Medical Devices Vigilance

Medical Device Reporting (MDR): How to Report Medical …

https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

Medical Device Reporting (MDR) is one of the postmarket surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues, and contribute to...

MDCG 2023-3 Questions and Answers on vigilance terms …

https://health.ec.europa.eu/system/files/2023-02/mdcg_2023-3_en_0.pdf

Medical Devices Vigilance System1 with, where relevant, modifications for alignment with the MDR. The term ‘devices’ will be understood to include medical devices, accessories …

New European MDCG Guidance on Medical Device Vigilance …

https://www.emergobyul.com/news/new-european-mdcg-guidance-medical-device-vigilance-requirements

The long-awaited Medical Device Coordination Group (MDCG) Guidance on Vigilance has been published to the European Commission website. MDCG 2023-3, …

Market surveillance and vigilance - Public Health

https://health.ec.europa.eu/medical-devices-sector/directives/market-surveillance-and-vigilance_en

Medical Device Pharmacovigilance | Pharmacovigilance

https://allaboutpharmacovigilance.org/pharmacovigilance-guidance-material/medical-device-pharmacovigilance/

Medical device Pharmacovigilance is the monitoring of safety profile of medical devices, from the processing and reporting of single adverse incidents through to the removal of …

Key Terms and Concepts in the Medical Device Regulation

https://mdss.com/key-terms-and-concepts-in-the-medical-device-regulation-vigilance/

The vigilance requirements under the EU’s medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device …

Vigilance Reporting Requirements according to EU MDR …

https://www.qualitymeddev.com/2021/02/25/vigilance-reporting/

According to the new EU MDR, events directly involving a medical device are considered reportable under the following circumstances: The event caused or might cause a serious public health …

Medical Device Vigilance

https://www.makrocare.com/devices/pms/vigilance/

Medical device vigilance, as known as materiovigilance, is the collection, assessment, reporting and identification of trends in incidents resulting from the use of medical …

MDCG 2023-3: EU MDR Vigilance Terms & Concepts - Casus …

https://casusconsulting.com/mdcg-2023-3-mdr-vigilance/

MDCG 2023-3: Q&A on MDR Vigilance Terms and Concepts. The MDCG released a new guidance document on vigilance terms and concepts under the EU MDR …

Medical Device Vigilance System & Procedure

https://www.i3cglobal.com/medical-device-vigilance-system/

Medical Device Vigilance System Vigilance means to be watchful of the possible danger or difficulties. The Medical Device Vigilance System is designed to collect information on post-market incidents or adverse …