The white paper explores the regulatory challenges posed by AI-integrated medical devices in the EU. It focuses on the EU’s proposed Artificial Intelligence Act, which classifies AI systems by risk—medical device AI falls under high-risk, triggering strict compliance, transparency, and oversight requirements. Key issues include managing ‘black box’ AI models, aligning with the GDPR, and ensuring robust cybersecurity and human oversight. The paper also covers upcoming EU and UK regulatory shifts, evolving liability regimes, and global developments. Manufacturers must navigate overlapping legal frameworks while maintaining innovation and safety.

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