{"id":56704,"date":"2026-01-09T16:27:35","date_gmt":"2026-01-09T15:27:35","guid":{"rendered":"https:\/\/clariscience.com\/?post_type=corsi&#038;p=56704"},"modified":"2026-01-09T16:47:41","modified_gmt":"2026-01-09T15:47:41","slug":"come-compilare-il-manufacturer-incident-report-mir-di-un-dmivd","status":"publish","type":"corsi","link":"https:\/\/clariscience.com\/en\/corsi\/come-compilare-il-manufacturer-incident-report-mir-di-un-dmivd","title":{"rendered":"Come compilare il Manufacturer Incident Report (MIR) di un DM\/IVD"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"56704\" class=\"elementor elementor-56704\" data-elementor-post-type=\"corsi\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0661f3f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0661f3f\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;jet_parallax_layout_list&quot;:[]}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4076519\" data-id=\"4076519\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4d90bc1 elementor-widget elementor-widget-heading\" data-id=\"4d90bc1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">DI COSA PARLEREMO<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3259c67 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"3259c67\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Il quadro normativo europeo sui dispositivi medici e diagnostici in vitro (MDR e IVDR) impone <strong>requisiti rigorosi in materia di vigilanza<\/strong>, elemento centrale per tutelare la sicurezza di pazienti e utilizzatori. L\u2019edizione corrente della linea guida <strong>MDCG 2023-3 (rev. 2)<\/strong> fornisce <strong>chiarimenti preziosi su termini e concetti chiave<\/strong>, contribuendo a rendere pi\u00f9 chiaro il contesto regolatorio in cui ci muoviamo.<\/p><p>Questa Power Class rappresenta un\u2019occasione concreta per <strong>approfondire i requisiti di vigilanza previsti da MDR e IVDR<\/strong>, alla luce delle indicazioni contenute nella guida MDCG 2023-3 rev. 2, con l\u2019obiettivo di comprendere in modo completo gli <strong>adempimenti essenziali della dispositivo-vigilanza<\/strong>.<\/p><p>Un\u2019attenzione particolare sar\u00e0 rivolta alla <strong>redazione accurata e completa della nuova versione del Manufacturer Incident Report (MIR) 7.3.1<\/strong>. Questo strumento costituisce il <strong>fulcro della segnalazione alle Autorit\u00e0 Competenti<\/strong>: la sua corretta gestione non \u00e8 soltanto un obbligo normativo, ma la <strong>base per un sistema di vigilanza realmente efficace ed efficiente<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-eecb0d2 elementor-widget elementor-widget-heading\" data-id=\"eecb0d2\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">IN SINTESI<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b2a96ad elementor-list-item-link-full_width elementor-widget elementor-widget-icon-list\" data-id=\"b2a96ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-list.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-icon-list-items\">\n\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" class=\"feather feather-check\"><polyline points=\"20 6 9 17 4 12\"><\/polyline><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Requisiti di vigilanza MDR e IVDR: obblighi e responsabilit\u00e0 dei fabbricanti<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" class=\"feather feather-check\"><polyline points=\"20 6 9 17 4 12\"><\/polyline><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Chiarimenti e interpretazioni fornite dalla linea guida MDCG 2023-3 rev.2<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t<svg xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"24\" height=\"24\" viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"2\" stroke-linecap=\"round\" stroke-linejoin=\"round\" class=\"feather feather-check\"><polyline points=\"20 6 9 17 4 12\"><\/polyline><\/svg>\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text\">Manufacturer Incident Report (MIR) 7.3.1: redazione funzionale e completa del nuovo modello<\/span>\n\t\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d739db1 elementor-widget elementor-widget-heading\" data-id=\"d739db1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">A CHI \u00c8 DESTINATO<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25e5688 elementor-widget elementor-widget-text-editor\" data-id=\"25e5688\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Questa Power Class \u00e8 indirizzata a tutte le funzioni aziendali che si occupano di <strong>pianificare, eseguire ed implementare le attivit\u00e0 di sorveglianza per i propri dispositivi medici o diagnostici in vitro<\/strong>\u00a0(Regulatory Affairs, Clinical Affairs, Quality Management) e ai professionisti coinvolti nella loro <strong>realizzazione operativa<\/strong>, afferenti, per esempio, ai dipartimenti di Medical Affairs e Clinical Operations.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8b1f22f elementor-widget elementor-widget-text-editor\" data-id=\"8b1f22f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><em>Non perdere l\u2019occasione di partecipare alla PowerClass di Clariscience: un workshop breve ed efficace che far\u00e0 la differenza nella tua quotidianit\u00e0 lavorativa.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Quali sono i requisiti imposti da MDR&#038;IVDR in materia di vigilanza? Partecipa per imparare a compilare il Manufacturer Incident Report (MIR), strumento chiave per la segnalazione degli incidenti alle Autorit\u00e0 Competenti<\/p>\n","protected":false},"author":95,"featured_media":0,"template":"","meta":{"_acf_changed":false,"episode_type":"","audio_file":"","podmotor_file_id":"","podmotor_episode_id":"","cover_image":"","cover_image_id":"","duration":"","filesize":"","filesize_raw":"","date_recorded":"","explicit":"","block":"","footnotes":""},"argomento-corsi":[],"categorie-corsi":[387],"class_list":["post-56704","corsi","type-corsi","status-publish","hentry","categorie-corsi-affari-regolatori"],"acf":[],"yoast_head":"<title>Come compilare il Manufacturer Incident Report (MIR) di un DM\/IVD - Clariscience<\/title>\n<meta name=\"description\" content=\"Partecipa alla Power Class per imparare a compilare il MIR, strumento essenziale per la segnalazioni di incidenti di DM\/IVD alle AC\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/clariscience.com\/en\/corsi\/come-compilare-il-manufacturer-incident-report-mir-di-un-dmivd\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Come compilare il Manufacturer Incident Report (MIR) di un DM\/IVD - 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