Vigilance Reporting For Medical Devices

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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 for Manufacturers - Guidance for Industry and Food and Drug Administration Staff FDA Guidance: Medical Device Reporting for User Facilities (PDF Only) (PDF - 313KB) For...

Vigilance Reporting Requirements according to EU MDR 2017/745

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

Responsibilities for medical device vigilance …

https://www.bsigroup.com/en-US/medical-devices/resources/Whitepapers-and-articles/responsibilities-for-medical-device-vigilance-reporting/

This paper outlines the requirements specific to incident reporting, vigilance, mandatory problem reporting, medical device reports and adverse event reporting, …

Vigilance Reporting and Post-Market …

https://www.bsigroup.com/en-US/medical-devices/resources/Whitepapers-and-articles/vigilance-reporting-pms/

This paper addresses a number of areas, including PMS as an element of the management of clinical evidence throughout the device lifecycle; the PMS system, which is …

Vigilance Reporting Under the MDR: Insider's Guide

https://www.linkedin.com/pulse/vigilance-reporting-under-mdr-insiders-guide-ethan-drower

A medical device event is reportable if: It caused or might cause a serious public health threat It caused death or serious deterioration of health of the patient, user, …

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, …

EU MDR Vigilance Reporting and MEDDEV …

https://www.orielstat.com/blog/eu-mdr-ivdr-vigilance-reporting-requirements/

Important: Since the new EU MDR will become mandatory for all postmarket activities beginning May 26, 2021, medical device manufacturers need to …

MDR Chapter VII Section 2-VIGILANCE. Clarifications …

https://www.linkedin.com/pulse/mdr-chapter-vii-section-2-vigilance-clarifications-terms-

Art 87 1(a) Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities: (a) …

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

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

A ‘Periodic summary report’ (PSR) is an alternative reporting process. This allows a manufacturer, in agreement with the respective national competent authority that …

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