Principle 15: Principles applying to IVD medical devices only From Therapeutic Goods Administration (TGA) π¦πΊ Principle 15 covers elements that apply to IVD medical devices. Manufacturers should hold evidence of performance evaluation studies to meet the requirements. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices From European Commission πͺπΊ Guidance on evaluating COVID-19 diagnostic devices, focusing on SARS-CoV-2 performance. Important for in vitro testing. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
GHTF Study Group 5 - Clinical Safety/Performance From International Medical Device Regulators Forum (IMDRF) π GHTF Study Group 5 - Clinical Safety/Performance documents Metadata quality: Metadata quality: Data description empty Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on November 2, 2012 Other (Public Domain) 0 reuses 0 favorites
Handling of Performance Evaluation Tests of Diagnostic Medical Devices Using Existing Medical Image Data without Involvement of Additional Invasiveness or Intervention From Pharmaceuticals and Medical Devices Agency (PMDA) π―π΅ PSEHB/MDED Notification No.0929-1 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on September 29, 2021 Other (Public Domain) 0 reuses 0 favorites
Frequently asked questions: Performance evaluation of point-of-care COVID-19 serology antibody test kits From South African Health Products Regulatory Authority (SAHPRA) πΏπ¦ Document Number MD024 - Version 1 Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on September 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software From European Commission πͺπΊ Guidance on clinical evaluation and performance evaluation of medical device software, with a focus on new technologies. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Clinical evaluation of medical devices / Performance evaluation and clinical evidence of in-vitro medical devices From National Authority of Medicines and Health Products (Infarmed) π΅πΉ Entities menu, medical devices area, access to the area of clinical evaluation of medical devices (DM) / evaluation of the functional behavior of diagnostic devices in vitro (DIV) Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 77.77777777777779/100 Updated on November 30, 2023 Other (Public Domain) 0 reuses 0 favorites