EUDAMED – User guides and templates From European Commission 🇪🇺 This document provides user guides and templates for EUDAMED, a system for medical device registration and monitoring in the EU. 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Legacy devices From Ministry of Health (Italy) (MDS) 🇮🇹 Regulation (EU) 2017/745, for medical devices, and Regulation (EU) 2017/746, for in vitro diagnostic medical devices, allow CE-marked devices under the previous directives to remain on the market in some particular cases. 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 February 28, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1 From European Commission 🇪🇺 This document is an addendum to the MDCG Position Paper on the application of Article 97 MDR to legacy devices with expired certificates. 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
Application for certificates for free sale (IVDD medical devices, up classified and legacy devices) From Health Products Regulatory Authority (HPRA) 🇮🇪 A form for applying for certificates for free sale of IVDD medical devices, including up classified and legacy 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 December 20, 2022 Other (Public Domain) 0 reuses 0 favorites
MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate From European Commission 🇪🇺 This document discusses the application of Article 97 MDR to legacy devices with expired MDD or AIMDD certificates. 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
Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC From European Commission 🇪🇺 Regulation (EU) 2017/746 applies IVDR requirements to 'legacy devices' and devices placed on the market before 26 May 2022. 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
MDR Newsletter 25/2021: Legacy device newsletter Part 2 From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter for Medical Device Regulation (MDR) with updates on legacy devices in Part 2 of the series, dated 2021. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 21/2021: Frequently asked questions and technical details for the transition to MDR - Part III (What is not a legacy device - for manufacturers and distributors) From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing frequently asked questions and technical details for transitioning to MDR, focusing on what is not a legacy device for manufacturers and distributors. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Application of MDR requirements to "legacy devices" and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC From European Commission 🇪🇺 This document discusses the application of MDR requirements to legacy devices and devices placed on the market before May 26, 2021. 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
Application for certificates for free sale (MDD medical devices system and procedure packs legacy devices) From Health Products Regulatory Authority (HPRA) 🇮🇪 A form for applying for certificates for free sale related to MDD medical devices system and procedure packs legacy 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 May 27, 2021 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 9/2020: Legacy device newsletter 1. From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter for September 2020 focusing on legacy devices. 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 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance on sufficient clinical evidence for legacy devices From European Commission 🇪🇺 This document provides guidance on obtaining sufficient clinical evidence for legacy devices, 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
Registration of legacy devices in EUDAMED From European Commission 🇪🇺 This document discusses the registration process for legacy devices in EUDAMED, a topic of interest. 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