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

Tuomas Granlund, Vlad Stirbu, Tommi Mikkonen

TL;DR

This article proposes extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems to address concerns regarding their safety in life-critical applications.

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.

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

TL;DR

This article proposes extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems to address concerns regarding their safety in life-critical applications.

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.
Paper Structure (12 sections, 3 figures)

This paper contains 12 sections, 3 figures.

Table of Contents

  1. THE EU REGULATORY FRAMEWORK
  2. MEDICAL SOFTWARE PRODUCT DEVELOPMENT
  3. Design controls
  4. From plan-driven to continuous engineering
  5. Regulatory Operations -- RegOps
  6. REGULATORY CHALLENGES OF MEDICAL AI SYSTEMS
  7. Regulatory landscape for medical AI systems
  8. Other legislation
  9. Design control challenges of AI-based systems
  10. TOWARDS COMPLIANT LIFECYCLE MODEL FOR MEDICAL AI SYSTEMS
  11. Building on state-of-the-art and established processes
  12. Lifecycle stages

Figures (3)

  • Figure 1: The regulatory landscape in the medical domain illustrated.
  • Figure 2: System and software development design control activities Stirbu2023.
  • Figure 3: Lifecycle model for medical device products including AI technology, adapted from ISO/IEC 5338:2023