{"id":58584,"date":"2021-05-26T12:47:14","date_gmt":"2021-05-26T10:47:14","guid":{"rendered":"https:\/\/www.fedaiisf.it\/?p=58584"},"modified":"2021-05-26T12:47:14","modified_gmt":"2021-05-26T10:47:14","slug":"dispositivi-medici-al-via-lapplicazione-del-regolamento-ue-2017-745","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/dispositivi-medici-al-via-lapplicazione-del-regolamento-ue-2017-745\/","title":{"rendered":"Medical devices, the application of Regulation (EU) 2017\/745 is underway"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-58586 alignleft\" src=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/05\/Dispositivi-data-regolamento.jpg\" alt=\"\" width=\"406\" height=\"226\" srcset=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/05\/Dispositivi-data-regolamento.jpg 700w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/05\/Dispositivi-data-regolamento-300x167.jpg 300w\" sizes=\"auto, (max-width: 406px) 100vw, 406px\" \/>From 26 May 2021 the <a title=\"opens pdf files on external site\" href=\"https:\/\/www.trovanorme.salute.gov.it\/norme\/renderNormsanPdf?anno=2017&amp;codLeg=59843&amp;parte=1%20&amp;serie=null\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2017\/745<\/a>. The regulation amends the rules governing the medical device system, taking into account the developments of the last twenty years, with the aim of guaranteeing a solid regulatory framework, suitable for maintaining a high level of\u00a0<strong>safety<\/strong>.<\/p>\n<p>National authorities, notified bodies, manufacturers, economic operators, health institutions and the other subjects involved will have to collaborate to improve the medical device system in the renewed regulatory framework provided for by the regulation.<\/p>\n<h4>The new regulatory context<\/h4>\n<p>Regulation (EU) 2017\/745, based on the principles of <a title=\"open external site\" href=\"https:\/\/ec.europa.eu\/growth\/single-market\/goods\/new-legislative-framework_en\" target=\"_blank\" rel=\"noopener\">New Legislative Framework<\/a>, in continuity with the principles of the New Approach, sets itself the goal of raising the quality and safety standards of the products and at the same time creating a sustainable legislative framework, conducive to<strong>innovation<\/strong> which places the EU as guarantor of global health and the proper functioning of the internal market in the medical devices sector.<\/p>\n<p>The <strong>May 26, 2021<\/strong> is, formally, the date from which the full applicability of Regulation 2017\/745 takes effect, however, as envisaged by the same, the non-operation of Eudamed allows the use of transitional solutions by the Member States as regards the registration of devices and operators economic, certification notifications, surveillance and clinical investigations.<\/p>\n<p>Furthermore, a derogation period begins in which some of the devices compliant with the directives will be able to continue to be legitimately placed on the market (legacy devices), at the latest until 26 May 2024.<\/p>\n<h4><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-58589 alignright\" src=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/05\/ICSMS.jpg\" alt=\"\" width=\"349\" height=\"209\" srcset=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/05\/ICSMS.jpg 512w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2021\/05\/ICSMS-300x180.jpg 300w\" sizes=\"auto, (max-width: 349px) 100vw, 349px\" \/>The Ministry of Health engaged on several fronts<\/h4>\n<p>The Ministry of Health, Competent Authority and Responsible Authority for Notified Bodies, is working on several fronts, including:<\/p>\n<ul>\n<li>Notified Bodies: a significant effort is currently underway to ensure an adequate presence of Italian notified bodies aimed at ensuring the conformity of devices on the market<\/li>\n<li>Participation in the MDCG working groups and in the task forces dedicated to the drafting of the MDCG guidance<\/li>\n<li>In the European database of medical devices - Eudamed, developed by the European Commission to implement Regulations (EU) 2017\/745 and 2017\/746, the &quot;player registration&quot; form is accessible; economic operators can register on a voluntary basis in order to obtain the SRN while having to comply with the obligation to register in the national database of medical devices. The integration of the national and European level registration systems is underway<\/li>\n<li>Adaptation of the national standard: according to the<a title=\"open external site\" href=\"https:\/\/www.trovanorme.salute.gov.it\/norme\/dettaglioAtto?id=80595&amp;articolo=15\" target=\"_blank\" rel=\"noopener\">art. 15 of Law 22 April 2021, n. 53<\/a>, the act of adaptation of the Italian legislation to the provisions of the regulation for the regulation of aspects of health interest, from clinical investigations to post-marketing surveillance, supervision and surveillance of the market is being prepared.<\/li>\n<\/ul>\n<p>For more information, consult the page:<\/p>\n<ul>\n<li><a href=\"https:\/\/www.salute.gov.it\/portale\/temi\/p2_6.jsp?lingua=italiano&amp;id=4971&amp;area=dispositivi-medici&amp;menu=caratteristichegenerali\" target=\"_blank\" rel=\"noopener\">The European regulations of medical devices<\/a><\/li>\n<\/ul>\n<p><a href=\"https:\/\/www.salute.gov.it\/portale\/news\/p3_2_1_1_1.jsp?lingua=italiano&amp;menu=notizie&amp;p=dalministero&amp;id=5499\" target=\"_blank\" rel=\"noopener\">Ministry of Health \u2013 25 May 2021<\/a><\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-41732 aligncenter\" src=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2019\/03\/Dispositivi-classificazione.jpg\" alt=\"\" width=\"960\" height=\"720\" srcset=\"https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2019\/03\/Dispositivi-classificazione.jpg 960w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2019\/03\/Dispositivi-classificazione-300x225.jpg 300w, https:\/\/www.fedaiisf.it\/wp-content\/uploads\/2019\/03\/Dispositivi-classificazione-768x576.jpg 768w\" sizes=\"auto, (max-width: 960px) 100vw, 960px\" \/><\/p>","protected":false},"excerpt":{"rendered":"<p>Dal 26 maggio 2021 \u00e8 pienamente applicabile il Regolamento (UE) 2017\/745. Il regolamento\u00a0modifica le norme che disciplinano il sistema dei dispositivi medici, tenendo conto degli sviluppi degli ultimi vent&#8217;anni, con l\u2019obiettivo di garantire un quadro normativo solido, idoneo a mantenere un elevato livello di\u00a0sicurezza. Autorit\u00e0 nazionali, organismi notificati, fabbricanti, operatori economici, istituzioni sanitarie e gli &hellip;<\/p>","protected":false},"author":4,"featured_media":29256,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[41],"class_list":["post-58584","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizie","tag-leggisentenze"],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/58584","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/comments?post=58584"}],"version-history":[{"count":0,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/posts\/58584\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media\/29256"}],"wp:attachment":[{"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/media?parent=58584"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/categories?post=58584"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.fedaiisf.it\/en\/wp-json\/wp\/v2\/tags?post=58584"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}