TY - JOUR

T1 - Will the EU Medical Device Regulation help to improve the safety and performance of medical AI devices?

AU - Niemiec, Emilia

N1 - Funding Information: The author disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Forskningsrådet om Hälsa, Arbetsliv och Välfärd (grant no. 2020-01089). Funding Information: I thank Dr Paul Robinson and Dr Aaron James Goldman for their help with language editing. The author disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the Forskningsr?det om H?lsa, Arbetsliv och V?lf?rd (grant no. 2020-01089). Publisher Copyright: © The Author(s) 2022.

PY - 2022

Y1 - 2022

N2 - 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.

AB - 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.

KW - artificial intelligence

KW - Medical device regulation

U2 - 10.1177/20552076221089079

DO - 10.1177/20552076221089079

M3 - Journal article

C2 - 35386955

AN - SCOPUS:85128177007

VL - 8

SP - 1

EP - 8

JO - Digital Health

JF - Digital Health

SN - 2055-2076

ER -