Masks, disinfectants, and serological tests: regulatory issues relating to products to be used in phases 2 and 3 of the emergency period
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After the lockdown, for correct management of phases 2 and 3, products such as masks and disinfectants become even more essential in containing and preventing the spread of COVID-19. Moreover, although the efficacy of serological testing is still controversial, it is becoming an increasingly important tool for monitoring the spread of COVID-19 in the national territory, especially as the population begins to move around more following the reopening of regional borders.

1. Masks

Different types of masks are marketed. From a regulatory point of view, masks can be classified as medical devices (“MD”) or personal protective equipment (dispositivi di protezione individuale – “DPI”) depending on their features (e.g., surgical masks are MD while FFP2 and FFP3 masks are classified as DPI).

There is also a third category of masks (not classifiable as MD or DPI) regulated by article 16(2) of the Cura Italia Decree (Legislative Decree No. 18/2020).[1] Such masks are not subject to CE marking or any validation procedure; they can be used by the population, including workers, when the minimum distance of 1 meter between people can be maintained, but not in hospital or care environments. The production of this type of masks is allowed only until the end of the state of emergency (i.e., July 31, 2020).

Masks classified as both MD and DPI can be used without CE marking up to the end of the emergency period (article 5-bis of the Cura Italia Decree).

Indeed, the emergency legislation introduced a validation procedure in derogation of the current provisions that allows the sale of surgical masks and DPI without CE marking and simplifies the ordinary validation procedure. Specifically, the Cura Italia Decree (article 15) provides a mechanism based on (i) self-certification issued by the manufacturer, importer, or person who places the product on the market and (ii) subsequent evaluation by the Istituto Superiore di Sanità (“ISS”) for surgical masks or the Istituto Nazionale per l’Assicurazione contro gli Infortuni sul Lavoro (“INAIL”) for DPI. An opinion (in favor or not) regarding the marketing of these products must be issued by the ISS or INAIL within three days of transmission of self-certification.

Moreover, in order to simplify the importation of surgical masks, as well as FFP2 and FFP3 filter face masks, the Italian Ministry of Health, with the Ordinance of April 26, 2020, established that the fact that a label is written in one of the languages of the European Union other than Italian does not constitute an impediment to issuing health clearance for the importation of such products.

2. Disinfectant products

Many products available on the market claim to have disinfectant power, but what does that mean and how do they differ from detergents with sanitizing power?

Only products authorized as biocides or medical surgical devices may claim disinfectant, antibacterial, and sanitizing powers on their labels. To be authorized as such, these products must contain active ingredients capable of eliminating bacteria and harmful organisms. In particular, their sale is subject to prior authorization from the Ministry of Health (or the European Commission, in the case of biocides). Moreover, the number of the authorization must be indicated on the label. Otherwise, the product cannot claim disinfectant and antibacterial properties specific to biocides (or medical surgical devices). Under certain conditions, criminal sanctions may also be applied (e.g., in case of fraud in the trade under article 515 of the Italian criminal code).

Detergents differ from biocides and medical surgical products, in that they are not subject to the authorization of the Ministry of Health and can only claim sanitizing properties, while they may not claim that they remove germs and bacteria or have disinfectant or antiseptic properties.

With a view to the prevention and management of the epidemiological emergency stemming from COVID-2019 and to speed up the placement of biocidal products on the market, the Ministry of Health, in a note dated May 22, 2020 on sanitization procedures, recommended the use of authorized biocides that contain certain specific active ingredients that should be effective against COVID-19; in addition, the Ministry of Health has also provided the possibility for manufacturers to apply for temporary authorization valid for a maximum of 180 days (Ministry of Health Communication of April 6, 2020) to place such products on the market.

3. Serological tests

Serological tests detect antibodies in the blood produced by a patient’s body in response to infection with the virus SARS-CoV-2 (i.e., IgM and IgG antibodies). Consequently, such tests detect whether the patient came into contact with the virus. Serological tests are mainly useful in the epidemiological evaluation of circulation of COVID-19 within national borders. According to a note issued by the Ministry of Health on May 9, 2020, tests cannot be used as a substitute diagnostic tool for molecular testing based on the identification of viral RNA from nasopharyngeal swabs (RT-PCR).

Indeed, as highlighted by the World Health Organization and the Ministry of Health, serological tests may generate false or negative results. Therefore, any positive result provided by the test must be confirmed by a molecular test.

With a circular dated May 9, 2020, the Ministry of Health strongly recommended, among the different types of serological tests available, the use of quantitative tests[2] such as CLIA and/or ELISA with a specificity of no less than 95% and a sensitivity of no less than 90%. Serological tests are not self-diagnostic tests, so they are intended for professional use only.

From a regulatory point of view, serological tests are in vitro diagnostic medical devices that require CE marking, applied under the oversight of the manufacturer. In particular, the manufacturer must certify, by means of a declaration of compliance, that the requirements of Directive 98/79/EC[3] are met; validation by notified bodies is not required.[4]

In consideration of the above, the European Commission recommended carrying out additional validation of the clinical performance of tests for COVID-19 by comparison with a reference method in a sufficiently large number of target population subjects before introducing the devices into the clinical routine.[5]

Accordingly, the public tender issued by the extraordinary commissioner for the epidemiological emergency to acquire kits, reagents, and consumables for the performance of 150,000 serological tests[6] set as a condition to bid that the test kits (of the CLIA and/or ELISA type) had received validation from qualified laboratories or regulatory agencies operating at the national or international level.

On May 25, the survey of the seroprevalence of infection of SARS-CoV-2 virus started.[7] The survey involves the execution of serological tests on a sample of 150,000 people and is being conducted by the Ministry of Health and Istat, in collaboration with the Italian Red Cross. The data will be used for epidemiological purposes to assess the actual spread of COVID-19 among the Italian population.

[1] The Cura Italia Decree was converted with amendments into law by Law No. 27 of April 24, 2020.

[2] Quantitative serological tests can measure the amount of antibodies in the blood. They are performed on venous blood (by sampling). Quantitative tests are different from qualitative serological tests that only indicate the presence or absence of antibodies in the blood and are performed on capillary blood.

[3] Directive 98/79/EC of the European Parliament and of the Council of October 27, 1998 on in vitro diagnostic medical devices.

[4] However, the “Simplified and urgent tender for the acquisition of kits, reagents and consumables for the performance of 150,000 serological tests aimed at a sample survey on the spread of sars-cov-2 infection” (published on April 17, 2020 and expired on April 22) required test kits of the CLIA and/or ELISA type to be subject to validation by qualified laboratories or regulatory agencies operating at the national or international level.

[5] Communication from the Commission Guidelines on COVID-19 in vitro diagnostic tests and their performance 2020/C 122 I/01, published in the EU Official Journal on April 15, 2020.

[6] “Simplified and urgent tender for the acquisition of kits, reagents and consumables for the performance of 150,000 serological tests aimed at a sample survey on the spread of sars-cov-2 infection” (published on April 17, 2020).

[7] Such measures concerning epidemiological and statistical studies on SARS-COV-2 are regulated by Law Decree No. 30 of May 10, 2020.

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