Clinical evaluation of orphan medical devices From European Commission 🇪🇺 Document focuses on clinical evaluation of orphan medical devices, specifically discussing clinical investigation and evaluation in the context of orphan devices. 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 June 25, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,… 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 June 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Clinical evaluation of medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 This document discusses the clinical evaluation of medical devices, focusing on clinical investigations and performance studies. 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 January 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
GN-20-R2 Guidance on Clinical Evaluation(2022 Nov)_PUB From Health Sciences Authority (HSA) 🇸🇬 Provides guidance on Clinical Evaluation, focusing on regulatory requirements and best practices. 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 November 1, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 4/2021: Equivalence in the clinical evaluation of medical devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing equivalence in the clinical evaluation of medical devices, dated April 2021. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on the clinical evaluation of Software as a Medical Device (SAMD). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 18, 2021 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the consent to prepare for the establishment of the national medical device clinical evaluation standardization technology focal point of the reply letter From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-10001 Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Application Clinical Evaluation Medical Device IVD From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD022 - 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 August 19, 2020 Other (Public Domain) 0 reuses 0 favorites
Guide No. 31 version 2 of 09/07/2020 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Guide to the Clinical Evaluation of Medical Devices 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 July 23, 2020 Other (Public Domain) 0 reuses 0 favorites
Clinical evaluation assessment report template From European Commission 🇪🇺 A template for clinical evaluation assessment reports, covering topics related to clinical investigation and evaluation. 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
Guidance on clinical evaluation – Equivalence From European Commission 🇪🇺 This document provides guidance on clinical evaluation, specifically focusing on the concept of equivalence. 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 consultation procedure exemptions Interpretation of article 54(2)b From European Commission 🇪🇺 This document discusses the interpretation of article 54(2)b and exemptions in the clinical evaluation consultation procedure. 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
Guidance on clinical evaluation (MDR) / Performance evaluation (IVDR) of medical device software From European Commission 🇪🇺 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
Guide No. 31 version 1 of 17/12/2019 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Guide to the Clinical Evaluation of Medical Devices 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 December 30, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical evaluation From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document discussing the process and outcomes of clinical evaluations. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on December 5, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical Evaluation From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF MDCE WG/N56FINAL:2019 (formerly GHTF/SG5/N2R8:2007) 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 October 10, 2019 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SaMD): Clinical Evaluation From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/SaMD WG/N41FINAL:2017 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 September 21, 2017 Other (Public Domain) 0 reuses 0 favorites
Decree no. 2010-270 of March 15, 2010 on the clinical evaluation of medical devices and the communication of identification data to the French Health Products Safety Agency From Ministry of Labor, Health and Solidarity (MTSS) 🇫🇷 Document NOR : SASP1001097D – Décret n° 2010-270 du 15 mars 2010 relatif à l'évaluation clinique des dispositifs médicaux et à la communication des données d'identification à l'Agence française de sécurité sanitaire des produits de santé 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 March 21, 2010 Other (Public Domain) 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) 🇵🇹 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