MDCG guidance clarifies requirements for AI products under AI Act, MDR, and IVDR
Regulatory NewsFerdous Al-Faruque
Artificial intelligence/machine learning (AI/ML)Diagnostics/IVDsDigital health/SaMD/AIEuropeEuropean CommissionGuidanceIn Vitro Diagnostic Medical Devices Regulation (IVDR)Medical DevicesMedical Devices Regulation (MDR)PharmaceuticalsRegulatory Intelligence/Policy