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.
EU AI Act Legal Deep-Dive Part 2: Balancing Medtech Innovation With Safety
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.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.
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The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.
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Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.
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Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.
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A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.