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DPI, telematic transmission activated for validation waivers

As of 13 May, a new method of telematic transmission is active on the website of the National Institute for Insurance against Accidents at Work (INAIL) for applications of extraordinary validation, notwithstanding the current legislation, for personal protective equipment (PPE), as provided for by law decree no. 18/2020 for the management of the COVID-19 emergency.

In fact, following Recommendation EU 2020/403 of the European Commission, granting Members States the possibility to authorise the marketing of PPEs without CE marking, Italy has provided for that INAIL can act as assessor of authorisation procedures notwithstanding the current legislation.

This is a new competence for the Institute, exceptionally attributed notwithstanding the usual procedures until the end of the state of emergency determined by the pandemic. When the emergency is over, it will be possible to continue the manufacturing, importation and marketing of these PPEs only by obtaining the CE marking according to the standard procedures.

The waiver – it should be stressed – does not concern the quality of the products, that shall ensure an adequate level of health and safety for users (as specified by the same EU Regulation); it rather refers to the procedure itself and to accelerated timetables. It should be borne in mind, among other things, that such waiver only applies to PPEs that are ‘functional to mitigation of risks related to the health emergency’: goggles, splash goggles, shields, filtering half-masks, half-masks and other masks, total masks, protective clothing and disposable gloves.

These devices are all regulated by specific UNI EN norms; in particular, personal protection masks, used for the protection from droplets and aerosols, should be made based on the UNI EN 149:2009 (‘Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking’) or international regulations, whose equivalence the applicant is able to demonstrate. Moreover, all PPEs should be clearly identifiable by their trade name, model and manufacturer.

On this regard, it should be reminded that the marketing and use of masks with no CE marking is also allowed only for precaution, i.e. that are not classified either as medical devices (MD) or personal protection equipment (PPE). The validation procedures notwithstanding the regulations in force do not apply to this type of masks, as they do not ensure any type of protection against external agents, and therefore they cannot be used by health professionals and other categories of workers for whom the use of specific devices is not provided for. However, the provisions of the Ministry of Health provides for that the manufacturer ensures that these masks do not cause any damage or determine any additional risks for the users’ health.

Regulations only provide for that the manufacturer ensures that surgical masks do not cause any damage or determine any additional risks for the users according to the expected intended use.

The possibility to transmit telematically the PPE extraordinary validation applications can perhaps ensure greater availability of these products on the market, to protect professional figures needing them to work in full safety. The service is accessible through the registration in the Institute website, that also made available a self-certification facsimile where the requested documents should be attached. A series of FAQs is also available, clarifying the methods of the procedure and the documentation required.