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Respiratory protection in the time of covid-19: ppes, mds and the latest developments in the national regulatory framework

The most used personal protection equipment (PPE) for respiratory protection is filtrating masks. These are usually bound to meet the requirements of the technical norm EN 149:2001 and Annex A1:2009 Respiratory protection devices – Filtering half-masks against particles — Requirements, testing, marketing“.

These products ensures protection against particles and are used for the purposes of prevention and protection against harmful biologic agents as viruses. Being PPEs, this type of device falls into the field of application of Regulation (EU) 2016/425

On the other hand, surgical masks are class I medical devices, usually designed according to the norm EN 14683:2005 Medical face masks – Requirements and test methods”. They allow the protection of nose and mouth from contamination with particles with a mean diameter of 4.5 µm. These products fall into the field of application of Directive 93/42/EEC and Regulation (EU) 2017/745.

At the current state of the art, the CE marking is required for both devices. Moreover, the manufacturer is also bound to follow a specific procedure to assess their conformity.

However, in order to face the COVID19 emergency, by the Law Decree of 17 March 2020 no. 18, “Measures for the reinforcement of the National Health System and for the economic support for families, workers and enterprises related to the epidemiologic emergency due to COVID-19” the Italian government has given final instructions in order to allow the manufacturing, importation and marketing of surgical masks and personal protection equipment notwithstanding the provisions in force. The decree allows to streamline and speed up the conformity assessment procedures of these product, although not undermining their quality standards.

In particular, manufacturers and importers of surgical masks and those marketing them can submit a self-certification to the Italian Higher Health Institute (ISS), where they shall certify, under their own responsibility, the technical characteristics of the product and state that these complies with al safety requirements as per the current regulations.

Manufacturing companies and importers shall transmit to the ISS any element that could be useful for the validation of the concerned surgical masks no later than 3 days from the above self-certification. The ISS, within 3 days from the reception of the above documents, will express their opinion on the compliance of the surgical masks with the current regulations.

On the other hand, for the masks classified as PPEs, manufacturers, importers and those who market them, in order to enjoy the waiver from the provisions of Regulation (EU) 2016/425, can follow a process that is very similar to that of surgical masks. In this case, however, the reference body is the National Institute for Prevention against Work-related Injuries (INAIL).

Di Renzo Regulatory Affairs has been constantly following the evolution of these norms and is in continuous contact with the bodies responsible for the product technical assessment. This allows our company to assist with competence and precision anyone wishing to avail themselves of our services.

Written by: Antonio Ciriello e Riccardo del Signore