Integrated Analytical Framework for the Development of Artificial Intelligence-Based Medical Devices.

Area of Science:

• Medical Device Regulation
• Artificial Intelligence in Healthcare
• International Harmonization

Background:

• Applying artificial intelligence (AI) to medical devices faces challenges in balancing high performance with safety and reliability.
• International regulations for medical devices and AI implementations vary significantly, creating complex compliance landscapes.

Purpose of the Study:

• To address the challenges in regulating AI-based medical devices globally.
• To examine universal legal, ethical, and regulatory requirements for AI medical devices across different countries.
• To propose an integrated framework for analyzing and comparing these requirements.

Main Methods:

• Comparative analysis of legal and ethical issues, and regulatory requirements in international guidances for AI-based medical devices.
• Development of an integrated framework for comprehensive analysis and comparison of AI medical device requirements.

Main Results:

• No single international guidance completely covers all necessary evaluation requirements for AI medical devices.
• Discrepancies in regulatory coverage across countries highlight the need for international harmonization.
• The proposed framework facilitates a comprehensive comparison of AI medical device requirements.

Conclusions:

• Manufacturers can choose between adhering to diverse local regulations or adopting a universal compliance strategy using the integrated framework.
• The universal compliance approach is recommended for enhanced efficiency and convergence in the development of AI medical devices.
• International harmonization efforts are crucial for streamlining the regulatory process for AI-enabled medical technologies.