IMDRF | Technical documents
-
Annex_A_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting_-_Medical_Device_Problem.xlsx
-
Annex_B_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting_-_Type_of_Investigation.xlsx
-
Annex_C_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting__Investigation_Findings.xlsx
-
Annex_D_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting_-_Investigation_Conclusion.xlsx
-
Annex_E_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting_-_Health_Effects.xlsx
-
Annex_F_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting_-_Health_Effects.xlsx
-
Annex_G_IMDRF_terminologies_for_categorized_Adverse_Event_Reporting_-_Medical_Device_Component.xlsx
-
Assembly_and_Technical_Guide_for_IMDRF_Table_of_Contents_Submissions.docx
-
Assembly_and_Technical_Guide_for_IMDRF_Table_of_Contents_Submissions.pdf
-
Clinical_Evaluation.docx
-
Clinical_Evaluation.pdf
-
Clinical_Evidence_-_Key_Definitions_and_Concepts.docx
-
Clinical_Evidence_-_Key_Definitions_and_Concepts.pdf
-
Clinical_Investigation.docx
-
Clinical_Investigation.pdf
-
Common_Data_Elements_for_Medical_Device_Identification.docx
-
Common_Data_Elements_for_Medical_Device_Identification.pdf
-
Competence_and_Training_Requirements_for_Auditing_Organizations.docx
-
Competence_and_Training_Requirements_for_Auditing_Organizations.pdf
-
Competence__Training__and_Conduct_Requirements_for_Regulatory_Reviewers.docx
-
Competence__Training__and_Conduct_Requirements_for_Regulatory_Reviewers.pdf
-
Definitions_for_Personalized_Medical_Devices.docx
-
Definitions_for_Personalized_Medical_Devices.pdf
-
Essential_Principles_of_Safety_and_Performance_of_Medical_Devices_and_IVD_Medical_Devices.docx
-
Essential_Principles_of_Safety_and_Performance_of_Medical_Devices_and_IVD_Medical_Devices.pdf
-
imdrf-proc-ivd-template.zip
-
imdrf-proc-nivd-template.zip
-
In_Vitro_Diagnostic_Medical_Device_Market_Authorization_Table_of_Contents.docx
-
In_Vitro_Diagnostic_Medical_Device_Market_Authorization_Table_of_Contents.pdf
-
MDSAP_Assessment_and_Decision_Process_for_the_Recognition_of_an_Auditing_Organization.docx
-
MDSAP_Assessment_and_Decision_Process_for_the_Recognition_of_an_Auditing_Organization.pdf
-
Medical_Devices_Post-Market_Surveillance_National_Competent_Authority_Report_Exchange_Criteria_and_Report_Form.docx
-
Medical_Devices_Post-Market_Surveillance_National_Competent_Authority_Report_Exchange_Criteria_and_Report_Form.pdf
-
Medical_Devices_Post_Market_Surveillance_National_Competent_Authority_Report_Exchange_Criteria_and_Report_Form.docx
-
Medical_Devices_Post_Market_Surveillance_National_Competent_Authority_Report_Exchange_Criteria_and_Report_Form.pdf
-
Medical_Device_Regulatory_Audit_Reports.docx
-
Medical_Device_Regulatory_Audit_Reports.pdf
-
Methodological_Principles_in_the_Use_of_International_Medical_Device_Registry_Data.docx
-
Methodological_Principles_in_the_Use_of_International_Medical_Device_Registry_Data.pdf
-
Non-In_Vitro_Diagnostic_Device_Market_Authorization_Table_of_Contents.docx
-
Non-In_Vitro_Diagnostic_Device_Market_Authorization_Table_of_Contents.pdf
-
Optimizing_Standards_for_Regulatory_Use.docx
-
Optimizing_Standards_for_Regulatory_Use.pdf
-
Personalized_Medical_Devices_-_Regulatory_Pathways.docx
-
Personalized_Medical_Devices_-_Regulatory_Pathways.pdf
-
Principles_and_Practices_for_Medical_Device_Cybersecurity.docx
-
Principles_and_Practices_for_Medical_Device_Cybersecurity.pdf
-
Principles_of_International_System_of_Registries_Linked_to_Other_Data_Sources_and_Tools.docx
-
Principles_of_International_System_of_Registries_Linked_to_Other_Data_Sources_and_Tools.pdf
-
Principles_of_Labelling_for_Medical_Devices_and_IVD_Medical_Devices.docx
-
Principles_of_Labelling_for_Medical_Devices_and_IVD_Medical_Devices.pdf
-
Regulatory_Authority_Assessor_Competence_and_Training_Requirements.docx
-
Regulatory_Authority_Assessor_Competence_and_Training_Requirements.pdf
-
Requirements_for_Medical_Device_Auditing_Organizations_for_Regulatory_Authority_Recognition.docx
-
Requirements_for_Medical_Device_Auditing_Organizations_for_Regulatory_Authority_Recognition.pdf
-
Requirements_for_Regulatory_Authority_Recognition_of_Conformity_Assessment_Bodies.docx
-
Requirements_for_Regulatory_Authority_Recognition_of_Conformity_Assessment_Bodies.pdf
-
Software_as_a_Medical_Device_Possible_Framework_for_Risk_Categorization_and_Corresponding_Considerations.docx
-
Software_as_a_Medical_Device_Possible_Framework_for_Risk_Categorization_and_Corresponding_Considerations.pdf
-
Software_as_a_Medical_Device_SaMD_Key_Definitions.docx
-
Software_as_a_Medical_Device_SaMD_Key_Definitions.pdf
-
Software_as_a_Medical_Device__SaMD__Application_of_Quality_Management_System.docx
-
Software_as_a_Medical_Device__SaMD__Application_of_Quality_Management_System.pdf
-
Software_as_a_Medical_Device__SaMD__Clinical_Evaluation.docx
-
Software_as_a_Medical_Device__SaMD__Clinical_Evaluation.pdf
-
Terminologies_for_Categorized_Adverse_Event_Reporting__AER__terms__terminology_and_codes.docx
-
Terminologies_for_Categorized_Adverse_Event_Reporting__AER__terms__terminology_and_codes.pdf
-
Tools_for_Assessing_the_Usability_of_Registries_in_Support_of_Regulatory_Decision-Making.docx
-
Tools_for_Assessing_the_Usability_of_Registries_in_Support_of_Regulatory_Decision-Making.pdf
-
UDI_Guidance_Unique_Device_Identification_UDI_of_Medical_Devices.docx
-
UDI_Guidance_Unique_Device_Identification_UDI_of_Medical_Devices.pdf
-
Unique_Device_Identification_system__UDI_system__Application_Guide.docx
-
Unique_Device_Identification_system__UDI_system__Application_Guide.pdf