In the context of the COVID-19 pandemic, great attention is given to the sanitation measures of people and environments.
People use surgical masks, protective personal equipment (PPE) masks or surgical gloves, and the environments are sanitized with dedicated products and equipment.
The category of products used for sanitizing environments includes air purifiers and air sanitizers. These products, from a regulatory standpoint, are not medical devices.
However, many companies classified air sanitizer and air purifiers as medical devices, affixing the CE mark on the products.
The Italian Ministry of Health (MoH) issued an official note specifying that air purifiers and air sanitizers cannot be considered Medical Devices as they lack a real medical purpose. This aspect has also been confirmed at European level in the “Manual on Borderline and Classification in the Community Regulatory Framework for medical devices “.
The MoH with this official note warned companies to classify air purifiers as Medical Devices and to market them as such; the MoH has also ordered companies to remove these products from the national database of medical devices.
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