Air purifiers and sanitizers are not medical devices

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 and purifying the air in environments, not at 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 which analyzes the issue in two specific sections - points 1.13 and 1.23. Paragraph 1.13 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 lamps do 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.

PROCEDURAL UPDATES

In light of this regulatory reworking, products used for sanitization, hygiene and air purification may be introduced onto the market on the basis of the general provisions on the safety of products placed on the market, possibly presenting the CE marking pursuant to other European Union harmonization acts.

SANCTIONS FOR IMPROPER MARKINGS

Taking into consideration various regulatory sources including Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, it is highlighted that manufacturers or their agents, healthcare professionals, legal representatives of healthcare facilities who violate the provisions relating to the CE marking of devices may be punished with various ranges of financial penalties.