Medical masks without CE marking: the National Health Institute and Confindustria Dispositivi Medici identify the necessary requirements for the placing on the market

The National Health Institute and Confindustria Dispositivi Medici (the Italian Association of Medtech Companies) jointly developed a technical datasheet identifying essential requirements for the placing on the market of surgical masks for medical use not bearing the CE marking pursuant to Article 15 of Decree Law No. 18 of March 17, 2020, so-called Decree "Cura Italia". Indeed, said provision allows manufacturers and importers to place on the market surgical masks and personal protection equipment in derogation from the existing legislation until the end of the state of emergency (i.e. 6 months from January 31, 2020).

With specific regard to surgical masks, the datasheet provides clarifications on how manufacturers and importers of said devices must certify compliance with certain requirements in order to make use of the derogation.

Manufacturers and importers are required to certify and prove, though a self-certification, that the relevant device complies with the efficacy and safety requirements established by Directive 93/42/EEC, implemented in Italy by Legislative Decree No. 46/1997, or, if these requirements are not met, that the same device fulfils the following three minimum requirements to be assessed by the National Health Institute:

  • Compliance with construction, design, performance requirements and test methods for medical face masks intended to limit the transmission of infective agents from staff to patients during surgical procedures and other medical settings with similar requirements, as specified by the technical standard UNI EN 14683:2019 on "Medical face masks - Requirements and test methods", with specific regard to the performance of tests on the filter capacity of the same product. Compliance with performance requirements may provide for two different options in terms of approval depending on whether the mask is intended to (i) healthcare operators or equivalent (public security forces/operators that are in contact with the public) or (ii) workers of companies/citizens;
  • Compliance with biocompatibility requirements applicable to medical devices, as specified by the technical standard UNI EN ISO 10993-1:2010 on "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (harmonized);
  • Adoption and implementation, by the manufacturer, of a quality management system aimed at ensuring and regulating, maintaining and controlling basic requirements related to the production activity.

The National Health Institute published on its website a self-certification form (in Italian) in order to certify the possession of the necessary requirements for the placing on the market in derogation from the in-force regulations.

Export authorisation for personal protective equipment: the European Commission's Implementing Regulation

On March 14, 2020, the European Commission adopted Implementing Regulation (EU) 2020/402 introducing the need for a specific authorization for the export to non-EU countries of certain personal protective equipment, even if not originating in the EU.

Exports of personal protective equipment to EFTA countries (Iceland, Lichtenstein, Norway and Switzerland), to Faeroe Islands, Andorra, San Marino and the Vatican City State and to the overseas countries and territories listed in Annex II to the Treaty on the Functioning of the EU are excluded from the authorization requirement.

In particular, the Regulation provides that the export of protective equipment belonging to the following categories listed in Annex I to the same Regulation is subject to a prior authorization, to be issued by the competent authorities of the Member State where the exporter is established (in Italy, the Ministry of Foreign Affairs and International Cooperation, after consultation with the Civil Protection): (i) protective spectacles and visors, (ii) face shields, (iii) mouth and nose protection devices, (iv) protective garments and (v) gloves.

As regards Italy, authorizations will be issued within 5 working days from the receipt of the relevant request, provided that all necessary conditions are met. However, in the event that the personal protective equipment is located in a Member State other than Italy, the Ministry of Foreign Affairs and International Cooperation shall first acquire the authorization of the concerned Member State, which may grant or deny it within 10 days of the request.

The introduction of said authorisation requirement is part of the measures adopted by the EU to deal with the high demand for essential equipment to prevent the further spread of COVID-19 and to safeguard the health of medical staff treating infected patients and takes into account the fact that, within the EU, the manufacturing of personal protective equipment is currently concentrated in a limited number of Member States (i.e. the Czech Republic, France, Germany and Poland) and that existing stocks may not be sufficient to meet the internal market’s needs.

The Regulation entered into force on March 15, 2020 and shall apply for a period of six weeks from that date.

The European Commission approves the Italian state aid scheme to support the manufacturing and supply of medical equipment and masks for medical use during the coronavirus pandemic

On March 20, 2020, the European Commission approved the Italian aid scheme amounting to euro 50 million to support the manufacturing and supply of medical and personal protective equipment (e.g. ventilators, masks, goggles, gowns and safety suits) to meet the increasing demand due to the COVID-19 emergency while protecting the health of medical staff.

In particular, the European Commission considered the Italian aids scheme as necessary, appropriate and proportionate to remedy the serious disturbance in the Italian economy pursuant to Article 107(3)(b) of the TFEU and the conditions set out in the Temporary Framework for State Aid to support the economy in the context of the COVID-19 outbreak adopted by the European Commission on March 19, 2020.

Specifically, the Italian scheme provides that aids will be granted in the form of direct grants or repayable advances, which can be converted into direct grants if the beneficiary quickly delivers the devices to Italian authorities. Recipients of said aids, which cannot exceed euro 800,000 per individual beneficiary, are companies of any size which (i) set up new facilities for the manufacturing of medical devices and personal protective equipment; (ii) increase the production of their existing facilities manufacturing said devices; or (iii) convert their production line in this sense. Beneficiaries of the State aids will have to sell their products to Italian authorities at market prices applied on December 2019, before the outbreak of the epidemic in Italy.

COVID-19: the European Commission proposes to postpone the deadline for the application of the Medical Devices Regulation

With a communication dated March 25, 2020, the European Commission announced that it is working on a proposal to delay the date of application of the Medical Device Regulation (MDR), currently scheduled for May 26, 2020, by one year. The Commission's aim is to submit the text of the proposal in early April so that the Parliament and the Council can adopt the same before the end of May, before the deadline for the application of the MDR.

The purpose of the above-mentioned proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors and allow them to fully focus on urgent priorities related to the coronavirus crisis.

Currently, the deadline for the application of the In Vitro Diagnostic Medical Devices Regulation, scheduled on May 26, 2022, remains unchanged, although the medtech industry has also requested a postponement for said Regulation.

The Italian Ministry of Health updates the guidelines for SARS-CoV-2 infection laboratory diagnosis

In the light of the spread of SARS-CoV-2 throughout the national territory and according to the recent guidance issued by the European Centre for Disease Prevention and Control concerning laboratory diagnostics, with its circular letter dated March 20, 2020, the Italian Ministry of Health updated the guidelines concerning laboratories’ diagnosis of cases of SARS-CoV-2 infection and the list of laboratories authorized to perform molecular diagnosis on respiratory clinical specimens according to specific Real Time Polymerase Chain Reaction (RT-PCR) protocols for SARS-CoV-2.

In particular, the above-mentioned circular entrusts regional reference laboratories with the task of coordinating and supporting additional laboratories identified by Italian regions to carry out SARS-CoV-2 diagnosis establishing that, for the purpose of assessing the diagnostic capability for COVID-19 infection of these laboratories, it shall be sufficient to confirm the diagnostic results of their first 5 positive and 10 negative specimens with the results obtained by regional reference laboratories.

The circular also provides that where the transmission of COVID-19 is still limited, the diagnosis of positive specimens can be confirmed by the same laboratory performing the SARS-CoV-2 diagnosis through RT-PCR tests whereas, in areas with widespread transmission of COVID-19, the positive RT-PCR test shall be sufficient as laboratory diagnosis. Confirmatory tests should only be performed for specimens whose results are difficult to interpret.

In order to monitor the molecular epidemiology of SARS-CoV-2, the circular also establishes that laboratories must send to the National Reference Laboratory at the Higher Institute of Health only a representative number of clinical specimens. Lastly, it is clarified that, in laboratories authorized for swab analysis, the submission of specimens of medical staff must be given absolute priority and the communication of the result must occur within 36 hours.

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