EUDAMED โ Topics per Actor From European Commission ๐ช๐บ This document provides an overview of topics related to EUDAMED system categorized by different actors involved in the process. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Focus campaigns From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Document titled "Focus campaigns" focusing on the topic of "Market surveillance". 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 February 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission ๐ช๐บ Get answers to questions about Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 regarding authorised representatives, importers, and distributors. 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, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Swiss authorised representative (CH-REP) From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about the Swiss authorised representative (CH-REP) and how it facilitates market access. 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 November 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Obligations for authorised representatives, importers and distributors From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about the obligations for authorised representatives, importers, and distributors in relation to market access. 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 November 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitroโฆ 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 July 3, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Agreement between an organization representing multiple legal manufacturers and an authorized representative form. 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 February 16, 2023 Other (Public Domain) 0 reuses 0 favorites
Agreement between a single legal manufacturer and an authorized representative From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Agreement between a legal manufacturer and an authorized representative form. 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 February 16, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission ๐ช๐บ Get guidance on the regulations for Authorised Representatives, Importers, and Distributors in the EU (Regulation (EU) 2017/745 and 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
GHTF Study Group 1 - Pre-market Evaluation From International Medical Device Regulators Forum (IMDRF) ๐ GHTF Study Group 1 - Pre-market Evaluation 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
Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers subject to the obligations of Article 31 MDR and Article 28 IVDR From European Commission ๐ช๐บ This document provides information on the registration obligations in EUDAMED for actors other than manufacturers, authorized representatives, and importers. 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
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices From European Commission ๐ช๐บ 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
Guidance on Requirements of Medical Devices Quality Management System for Distributors, Importers and Authorized Representatives From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ QMS requirements for distributors, importers, and authorized representatives of 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 May 1, 2019 Other (Public Domain) 0 reuses 0 favorites