As highlighted by the European document "Manual on Borderline and Classification in the Community Regulatory Framework for medical devices”, air purifiers and sanitizers cannot bear the CE marking as medical devices, as they are not considered such.
At a national level, this concept was taken up and clarified in Circular from the Ministry of Health of 11 June 2021. The Ministry points out that these products cannot be considered medical devices, because they are aimed at sanitizing, sanitizing, purifying the air of environments, not to direct contact with the patient.
To date, manufacturing companies that have incorrectly marked these products have the obligation to delete them from the medical device database and to clearly update the typology of associated marking.
THE REGULATORY FRAMEWORK
Among the main references we find the aforementioned European guide "Manual on Borderline and Classification in the Community Regulatory Framework for medical devices” version 1.22 (05-2019) which analyzes the issue in two specific sections – points 1.13 and 1.23. The paragraph “1.13 – Air purifiers/Air decontamination units/Mobile air decontamination units” explains that afor a product to be considered a medical device, “the device in question must have a direct association with the individual patient”.
The document introduces a further level of analysis, highlighting that ensuring clean air actually contributes to keeping a patient in an appropriate environment. It concludes by underlining that “air is part of the patient's environment and its cleaning is necessary in a similar way to what happens for surfaces, walls, floors and other objects that need to be cleaned and disinfected. Since these products do not meet the definition of a medical device, they are not considered to be medical devices, but rather are products for the general environment.”
The point "1.23. UV flow germicidal lamp” confirms that - while noting the importance of clean and healthy air for patients - also the UV flow germicidal lampsdo not meet the definition of a medical device or the definition of medical device accessory and therefore must not be classified as such".
Although it does not specifically concern the issue, finally, also the Regulation (EU) 2017/745 (MDR), in application from 26 May 2021, has explicitly included in the scope of application only products intended for cleaning, disinfection and sterilization of medical devices.
In light of this regulatory reworking, the products used for sanitizing, sanitizing and purifying air will be able to be introduced on the market on the basis of general safety provisions of the products placed on the market, possibly presenting the CE marking pursuant to other European Union harmonization acts.
SANCTIONS FOR IMPROPER MARKINGS
By examining various regulatory sources including Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 relating to medical devices, it is highlighted that the manufacturers or theirs agents, The healthcare workers, i legal representatives of healthcare facilities that violate the requirements relating to the CE marking of devices may be punished with various ranges of financial penalties.
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