-step changes, but not continuous changes, while on the market. A new regulatory framework for innovative medical devices with continuous changes in their performance has been discussed by the Health Science Council of the Ministry of Health, Labour, and Welfare since 2018, and the revision of the Pharmaceutical and Medical Device Act sets out this regulatory framework. In this review, a concept for the regulatory review of AI-driven innovative medical devices is described.