MDCG provides guidance on qualifying breakthrough devices
Regulatory NewsJoanne S. Eglovitch
Audit/inspectionBreakthrough devices programCE MarkClinical outcome assessmentComplianceDiagnostics/IVDsEuropeEuropean CommissionIn Vitro Diagnostic Medical Devices Regulation (IVDR)Medical DevicesMedical Devices Regulation (MDR)Performance evaluationRegulatory Intelligence/Policy