{"id":9722,"date":"2019-06-12T09:32:06","date_gmt":"2019-06-12T07:32:06","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=9722"},"modified":"2019-06-12T09:32:06","modified_gmt":"2019-06-12T07:32:06","slug":"quali-sono-i-requisiti-dellmdr-in-materia-di-sorveglianza-post-market-sorveglianza-del-mercato-e-vigilanza","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/quali-sono-i-requisiti-dellmdr-in-materia-di-sorveglianza-post-market-sorveglianza-del-mercato-e-vigilanza\/","title":{"rendered":"Quali sono i requisiti dell\u2019MDR in materia di sorveglianza post-market, sorveglianza del mercato e vigilanza?"},"content":{"rendered":"\n<p>Per tenere sotto controllo la\ntracciabilit\u00e0 dei dispositivi medici su tutta la filiera, i Regolamenti europei\nprevedono non solo dei requisiti pi\u00f9 stringenti per i Fabbricanti, ma anche un\nmaggiore coinvolgimento da parte degli altri operatori economici e degli Organismi\nNotificati. <\/p>\n\n\n\n<p>In conformit\u00e0 con l\u2019MDR, il fabbricante deve disporre di:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>un sistema di gestione della qualit\u00e0 (SGQ);<\/li><li>un sistema di sorveglianza <em>post-market<\/em> (PMS); <\/li><li>un sistema di gestione del rischio; <\/li><li>un sistema per la segnalazione di incidenti e di\nazioni correttive di sicurezza (vigilanza) alle Autorit\u00e0 competenti.<\/li><\/ul>\n\n\n\n<p>Il Fabbricante deve \u201c<em>pianificare, istituire, documentare, applicare, mantenere e aggiornare un sistema di sorveglianza post-commercializzazione, parte integrante del sistema di gestione della qualit\u00e0 dell\u2019organizzazione<\/em>\u201d (Rif. Art. 83 dell\u2019MDR e Art.78 dell\u2019IVDR)<\/p>\n\n\n\n<p>Le attivit\u00e0 inerenti alla PMS devono essere garantite all\u2019interno dell\u2019organizzazione del fabbricante da una <strong><a href=\"http:\/\/www.thema-med.com\/persona-responsabile-la-formazione-dellesperto-in-affari-regolatori\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Persona Responsabile<\/a><\/strong> del rispetto della normativa, in possesso di requisiti minimi di qualifica (Rif. Art. 15 dell\u2019MDR).<\/p>\n\n\n\n<p style=\"background-color:#0099a8;text-align:center\" class=\"has-text-color has-background has-very-light-gray-color\">Domande? Chiedi maggiori informazioni ai nostri specialisti<br><a rel=\"noreferrer noopener\" href=\"http:\/\/www.thema-med.com\/contatti\/\" target=\"_blank\">CONTATTACI<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Per tenere sotto controllo la tracciabilit\u00e0 dei dispositivi medici su tutta la filiera, i Regolamenti europei prevedono non solo dei requisiti  [&#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":[14,21],"tags":[],"class_list":["post-9722","post","type-post","status-publish","format-standard","hentry","category-faq","category-impatto-mdr-certificati-ce-mdd-period-of-grace"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO 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