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Industry Welcomes Changes To EU AI Act, But Fears Of Overlap Remain

 
• By Eliza Slawther

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

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