Announcement on the European Commission's investigation into the electronic instructions for use of Medical Devices From National Organization for Medicines (EOF) 🇬🇷 To see the announcement, click 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 (Public Domain) 0 reuses 0 favorites
Electronic Instructions for Use (eIFU) From Therapeutic Goods Administration (TGA) 🇦🇺 For manufacturers of medical devices considering supplying the instructions for use of their device in an electronic or online format. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 830 of 06/12/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on December 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 810 of 17/08/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Amends Collegiate Board Resolution - RDC No. 751, of September 15, 2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on August 18, 2023 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 777 of 01/03/2023 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Amends Collegiate Board Resolution - RDC No. 751, of September 15, 2022, which provides for risk classification, notification and registration regimes, and labeling requirements and instructions for use of medical devices. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on March 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Information for patients: A guide to antigen self-testing for COVID-19 From Health Canada 🇨🇦 Self-testing allows people to test themselves or their dependants for SARS-CoV-2, the virus that causes COVID-19. These tests provide a snapshot of your current infection status. This guide should be read in addition to the instructions for use that are provided with the test. 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 16, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Registering medical devices in the national database From Ministry of Health (Italy) (MDS) 🇮🇹 The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the… 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
Collegiate Board Resolution - RDC No. 751 of 15/09/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use of medical devices. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on September 21, 2022 Other (Public Domain) 0 reuses 0 favorites
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 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 🇪🇺 Commission Implementing Regulation (EU) 2021/2226 provides 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 December 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on labeling and instructions for use for medical devices From Danish Medicines Agency (DKMA) 🇩🇰 A document providing guidance on labeling and instructions for use for medical 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 October 18, 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 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
User Instruction for Medical Products (Laser Notice 44) From Food and Drug Administration (FDA) 🇺🇸 A guidance document titled "User Instruction for Medical Products (Laser Notice 44)" provides instructions for using medical products. 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 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Normative Instruction - IN no. 3 of 26/08/2015 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Regulates item I of art. 20 of Resolution of the Collegiate Board of Directors-RDC no. 36, of August 26, 2015, which provides for risk classification, registration and registration control regimes and labeling requirements and instructions for use of in vitro diagnostic products, including their… Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on August 26, 2015 Other (Public Domain) 0 reuses 0 favorites
The Medical Devices (Amendment) Regulations 2013 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations amend the Medical Devices Regulation 2002 (the 2002 Regulations) in order to implement Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices and Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular… 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 September 12, 2013 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Electronic instructions for use of medical devices: guidance on regulations From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance for medical device manufacturers on when electronic instructions for use can be used. 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 14, 2013 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Text with EEA relevance From European Parliament 🇪🇺 Commission Regulation (EU) No. 207/2012 on electronic instructions for use of medical devices. EEA relevant. 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 9, 2012 Creative Commons Attribution 4.0 0 reuses 0 favorites
Order of April 20, 2006 specifying the form and dimensions of the CE marking that must be affixed to medical devices before they are placed on the market, as well as to their commercial packaging and instructions for use From Ministry of Labor, Health and Solidarity (MTSS) 🇫🇷 Document NOR : SANP0621716A – Arrêté du 20 avril 2006 précisant la forme et les dimensions du marquage CE devant être apposé sur les dispositifs médicaux avant leur mise sur le marché ainsi que sur leurs emballages commerciaux et leurs notices d'utilisation 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 20, 2006 Other (Public Domain) 0 reuses 0 favorites
Order of November 9, 2004 specifying the form and dimensions of the CE marking to be affixed to in vitro diagnostic medical devices before they are placed on the market, as well as to their commercial packaging and instructions for use From Ministry of Labor, Health and Solidarity (MTSS) 🇫🇷 Document NOR : SANP0423934A – Arrêté du 9 novembre 2004 précisant la forme et les dimensions du marquage CE devant être apposé sur les dispositifs médicaux de diagnostic in vitro avant leur mise sur le marché ainsi que sur leurs emballages commerciaux et leurs notices d'utilisation 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 9, 2004 Other (Public Domain) 0 reuses 0 favorites