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.

Doctor Scanning MRIs
• Source: Shutterstock

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 representatives, such as trade body MedTech Europe, have long voiced concerns about the potential negative impact of the AI Act on medtech products. The AI Act draft...

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