Medtech products, including those with artificial intelligence (AI) components, are subject to rules set out by the EU Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR). But the EU’s proposed AI Act could add another layer of regulation for companies that make AI-enabled medical devices and diagnostics.
Industry Welcomes Changes To EU AI Act, But Fears Of Overlap Remain
While recently proposed amendments to the draft EU legislation on Artificial Intelligence are a step in the right direction for medical devices, trade associations MedTech Europe and COCIR warn that the potential for regulatory conflicts remains.
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