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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The proposed EU AI Act has been challenged by industry in recent years, but views expressed during a panel discussion at the MedTech Forum 2023 point towards increasing support among medtech stakeholders for the landmark legislation.
The European Commission’s proposed Artificial Intelligence Act is now set to enter high-level negotiations after MEPs voted overwhelmingly in favor of the draft text in a plenary vote.
The text of the European Commission’s proposed AI Act is expected to enter the EU high-level negotiation stage within weeks, yet many questions remain as to what the final regulation will entail. Lawyers from Cooley LLP tell Medtech Insight why considerable changes to the text are possible, and what the new law is likely to mean for medtech.