Economic Operator Registration RequirementsEU ManufacturerNon-EU ManufacturerImporterEU Manufacturer EU Manufacturer Create Economic Operator ProcedureSection description goes here Economic Operator Procedure, EU Manufacturer – $250 $250.00 + Create EUDAMED Registration ProcedureSection description goes here Initial Registration, EUDAMED for EU Manufacturers – $250 $250.00 + Identify Administrators / Job DescriptionsSection description goes here Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR – $150 $150.00 + Create Procedure for EUDAMED Product RegistrationSection description goes here Create Basic UDI for product familiesSection description goes here Basic UDI-DI procedure-MDR – $250 $250.00 + UDI Implementation Plan Template-MDR – $150 $150.00 + UDI User Guide – $0 $0.00 + UDI-DI procedure-MDR – $250 $250.00 + Identify Person(s) responsible for Regulatory ComplianceSection description goes here Non-EU Manufacturer Non-EU Manufacturer Ensure contract in place with Authorized RepSection description goes here Create Economic Operator ProcedureSection description goes here Economic Operator Procedure, Non-EU Manufacturer – $250 $250.00 + Create EUDAMED Registration ProcedureSection description goes here Initial Registration, EUDAMED for NON-EU Manufacturers – $250 $250.00 + Create Procedure for EUDAMED Product RegistrationSection description goes here Create Basic UDI for product familiesSection description goes here Basic UDI-DI procedure-MDR – $250 $250.00 + UDI Implementation Plan Template-MDR – $150 $150.00 + UDI User Guide – $0 $0.00 + UDI-DI procedure-MDR – $250 $250.00 + Identify Administrators / Job DescriptionsSection description goes here Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR – $150 $150.00 + Identify Person(s) responsible for Regulatory ComplianceSection description goes here Importer Importer Economic Operator ProcedureSection description goes here Economic Operator Procedure, Importer – $250 $250.00 + EUDAMED Registration ProcedureSection description goes here Initial Registration, EUDAMED for EU Importers – $250 $250.00 + Identify Administrators / Job DescriptionsSection description goes here Job Descriptions/Competency with PRRC and EUDAMED roles define-MDR – $150 $150.00 +
