Artificial Intelligence-Enabled Medical Device Standards: A Multidisciplinary Literature Review

Abstract

Concern has been noted at the lack of international standards available for Artificial Intelligence-enabled Medical Device (AIeMD) development, evaluation, and monitoring. This multidisciplinary literature review provides an overview of the current standards in development in support of the EU Artificial Intelligence (AI) Act. The EU AI Act requires that high-risk AI is regulated, though notably with an absence of regulatory guidance within healthcare to date. The medical device industry has already released hundreds of AIeMDs on the global market. This research is therefore necessary to provide the much-needed awareness of current and forthcoming standards. This research demonstrates that technical guidance is available to industry and requires consideration where it represents the current State of the Art (SoTA)