Termination of extraordinary validation of surgical masks
Given the Decree Law of 22 April 2021, n. 52, converted, with modifications, by the law of 17 June 2021, n. 87, containing “Urgent measures for the gradual resumption of economic and social activities in compliance with the need to contain the spread of the COVID-19 epidemic”, published in the Gazzetta Ufficiale no. 146 of 21 June 2021, has ordered, in article 11 of the converted Decree Law, the extension of the terms provided for by the legislative provisions listed in annex 2, in which the reference to article 15, paragraph 1, of the decree has been deleted -law 17 March 2020, n. 18, converted, with amendments, by Law 24 April 2020, n. 27, present in the original text of annex 2 to the Decree Law of 22 April 2021, n. 52. In light of the legislative change that has taken place, which no longer provides for article 15 of the Decree-law of 17 March 2020, n. 18 among the legislative provisions extended to 31 July 2021, with effect from 18 June 2021, the extraordinary validation function and by way of derogation of facial masks for medical use attributed to the Istituto Superiore di Sanità by paragraph 2 of the same article 15 ceased and, therefore the related CE marking service for manufacturers of is no longer active.
Following the entry into force of the Legislative Decree n. 34 of May 19, 2020 on "Provisions for the simplification of procedures for the import and validation of surgical masks and personal protective equipment", converted with amendments by Law no. 77 of 17 July 2020, the validation procedure in derogation, originally provided for by art. 15 of the D.L. n. 18 of March 17, 2020, has been amended, providing for a new procedure for proponents who import and market facial masks for medical use. According to art. 66 bis of Legislative Decree no. 34/2020 (converted by Law n°.77/2020), a Technical Committee chaired by a representative of the Institute, has been established, to define simplified validation criteria that will be applied by the Regions to assess the applications submitted, by way of derogation, for the importation and marketing of facial masks for medical use. The simplified criteria were sent to the Regions with a note dated 11/23/2020 and can be found for convenience in the Annexes section below. For this reason starting from 09/02/2021 all assessment applications for importation and marketing of facial masks for medical use are suspended. However, ISS remains competent, pursuant to art. 15 paragraph 2 of the D.L. n. 18 of March 17, 2020, amended by Law no. 77 of 17 July 2020, for the extraordinary validation activities regarding manufacturing and subsequent marketing authorization of facial masks for medical use.
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