On June 11, 2021, the Italian Ministry of Health published an open letter to address the classification issue of air purifiers and air decontamination units.
It was clarified that these products do not have a medical intended purpose, as they do not directly operate on patients – they are instead used to ’control the environment’ and remove possible allergens or air contaminants.
This interpretation is also underpinned by the EU Manual on Borderline and Classification in the Community Regulatory Framework for medical devices (2019), which clarifies in section 1.13 that products for the purification and decontamination of air do not fall under the definition of medical devices. They are instead “products for the general environment”. The guideline explains that, while preserving clean air might help keep patients in a safe environment, this must be kept clean and disinfected in the same way as surfaces, walls and floors do. Moreover, for a product to be classified as a medical device, it must have a direct association with the individual patient (EC, 2019).
Similarly, germicidal UV lamps (described in chapter 1.23 of the same Manual) do not have a medical scope. The authorities also state that according to the definition under Regulation (EU) 2017/745 MDR only those “products specifically intended for the cleaning, disinfection or sterilization” of devices covered by the Regulation itself are included under its scope. The position of the Italian Ministry is therefore in line with the European Union legislative framework.
In conclusion, the Health Ministry finally requests manufacturers who had previously CE marked these goods as medical devices not to classify them as such, and to deregister the same products from the Italian database of medical devices.
Tancredi Vergani
Regulatory Affairs Department
19/08/2021
Are you a manufacturer in need of help to determine which piece of legislation covers your products in the EU? With more than 30 years of experience, Obelis provides borderline classification services to correctly launch your European project and turn it into a success! Contact us today.
References:
European Commission (2019). Manual on Borderline Classification in the Community Regulatory Framework for Medical Devices, Version 1.22 (05-2019). Retrieved on 19 August 2021 from https://ec.europa.eu/docsroom/documents/35582
Ministero della Salute (11 June 2021). DGDMF.3/P/I.1.b.f.1/2020/128 – OGGETTO: Prodotti impiegati per la sanificazione, l’igienizzazione e la purificazione dell’aria degli ambienti. Retrieved on 18 August 2021 from