The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices From European Commission 🇪🇺 This document discusses the status of IMDRF N48 Appendixes E-I under the EU regulatory framework for medical devices, focusing on the Unique Device Identifier (UDI). 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
FAQ on the European Medical Device Nomenclature (EMDN) From European Commission 🇪🇺 Get answers to frequently asked questions about the European Medical Device Nomenclature (EMDN). 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 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Medical Device Regulation comes into application From European Medicines Agency (EMA) 🇪🇺 Information on implementation of the Medical Device Regulation. 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 May 26, 2021 Other (Public Domain) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed) From European Parliament 🇪🇺 This document is an implementing regulation that establishes rules for the European Database on Medical Devices (Eudamed). 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 May 25, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices From European Commission 🇪🇺 Notice to manufacturers and authorised representatives on the impact of genetic variants on COVID-19 diagnostic 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers From European Commission 🇪🇺 This document is a MDCG position paper on implementing UDI requirements for contact lenses, spectacle frames, spectacle lenses, and ready readers. 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 Implant Card – Device types From European Commission 🇪🇺 This document provides guidance on implant cards and different types of devices. 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 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functional From European Commission 🇪🇺 This document provides guidance on administrative practices and technical solutions related to EUDAMED until it is fully functional. 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 investigation application/notification documents From European Commission 🇪🇺 This document is about clinical investigation application/notification documents, focusing on 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
Factsheet for Manufacturers of Implantable Medical Devices From European Commission 🇪🇺 Factsheet for Manufacturers of Implantable Medical Devices 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 January 31, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Factsheet for Class I - Medical Devices From European Commission 🇪🇺 Factsheet for Class I - Medical Devices 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 January 31, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices From European Parliament 🇪🇺 Draft implementing regulation laying down rules for the application of Regulation (EU) 2017/745 on electronic instructions for use of medical devices. 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 April 27, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS From European Parliament 🇪🇺 A proposal for a regulation on artificial intelligence, aiming to establish harmonized rules and amend existing legislative acts in the European Union. 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 April 21, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/611 of 14 April 2021 amending Implementing Decision (EU) 2020/438 as regards harmonised standards on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2021/611 amends Implementing Decision (EU) 2020/438 on harmonised standards for medical devices and clinical investigations. 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 April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/610 of 14 April 2021 amending Implementing Decision (EU) 2020/437 as regards harmonised standards on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electroacoustics and medical electrical equipment From European Parliament 🇪🇺 Amendment to Implementing Decision (EU) 2020/437 on harmonised standards for medical vehicles, equipment, and devices. 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 April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Implementing Decision (EU) 2021/609 of 14 April 2021 amending Implementing Decision (EU) 2020/439 as regards harmonised standards on packaging for terminally sterilised medical devices and sterilisation of health care products From European Parliament 🇪🇺 Commission Implementing Decision (EU) 2021/609 amends standards on packaging for sterilised medical devices and sterilisation of healthcare products. 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 April 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on basic UDI-DI and changes to UDI-DI From European Commission 🇪🇺 Get guidance on basic UDI-DI and changes to UDI-DI, focusing on the Unique Device Identifier (UDI). 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 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 From European Commission 🇪🇺 This document discusses the application of transitional provisions for certifying class D in vitro diagnostic medical devices under Regulation (EU) 2017/746. 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
Consultation procedure for ancillary medicinal substances in medical devices From European Medicines Agency (EMA) 🇪🇺 Guidelines for consultation process on ancillary medicinal substances in 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 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Infographic - Is your software a Medical Device? From European Commission 🇪🇺 Infographic - Is your software a Medical Device? 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 December 1, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites