Medical Device Vigilance Guidelines

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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 reports are submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients,...

Medical Device Cybersecurity: What You Need to Know

https://www.fda.gov/consumers/consumer-updates/medical-device-cybersecurity-what-you-need-know

Protect your device and personal information: Use good password practices for your device. Create a unique password and do not share it with others. Keep your …

Do you know the requirements and your …

https://www.bsigroup.com/meddev/LocalFiles/en-US/Whitepapers/bsi-md-whitepaper-vigilance.pdf

Medical devices are regulated differently across the globe. Each country/region has mandated the requirements around what medical devices are, their …

Vigilance Reporting Requirements according to EU MDR …

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

MDCG 2023-3 Questions and Answers on vigilance terms …

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

This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a …

Market surveillance and vigilance - Public Health

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

The enforcement of the harmonised legislation on medical devices is the responsibility of the authorities in EU countries. The Medical Devices Directives establish specific …

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 …

European Commission | Choose your language | Choisir …

https://ec.europa.eu/docsroom/documents/32301

{"listableLinks":null,"documentId":32301,"title":"Guidance document - Market surveillance - Guidelines on a Medical Devices Vigilance System - MEDDEV 2.12/1 rev.8 ...

EUROPEAN COMMISSION DG Health and …

http://meddev.info/_documents/2_12_1_rev8.pdf

INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL DEVICEs, known as the Medical Device Vigilance System. The principal purpose of the …

Medical Device Vigilance System

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

It is the manufacturer’s or the EAR’s obligation that they should notify the Competent Authority in case of any deterioration in the characteristics and performance of the …

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