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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 procedures that the national authorities must follow when considering whether or not: a medical device is unsafe and … See more
Medical devices | European Medicines Agency
- https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- Jan 25, 2023
Guidance - MDCG endorsed documents and other guidance
- https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en
- This page provides a range of documents to assist stakeholders in applying Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 (IVDR) on in …
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, …
European Commission
- 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
- These guidelines describe the European system for the notification and evaluation of INCIDENTs and FIELD SAFETY CORRECTIVE ACTIONS (FSCA) involving MEDICAL …
Vigilance Reporting Requirements …
- https://www.qualitymeddev.com/2021/02/25/vigilance-reporting/
- Obviously, the vigilance reporting process is highly linked to the process of compliant handling; having a strong system for the management of customer …
EU MDR Vigilance Reporting and MEDDEV …
- https://www.orielstat.com/blog/eu-mdr-ivdr-vigilance-reporting-requirements/
- MEDDEV 2.12-1 Rev 8 was published in January 2013 and provides guidance to medical device manufacturers on market surveillance. It continues to …
EU Medical Device Vigilance Reporting in Europe - Emergo
- https://www.emergobyul.com/services/medical-device-vigilance-and-incident-reporting-europe
- What is medical device vigilance and adverse event reporting? The vigilance requirements in the Medical Device Regulation (MDR) No. 2017/745 (for medical devices or active …
Key Terms and Concepts in the Medical Device Regulation
- https://mdss.com/key-terms-and-concepts-in-the-medical-device-regulation-vigilance/
- To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and concepts in Chapter VII of the …
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