As highlighted by the European document "Manual on Borderline and Classification in the Community Regulatory Framework for medical devices”, air purifiers and sanitizers cannot have the CE marking as medical devices, since they are not considered as such.
Nationally, this concept was taken up and clarified in the Circular of 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 sanitation, sanitation, air purification of the rooms, not in direct contact with the patient.
To manufacturing companies that have incorrectly marked these products, to date, it is the obligation of delete them from the database of medical devices and to update, clearly, the type 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) than in two specific sections - the points 1.13 and 1.23 – takes the question into analysis. The paragraph "1.13 – Air purifiers/Air decontamination units/Mobile air decontamination units"Explains that aas long as a product is 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 emphasizing that "the 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 items that need to be cleaned and disinfected. As these products do not meet the definition of a medical device, they are not considered to be medical devices, but they are rather products for the environment in general ".
The point "1.23. UV flow germicidal lamp” confirms that - while noting the importance of clean and healthy air for patients – anche le UV germicidal lamps "do not meet the definition of a medical device o the definition of medical device accessory and therefore must not be qualified as such ".
While not specifically addressing the issue, finally, also the Regulations (EU) 2017/745 (MDR), in application since 26 May 2021 has explicitly included in the scope of application only products intended for cleaning, disinfection and sterilization of medical devices.
In the face of this legislative reworking, the products used for sanitation, sanitation and air purification can be introduced on the market based on the general safety provisions of 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 the Regulation (EU) 2017/745 the European Parliament and of the Council, the 5 April 2017, relating to medical devices, it is pointed out that i fabbricanti o i loro agent, gli health workers, the legal representatives health facilities that violate the provisions relating to the CE marking of devices may be punished with various ranges of pecuniary sanctions.
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