Here we explore the implications of the upcoming EU AI Act for medical devices. The Act establishes a risk-based regulatory framework for AI, with stricter requirements for high-risk applications like medical devices.

The blog outlines key aspects of the Act relevant to medical devices:

• Classification System: The Act classifies AI applications based on risk level (high, medium, low). High-risk medical devices will require stricter compliance measures.

• Transparency Requirements: Manufacturers of medical devices with AI components need to ensure transparency in how these devices arrive at diagnoses or treatment recommendations.

• Human Oversight: The Act emphasizes the importance of human oversight and control over AI-powered medical devices.

SuperAlign: Your Partner in EU AI Act Compliance

The blog highlights how SuperAlign can assist medical device manufacturers in navigating the EU AI Act:

• Compliance Gap Assessment: Identify potential gaps between existing practices and the Act's requirements.

• AI Governance Framework Development: Develop a robust AI governance framework that aligns with the Act's principles.

• Explainable AI for Medical Devices: Implement explainable AI techniques to ensure transparency in device decision-making.

By partnering with SuperAlign, medical device manufacturers can ensure compliance with the EU AI Act and build trust with healthcare professionals and patients.