Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?

Abstract

Concerns have been raised over the quality of evidence on the performance of medical artificial intelligence devices, including devices that are already on the market in the USA and Europe. Recently, the Medical Device Regulation, which aims to set high standards of safety and quality, has become applicable in the European Union. The aim of this article is to discuss whether, and how, the Medical Device Regulation will help improve the safety and performance of medical artificial intelligence devices entering the market. The Medical Device Regulation introduces new rules for risk classification of the devices, which will result in more devices subjected to a higher degree of scrutiny before entering the market; more stringent requirements on clinical evaluation, including the requirement for appraisal of clinical data; new requirements for post-market surveillance, which may help spot early on any new, unexpected side effects and risks of the devices; and requirements for notified bodies, including for expertise of the personnel and consideration of relevant best practice documents. The guidance of the Medical Device Coordination Group on clinical evaluation of medical device software and the MEDDEV2.7 guideline on clinical evaluation also attend to some of the problems identified in studies on medical artificial intelligence devices. The Medical Device Regulation will likely help improve the safety and performance of the medical artificial intelligence devices on the European market. The impact of the Regulation, however, is also dependent on its adequate enforcement by the European Union member states.