Towards regulatory compliant lifecycle for AI-based medical devices in EU: Industry perspectives

TL;DR

This paper discusses extending the EU regulatory framework to better address AI-specific safety considerations in AI-powered medical devices, proposing a model to ensure compliance throughout their lifecycle.

Contribution

It introduces a novel model that integrates AI lifecycle management with regulatory activities tailored for AI-enabled medical devices in the EU.

Findings

Proposes a comprehensive AI lifecycle model for medical devices

Identifies gaps in current EU regulations for AI-specific safety

Suggests regulatory activities aligned with AI development stages

Abstract

Despite the immense potential of AI-powered medical devices to revolutionize healthcare, concerns regarding their safety in life-critical applications remain. While the European regulatory framework provides a comprehensive approach to medical device software development, it falls short in addressing AI-specific considerations. This article proposes a model to bridge this gap by extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems.