Face masks: medical devices, PPE or filters for the public? A little clarity…

Written on 30 Apr 2020

In order to deal with the Coronavirus emergency, the Italian ‘Cura Italia’ Decree (d.l. 18/2020) has also adopted extraordinary measures relating to surgical masks and personal protective equipment that permit the production, import and marketing in derogation from the established rules, and therefore without the CE marks.

The Decree also contains the possibility to use other types of "filtering masks" for the benefit of the community as a whole, which are neither medical devices (MD) nor personal protective equipment (PPE). All measures contained in the Decree are valid until the end of the state of emergency, which has been set - for the moment – as 31 July 2020.

The result is that as present  there are different types of face masks on the market and some clarification is welcome to identify exactly what they are and when they can be used.

 

Surgical masks with CE mark

These masks are for medical use, with the aim of avoiding the wearer contaminating the environment around him, as they limit the outward transmission of infective agents.

They are medical devices (MD), bearing the CE mark, and are still subject to the provisions of Legislative Decree n. 46/1997 (the entry into force of  EU Regulation 2017/745 on medical devices has been postponed to May 2021).

The relevant technical specifications for their production are contained in UNI EN 14683:2019.

It is possible to use surgical masks as PPE to protect healthcare workers (art. 34, paragraph 3, law decree 9/2020).

In addition, surgical masks are also considered as PPE for those workers who are objectively unable to maintain the social distancing limit of at least 1 meter  (art. 16, paragraph 1, of the ‘Cura Italia’ Decree).

By order  n. 11/20 dated 26 April 2020 issued by the Extraordinary Coronavirus Commissioner, the price to the public of surgical masks has been set at Euro 0.50, plus VAT.

Masks with CE mark (FFP2 and FFP3)

These are the facial filters (FFP2 and FFP3) for individual protection, used in hospitals and care homes in order to protect the user from external agents (and from the transmission of infection by droplets and aerosol).

They are PPE for the purposes of Legislative Decree 475/1992 - which by means of Legislative Decree 17/2019 has been brought into line with EU Regulation  425/2016 on PPE – and, as such, must be subject to the CE marking.

They must comply with the harmonised technical rules contained in UNI EN 149:2009 and are divided into various classes of FFP (filtering face piece) protection according to their filtering capacity.

Surgical masks without any CE mark

These are surgical masks, and therefore MDs, that are produced,  imported,  and placed on sale  in derogation of the applicable regulations – and therefore which do not bear the CE mark – subject however to the favourable opinion of the Istituto Superiore di Sanità (ISS), the main centre for research, control and technical-scientific advice on public health in Italy.

A simplified extraordinary validation procedure is provided, whereby the proposing party must send a self-certification to the ISS in which, under its sole responsibility, it certifies the technical characteristics of the masks and declares that they comply with all the safety requirements contained the current legislation, and provide any element useful for their validation. Within the following 3 days, the ISS will issue its decisions on the compliance or otherwise of the surgical masks with the current regulations (art. 15, paragraph 2, ‘Cura Italia’ Decree).

Filtering masks without any CE mark  

These are PPEs that are produced, imported and placed on sale in derogation from the applicable regulations and therefore which do not bear the CE mark – subject however to the favourable opinion of INAIL.

A specific and extraordinary validation procedure is provided, similar to that for surgical masks, where the competent body is however INAIL.

Generic filtering masks

These are neither MDs, nor PPE, but are filtering masks without any CE marking, produced in derogation of the applicable rules for the placing on sale, that can be produced pursuant to art. 16, paragraph 2, of the ‘Cura Italia’ Decree.

The Ministry of Health has clarified that art.16 allows “all individuals present on the national territory, who are however required to comply with the provisions on social distancing and the other precautionary rules introduced due to the Covid-19 emergency, to use, as a precautionary measure, filter masks that given their use are not considered as MDs or PPE "(Circular n. 3572/2020).

These masks are not subject to any simplified validation and authorization procedure of the ISS and are not required to comply with any particular harmonized UNI EN - ISO technical standards.

They can be produced under the responsibility of the manufacturer who must still guarantee the safety of the product.

Furthermore, they cannot be used by health workers when on duty or by other workers who are required to use specific PPE.

It should be emphasized that, although there are no regulatory requirements, correct information must be given to users on the nature and methods of use of these masks, also in line with the Code of Consumers.