EU Artificial Intelligence Act

The EU AI Act (Artificial Intelligence Act Regulation EU 2024/1689), which came into force on 1 August 2024, establishes a harmonised framework for regulating AI systems. It impacts the use of AI in medical settings, particularly when integrated with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The convergence of artificial intelligence and pharmaceutical innovation is no longer a distant vision; it’s today’s reality. With a projected market size of $116.49 billion by the end of 2025 and a 27% compound annual growth rate (CAGR), AI in pharma is reshaping everything from drug discovery to diagnostics.

In 2025, manufacturers of AI-powered medical devices face a new regulatory reality. The European Union has introduced the Artificial Intelligence Act (AIA). If your device falls under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR), the AIA is mandatory. It’s now a core part of your compliance strategy.

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