EU publishes regulation governing use of AI in medical devices and IVDs
Regulatory NewsJoanne S. Eglovitch
Artificial intelligence/machine learning (AI/ML)ComplianceConformity AssessmentDiagnostics/IVDsEuropeEuropean CommissionIn Vitro Diagnostic Medical Devices Regulation (IVDR)Medical DevicesMedical Devices Regulation (MDR)Quality Assurance and ControlRegulatory Intelligence/PolicyTechnical documentation