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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...

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Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
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• By Ashley Yeo

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From ‘Work Harder’ to ‘Phenomenal People’: Makary’s FDA About-Face

 
• By Michael McCaughan

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Time For Medtech To Have Its Say On Critical Changes In EU Framework Legislation

 
• By Amanda Maxwell

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