EU and US Regulatory Challenges Facing AI Health Care Innovator Firms
Bill of Health
APRIL 4, 2024
Although the cross-sectoral AI legislation that is now introduced by the European Commission’s Digital Strategy aims to be integrated with existing sectoral legislation such as the MDR, the IVDR and the Machinery Directive, it is uncertain how overlapping regulatory compliance requirements for AI-driven medical devices will be managed in practice.
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