Vigilance system


Vigilance system

European Directives and future Regulation 2017/745 on Medical Devices require the implementation of a vigilance system to identify possible incidents and report them to the Competent Authorities.

The vigilance system according to MDR 2017/745 must be implemented by all medical device manufacturers from 26 May 2020 (date of application of the Regulation); this also applies to medical devices with a CE certificate issued in accordance with the Directives and still valid after 26 May 2020.

Whether you are based in Europe, or in any part of the world, Merc will support you with the development and implementation of a vigilance system as well as in the reporting activity (when is needed, how to report and at whom).

Merc also offers a vigilance and complaints management service for small and medium-sized organizations, handling all activities according to national and European regulations and guidelines.

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Vigilance system