{"id":14197,"date":"2020-04-08T15:49:19","date_gmt":"2020-04-08T13:49:19","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=14197"},"modified":"2020-04-08T15:49:19","modified_gmt":"2020-04-08T13:49:19","slug":"covid-19-in-italy-emergency-supply-of-medical-devices-and-personal-protective-equipment","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/04\/08\/covid-19-in-italy-emergency-supply-of-medical-devices-and-personal-protective-equipment\/","title":{"rendered":"COVID-19: in Italy emergency supply of medical devices and personal protective equipment"},"content":{"rendered":"\n<p>The <strong>Covid-19<\/strong> medical emergency has led to the <strong>necessity to find medical devices and personal protective equipment (PPE)<\/strong>. In response to this, with 17 March 2020 <strong>Law<\/strong> <strong>Decree no. 18 (articles 15 and 16)<\/strong>,<strong> <\/strong>the Italian Government has specified different types of derogation procedures to allow the production of surgical masks and personal protective equipment. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/04\/covid-19-emergenza-fornitura-dm-dpi-1024x535.png\" alt=\"covid-19 emergency supply of medical devices and personal protective equipment\" class=\"wp-image-14152\"\/><figcaption>COVID-19: emergency supply of medical devices and personal protective equipment<\/figcaption><\/figure>\n\n\n\n<p>The derogation to the ordinary certification\nprocedure for medical devices only concerns the timeframe and not the product\nquality and technical standards.<\/p>\n\n\n\n<p>The Italian National Institute of Health (ISS) has created the \u201cCOVID-19 medical devices work group\u201d which is in charge of evaluating the use of medical masks without CE marking notwithstanding the ordinary certification procedure and only for this emergency period.<br>Furthermore, the <strong>ISS <\/strong>has published an updated document on PEE indications for use.<\/p>\n\n\n\n<p>To produce surgical masks the companies must send to the ISS a self-certification in which they describe, under their own responsibility, the technical characteristics of the masks. The companies have to declare that the masks meet all safety requirements. <br>No later than 3 days after the self-certification, the manufacturers must send to the ISS any element that can be useful for the validation of the masks.<br>The masks must meet the following requirements:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>They\nmust correspond to both <strong>UNI EN ISO 14683<\/strong> and <strong>UNI EN ISO 10993 <\/strong>regulations;<\/li><li>They\nmust be produced by companies that have a <strong>Quality\nSystem<\/strong> <\/li><\/ul>\n\n\n\n<p>These requirements\nare also valid for the production of \u201cnon-woven fabric\u201d masks.<\/p>\n\n\n\n<p>To produce PPE items (including FFP2 and FFP3 masks) the manufacturers wanting to use the derogation, must send a self-certification to the Italian National Institute for Occupational Safety (INAIL). In this document, &nbsp;they must confirm, under their own responsibility, the technical characteristics of the abovementioned devices and declare that they meet all the safety requirements. In particular, <strong>FFP2 <\/strong>and<strong> FFP3 <\/strong>masks should be certified according to Law Decree no. 475\/1992 and in compliance with <strong>UNI EN 149:2009<\/strong> regulation.<\/p>\n\n\n\n<p>Whenever, according to the ISS and\/or INAIL\nevaluation, <strong>the products do not comply\nwith the regulations<\/strong>, the <strong>Manufacturer\nmust immediately stop their production and the Importer must not place them on\nthe market<\/strong>. &nbsp;<\/p>\n\n\n\n<p>There is no regulatory exemption for the importation\nof ventilators and IVD swabs: the CE marking must be affixed on the products,\nas usual, in compliance with the current directives.<\/p>\n\n\n\n<p><em>Sources:  <\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/www.iss.it\/procedure-per-richiesta-produzione-mascherine\">https:\/\/www.iss.it\/procedure-per-richiesta-produzione-mascherine<\/a>   <\/p>\n\n\n\n<p><a href=\"https:\/\/www.iss.it\/documents\/20126\/0\/Circolare+MS+18.03.2020.pdf\/377a2035-5782-f8f3-62b7-20abb69b8e20?t=1584716189847\">https:\/\/www.iss.it\/documents\/20126\/0\/Circolare+MS+18.03.2020.pdf\/377a2035-5782-f8f3-62b7-20abb69b8e20?t=1584716189847<\/a> <\/p>\n\n\n\n<p><a href=\"https:\/\/www.iss.it\/documents\/20126\/0\/DECRETO-LEGGE+17+marzo+2020%2C+n.+18.pdf\/d1408caf-b6cd-55d9-292d-391527e8cae7?t=1584545717664\">https:\/\/www.iss.it\/documents\/20126\/0\/DECRETO-LEGGE+17+marzo+2020%2C+n.+18.pdf\/d1408caf-b6cd-55d9-292d-391527e8cae7?t=1584545717664<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.iss.it\/documents\/20126\/0\/Rapporto+ISS+COVID+2_+Protezioni_REV.V6.pdf\/740f7d89-6a28-0ca1-8f76-368ade332dae?t=1585569978473\">https:\/\/www.iss.it\/documents\/20126\/0\/Rapporto+ISS+COVID+2_+Protezioni_REV.V6.pdf\/740f7d89-6a28-0ca1-8f76-368ade332dae?t=1585569978473<\/a>  <\/p>\n\n\n\n<p><a href=\"http:\/\/www.salute.gov.it\/nuovocoronavirus\">http:\/\/www.salute.gov.it\/nuovocoronavirus <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Covid-19 medical emergency has led to the necessity to find medical devices and personal protective equipment (PPE). In response to  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[679],"tags":[],"class_list":["post-14197","post","type-post","status-publish","format-standard","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>COVID-19: in Italy emergency supply of medical devices and personal protective equipment<\/title>\n<meta name=\"description\" content=\"The Covid-19 medical emergency has led to the necessity to find medical devices and personal protective equipment (PPE). 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