Informative Note

Coronavirus: Exceptional rules for products to prevent the spread of the virus

26/10/2020

In response to the challenges raised by the current Covid-19 pandemic, the Government has introduced exceptional and temporary measures that apply to the manufacture, importation, and placement and availability on the market of medical devices, personal protective equipment, and other products destined to prevent the spread of Covid-19.

The measures adopted are intended to speed up the procedures for assessing compliance with the legal requirements in terms of health, safety and performance, and to establish simplified, exceptional rules for the manufacture of medical devices, personal protective equipment and biocide disinfectant products to prevent the spread of the new Coronavirus.

The purpose of this informative note is to provide information about the changes that apply to the procedures to evaluate medical devices, personal protective equipment and other products intended to prevent the spread of Covid-19.

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