Review of incidents and vigilance investigations involving medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Reference document Review of incidents and vigilance investigations of medical devices in your approach 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Users From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ This document is about users and focuses on reporting incidents and FSCAs (vigilance). 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 June 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Incident reporting by patients From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last update: November 10, 2020 Medical device incident reporting Medical device vigilance system: incident reporting by patients and users What is a Medical Device? What is the Medical Device Vigilance System? What can I report? Who can report? How can I report? How can I report? 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Incident reporting by companies From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last update: November 23, 2021 Included are the notification forms for the Guidelines on the Medical Device Vigilance System that can be completed and submitted by email to psvigilancia@aemps.es or by fax to +34918225289 Notification Form. Incident Report of 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 June 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidelines for the implementation of the vigilance system by health care facilities and professionals From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last updated: 03 June 2019 Guidelines for the implementation of the surveillance system by healthcare facilities and professionals. Ref: AEMPS/CTI-PS/May 2019. How to report incidents. Notification of incidents involving medical devices. How to record the delivery of the product involved in theโฆ 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Report an adverse event or incident From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information on how to report an adverse event or drug reaction for medicines, biologicals and 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 June 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Economic operators From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about economic operators and their role in reporting incidents and FSCAs (vigilance). 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 June 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Device Incident Reporting (MDIR) guide From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance document updated to include final report and additional information requirements following amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 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
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview From Health Canada ๐จ๐ฆ Summary of guidance for hospitals about achieving compliance with federal regulatory requirement to report serious ADRs and MDIs to Health Canada. 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 18, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
MORE Submissions - user reference guide From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง A step-by-step guide on using the MORE Platform for Submissions of device related incidents. 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 August 24, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
MORE Registrations - user reference guide From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents. 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 August 24, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Report a medical device incident - for sponsors and manufacturers From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Industry portal - Log in to report medical device incidents via the Medical Device Incident Reporting (MDIR) system. 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 12, 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
Reporting medical device adverse incidents From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Reporting medical device adverse incidents 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 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reporting adverse incidents involving Software as a Medical Device under the vigilance system From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable. 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 15, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Incident reporting for medical devices: Guidance document From Health Canada ๐จ๐ฆ Guidance document for incident reporting 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 April 17, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Database of Adverse Event Notifications (DAEN) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Provides information about adverse events and incidents related to therapeutic goods used in Australia. 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 Other (Non-Commercial) 0 reuses 0 favorites
Medical device incident reporting & investigation scheme (IRIS) articles From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Read publications about the Medical device incident reporting & investigation scheme (IRIS) articles. 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 5, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Serious adverse drug reactions and medical device incidents - Canada.ca From Health Canada ๐จ๐ฆ A summary of serious adverse drug reactions and medical device incidents reported by hospitals and tracked in the Canada Vigilance database. 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 15, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance for manufacturers on medical device incident reporting From Danish Medicines Agency (DKMA) ๐ฉ๐ฐ A document providing guidance for manufacturers on reporting incidents related to 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 May 21, 2021 Other (Public Domain) 0 reuses 0 favorites