Ce Medical Device Vigilance Guidelines

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Medical Devices Regulation applies since 26 May 2021. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active …

Market surveillance and vigilance - Public Health

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

Vigilance Reporting Requirements according to EU MDR …

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 complaints is surely helpful to properly fulfil the …

Guidance on the vigilance system for CE-marked …

https://ec.europa.eu/docsroom/documents/32305/attachments/8/translations/en/renditions/pdf

Introduction Device Specific Vigilance Guidance documents have been developed to complement the requirements of the Medical Devices Directive [1] and the MEDDEV [2], …