EU Commission MDR/IVDR includes changes to medical device software classification, AI Act delay
Regulatory NewsFerdous Al-Faruque
Artificial intelligence/machine learning (AI/ML)Combination products/companion diagnosticsDiagnostics/IVDsDigital health/SaMD/AIEuropeEuropean CommissionIn Vitro Diagnostic Medical Devices Regulation (IVDR)Medical DevicesMedical Devices Regulation (MDR)Regulatory Intelligence/Policy