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
On 5 September, the European Parliament's Legal Affairs (JURI) Committee on human oversight