Combined studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document covers various studies, focusing on clinical trials. 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Performance studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses performance studies, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical investigations, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Announcements From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Various announcements on clinical trials, clinical investigation etc. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 From European Commission 🇪🇺 Document covers Q&A on practical aspects of implementing extended transitional period in the IVDR, as amended by Regulation (EU) 2024/1860. 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 July 9, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDR/IVDR forms From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document containing forms related to Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). 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 24, 2024 Other (Public Domain) 0 reuses 0 favorites
Preliminary re-assessment review (PRAR) form template (IVDR) From European Commission 🇪🇺 A template for the Preliminary Re-assessment Review (PRAR) form under the IVDR. 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 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Preliminary assessment review (PAR) form template (IVDR) From European Commission 🇪🇺 A template for Preliminary Assessment Review (PAR) form under the IVDR. 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 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
The European Medical Device Nomenclature (EMDN) From Ministry of Health (Italy) (MDS) 🇮🇹 Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the functioning of 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 December 1, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) From European Commission 🇪🇺 This document provides guidance on the role of a 'person responsible for regulatory compliance' in medical device and in vitro diagnostic device regulations. 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
Notification of IVDs From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Notification of IVDs for 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 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Performance assessment according to IVDR From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A document outlining the process and criteria for evaluating performance in compliance with the In Vitro Diagnostic Regulation (IVDR). 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 20, 2023 Other (Public Domain) 0 reuses 0 favorites
MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR and IVDR requirements From European Commission 🇪🇺 A position paper urging manufacturers to comply with MDR and IVDR requirements in a timely manner. 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 30, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Clinical trials From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
MDR Newsletter 1/2022: MDR and IVDR harmonised standards From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing harmonised standards for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the 1/2022 edition. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
MDR/IVDR Newsletter 8/2022: MDR and IVDR harmonised standards II. From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing harmonised standards for Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in the 8/2022 edition. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
MDR/IVDR Newsletter 7/2022: Application dates of the IVDR Regulation From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the application dates of the IVDR Regulation in the 7/2022 edition. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
MDR/IVDR Newsletter 12/2022: The IVDR performance assessment process From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the performance assessment process of the In Vitro Diagnostic Regulation (IVDR) in the December 2022 edition. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
MDR/IVDR Newsletter 10/2022: Basics about IVD devices in the light of the IVDR or what devices I need to register as an IVD distributor From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the basics of in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Regulation (IVDR) and registration requirements for IVD 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Evaluation procedures for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 As of May 26, 2022, Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council, repealing Directive 98/79/EC and Commission Decision 2010/227/EU, is applicable with some exceptions. On September 28, 2022, Legislative Decree No. 138 of August 5, 2022 on the adaptation of national… 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 20, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites