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EU AI Act Legal Deep-Dive Part 2: Balancing Medtech Innovation With Safety

 
• By Eliza Slawther

The EU AI Act could introduce rigorous regulatory requirements for AI-based medical devices in addition to those contained in the MDR/IVDR. Lawyers from Cooley LLP tell Medtech Insight how changes to the commission’s proposal could improve its impact on medtech while keeping patients safe.

AI Legislation
• Source: Shutterstock

Tomorrow (14 June), the European Commission’s landmark AI Act proposal is scheduled to undergo a plenary vote by members of the European Parliament, which could see the draft text move into the final high-level negotiation phase, known as trilogue discussions.

In an article published last week, expert lawyers at Cooley explained what the AI Act means for medtech, why the legislation remains uncertain, and when it might apply

Why Is The AI Act So Controversial?

As a horizontal regulation, the AI Act covers all sectors and uses of AI systems. In particular, EU political groups have been divided on issues such as the issue of using biometric identification such as facial recognition technology in public spaces.

Many of the AI Act’s most contentious and hotly debated provisions do not directly apply to medical device manufacturers

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