{"id":1249,"date":"2025-02-12T10:35:57","date_gmt":"2025-02-12T09:35:57","guid":{"rendered":"https:\/\/eumedmedical.it\/affari-regolatori-dispositivi-medici\/"},"modified":"2025-02-19T13:18:34","modified_gmt":"2025-02-19T12:18:34","slug":"medical-device-regulatory-affairs","status":"publish","type":"page","link":"https:\/\/eumedmedical.it\/en\/medical-device-regulatory-affairs\/","title":{"rendered":"Medical device regulatory affairs"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1249\" class=\"elementor elementor-1249 elementor-639\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7256960 e-con-full e-flex e-con e-parent\" data-id=\"7256960\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_gallery&quot;:[{&quot;id&quot;:641,&quot;url&quot;:&quot;https:\\\/\\\/eumedmedical.it\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/classificazione-dispositivi-medici-eumed-orizz.jpg&quot;},{&quot;id&quot;:642,&quot;url&quot;:&quot;https:\\\/\\\/eumedmedical.it\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/fornitori-pubblica-amministrazione-eumed-orizz.jpg&quot;},{&quot;id&quot;:643,&quot;url&quot;:&quot;https:\\\/\\\/eumedmedical.it\\\/wp-content\\\/uploads\\\/2025\\\/02\\\/marcatura-ce-eumed-orizz.jpg&quot;}],&quot;background_slideshow_ken_burns&quot;:&quot;yes&quot;,&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500,&quot;background_slideshow_ken_burns_zoom_direction&quot;:&quot;in&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-85951fc e-flex e-con-boxed e-con e-child\" data-id=\"85951fc\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;slideshow&quot;,&quot;background_slideshow_ken_burns&quot;:&quot;yes&quot;,&quot;background_slideshow_gallery&quot;:[],&quot;background_slideshow_loop&quot;:&quot;yes&quot;,&quot;background_slideshow_slide_duration&quot;:5000,&quot;background_slideshow_slide_transition&quot;:&quot;fade&quot;,&quot;background_slideshow_transition_duration&quot;:500,&quot;background_slideshow_ken_burns_zoom_direction&quot;:&quot;in&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-c5c736e e-con-full e-flex e-con e-child\" data-id=\"c5c736e\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e23848f elementor-widget elementor-widget-heading\" data-id=\"e23848f\" 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<h1 class=\"elementor-heading-title elementor-size-default\">Medical device regulatory affairs<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-641c272 e-flex e-con-boxed e-con e-parent\" data-id=\"641c272\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-657eaa5 elementor-widget elementor-widget-text-editor\" data-id=\"657eaa5\" 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>The field of <strong>medical devices<\/strong> is regulated by complex and constantly evolving regulations. With the entry into force of the European Regulation 2017\/745 (MDR medical devices) and the European Regulation 2017\/746 (IVDR), it is essential to guarantee full compliance of the products with the requirements required for placing them on the market.<br \/>Eumed\u00ae offers expert and specialized support for regulatory affairs, providing assistance and support at all stages.<\/p><p>We have recorded more than 50 thousand articles of every kind and class in the <strong>Medical Devices Directory<\/strong> of the Ministry of Health. We can offer immediate support to manufacturers and distributors to help them obtain the stock number for their products within a few days.<\/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\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-9b85811 e-flex e-con-boxed e-con e-parent\" data-id=\"9b85811\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;,&quot;sticky&quot;:&quot;top&quot;,&quot;sticky_on&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;],&quot;sticky_offset&quot;:100,&quot;sticky_offset_tablet&quot;:95,&quot;sticky_offset_mobile&quot;:90,&quot;sticky_effects_offset&quot;:0,&quot;sticky_anchor_link_offset&quot;:0}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-43a8344 e-con-full e-flex e-con e-child\" data-id=\"43a8344\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2516a31 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"2516a31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#ce-marking\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"CE marking\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#ce-marking\" >\n\t\t\t\t\t\t\tCE marking\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c69b4cd e-con-full e-flex e-con e-child\" data-id=\"c69b4cd\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a4056cf elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"a4056cf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#device-classification\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Device classification\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#device-classification\" >\n\t\t\t\t\t\t\tDevice classification\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-a8d0c51 e-con-full e-flex e-con e-child\" data-id=\"a8d0c51\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-7516724 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"7516724\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#clinical-investigations\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Clinical investigations\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#clinical-investigations\" >\n\t\t\t\t\t\t\tClinical investigations\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-370e830 e-con-full e-flex e-con e-child\" data-id=\"370e830\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a041a91 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"a041a91\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#medical-device-registration\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Medical Device Registration\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#medical-device-registration\" >\n\t\t\t\t\t\t\tMedical Device Registration\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-de87c45 e-con-full e-flex e-con e-child\" data-id=\"de87c45\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ba6ff4b elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"ba6ff4b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#labeling\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Labeling\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#labeling\" >\n\t\t\t\t\t\t\tLabeling\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-78b3e8b e-con-full e-flex e-con e-child\" data-id=\"78b3e8b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8e8f6c8 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"8e8f6c8\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#prrc\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Person Responsible for compliance with the law\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#prrc\" >\n\t\t\t\t\t\t\tPerson Responsible for compliance with the law\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-156ae0c e-con-full e-flex e-con e-child\" data-id=\"156ae0c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-be3214f elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"be3214f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#relations-with-notified-bodies\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Relations with Notified Bodies\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#relations-with-notified-bodies\" >\n\t\t\t\t\t\t\tRelations with Notified Bodies\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-02d160c e-con-full e-flex e-con e-child\" data-id=\"02d160c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-f825b5f elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"f825b5f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#relations-with-public-administration\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Relations with Public Administration\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#relations-with-public-administration\" >\n\t\t\t\t\t\t\tRelations with Public Administration\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-dcaf84c e-con-full e-flex e-con e-child\" data-id=\"dcaf84c\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-009d8b1 elementor-position-inline-start elementor-view-default elementor-mobile-position-block-start elementor-widget elementor-widget-icon-box\" data-id=\"009d8b1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"icon-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-box-wrapper\">\n\n\t\t\t\t\t\t<div class=\"elementor-icon-box-icon\">\n\t\t\t\t<a href=\"#healthcare-advertising\" class=\"elementor-icon\" tabindex=\"-1\" aria-label=\"Healthcare Advertising\">\n\t\t\t\t<i aria-hidden=\"true\" class=\"huge huge-arrow-down-02-round\"><\/i>\t\t\t\t<\/a>\n\t\t\t<\/div>\n\t\t\t\n\t\t\t\t\t\t<div class=\"elementor-icon-box-content\">\n\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-icon-box-title\">\n\t\t\t\t\t\t<a href=\"#healthcare-advertising\" >\n\t\t\t\t\t\t\tHealthcare Advertising\t\t\t\t\t\t<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2bc5af1 e-flex e-con-boxed e-con e-parent\" data-id=\"2bc5af1\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-36f9e71 e-con-full e-flex e-con e-child\" data-id=\"36f9e71\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e5a0d3d elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"e5a0d3d\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"ce-marking\"><\/div>\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-c360baa elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"c360baa\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-379596a elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"379596a\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">CE marking<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a16645f elementor-widget elementor-widget-text-editor\" data-id=\"a16645f\" 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>The placing on the market of a medical device is subject to obtaining the <strong>CE marking<\/strong>, except for some specific exceptions provided for by law. This mark certifies the conformity of the device with the essential requirements established by Regulation (EU) 2017\/745 (MDR) for medical devices and by Regulation (EU) 2017\/746 (IVDR) for in vitro diagnostic devices.<\/p><p>The manufacturer is primarily responsible for the conformity of the medical device and must ensure that it meets all applicable requirements, in particular those listed in Annex I of the MDR and in the previous legislative decrees 46\/97 and 37\/2010 (which implement Directive 2007\/47\/EC). This process involves the preparation of a <strong><a href=\"https:\/\/eumedmedical.it\/en\/medical-devices-technical-file\/\">complete technical file<\/a><\/strong>, which includes data relating to the design, manufacturing, risk assessment and clinical evidence of the device.<\/p><p>Eumed\u00ae, thanks to twenty years of experience in the regulatory sector, supports manufacturers at every stage of the certification process, offering strategic and operational support for obtaining the CE marking. In addition to the initial certification, we guarantee continuous assistance for maintaining compliance over time, and for the management of regulatory obligations deriving from the evolution of the European legislative framework.<\/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-9e907b7 elementor-widget elementor-widget-button\" data-id=\"9e907b7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-cc4480d e-flex e-con-boxed e-con e-parent\" data-id=\"cc4480d\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-f1f0633 e-con-full e-flex e-con e-child\" data-id=\"f1f0633\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e97d27a elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"e97d27a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"device-classification\"><\/div>\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-e0453ff elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e0453ff\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-d33fa9b elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"d33fa9b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Medical device classification<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e7db4ba elementor-widget elementor-widget-text-editor\" data-id=\"e7db4ba\" 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>The correct <strong>classification of medical devices<\/strong> allows you to determine the applicable regulatory requirements and the most appropriate certification path. The <strong>European Regulation 2017\/745 (MDR)<\/strong> and the <strong>European Regulation 2017\/746 (IVDR)<\/strong> establish rigorous criteria to assign the risk class of a device based on its intended use, duration of application and level of invasiveness.<\/p><p><strong>Eumed\u00ae<\/strong> supports customers in accurately identifying the risk class of their devices, ensuring an assessment compliant with current regulations. Furthermore, we take care of the attribution of the <strong>CND code (National Classification of Devices)<\/strong>, mandatory for registration in national databases. It is important to note that CND was chosen as the basis for the <strong>European Medical Device Nomenclature (EMDN)<\/strong>, used within the MDR for the registration of medical devices.<\/p><p>Our team of experts can assist customers in obtaining EMDN, MDA, MDT and MDS classifications for the European Union, ensuring that the device is registered and cataloged in accordance with European regulations. This approach ensures efficient management of the classification process, facilitating access to the European medical device market.<\/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-eb7335b elementor-widget elementor-widget-button\" data-id=\"eb7335b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-776cb93 e-flex e-con-boxed e-con e-parent\" data-id=\"776cb93\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-b935161 e-con-full e-flex e-con e-child\" data-id=\"b935161\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-82c4ea9 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"82c4ea9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"clinical-investigations\"><\/div>\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-7169de9 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"7169de9\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-9b8d5ad elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"9b8d5ad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Clinical investigations<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9ab336e elementor-widget elementor-widget-text-editor\" data-id=\"9ab336e\" 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>The <strong>clinical investigations<\/strong> are essential for demonstrating the safety and performance of products before they are placed on the market or for new indications of use, and are now also regulated by Regulation (EU) 2017\/745 (MDR).<\/p><p>Per <strong>devices not bearing the CE marking<\/strong>, with <strong>CE marking for a use other than that under study<\/strong>, it is mandatory to submit an application to the Ministry of Health before starting the clinical investigation.<\/p><p>The application must be accompanied by a favorable opinion from a Territorial (CET) or National (CEN) Ethics Committee, valid throughout the national territory and binding for all centers involved in the study.<\/p><p><strong>For class III devices or implantable devices<\/strong>, a specific authorization from the Ministry of Health is required, issued after an in-depth technical-scientific evaluation. The standard timeframe for this assessment is 45 days from validation of the application, extendable by a further 20 days if expert advice is required. During this period, the Ministry may request clarifications or additions to the sponsor, temporarily suspending the evaluation deadlines.<\/p><p>Eumed\u00ae offers complete support in managing <strong>clinical investigations on medical devices<\/strong>, assisting manufacturers in preparing the necessary documentation, interacting with the competent authorities and complying with current regulations, to ensure an efficient path towards the authorization and conduct of clinical trials.<\/p><p>Thanks to a strategic partnership (MED DEVICE LAB scarl \u2013 consortium company between La Sapienza University of Rome and Confindustra Dispositivi Medici) and to a<br \/>deep knowledge of European regulations, we offer complete assistance in the phases of:<\/p><ol><li><strong>Planning<\/strong>: preparation of the CIP and documentation (IB, CRF, plan<br \/>monitoring, agreements and labelling).<\/li><li><strong>Startup<\/strong>: recruitment of subjects and start of data collection according to the protocol<br \/>established.<\/li><li><strong>Monitoring and Compliance<\/strong>: continuous supervision, risk management and compliance<br \/>of privacy.<\/li><li><strong>Any Suspensions\/Interruptions<\/strong>: protocol for suspension or closure<br \/>of the investigation.<\/li><li><strong>Closing and Reporting<\/strong>: producing a final report and keeping it for a long time deadline of the documents for any checks<\/li><\/ol>\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-9d8ccea elementor-widget elementor-widget-button\" data-id=\"9d8ccea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-fbcad0b e-flex e-con-boxed e-con e-parent\" data-id=\"fbcad0b\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-0e09429 e-con-full e-flex e-con e-child\" data-id=\"0e09429\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-e761d82 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"e761d82\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"medical-device-registration\"><\/div>\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-f241f43 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"f241f43\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-89509d3 elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"89509d3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Registration of medical devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b053cf9 elementor-widget elementor-widget-text-editor\" data-id=\"b053cf9\" 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>The placing on the Italian market of medical devices and in vitro diagnostic medical devices requires registration in the <strong>Medical Device Database<\/strong> of the <strong>Ministry of Health<\/strong>. This obligation extends to manufacturers, assemblers, importers and other economic operators involved in the distribution of such devices.<\/p><p><strong>Eumed\u00ae<\/strong> offers complete support for the registration of medical devices in the Ministry of Health Repertoire, ensuring efficient and accurate management of the necessary documentation. Our team of experts assists clients in collecting and verifying the required information, ensuring that all data is complete, consistent and compliant with current regulations.<br \/>Furthermore, with the entry into force of Regulation (EU) 2017\/745 (MDR) and Regulation (EU) 2017\/746 (IVDR), the <strong>EUDAMED European database<\/strong>, designed to centralize information on medical devices and economic operators at the level of the European Union.<\/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-002f554 elementor-widget elementor-widget-n-accordion\" data-id=\"002f554\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1930\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1930\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is Eudamed? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"huge huge-minus-sign-circle\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"huge huge-plus-sign-circle\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1930\" class=\"elementor-element elementor-element-1ef87ac e-con-full e-flex e-con e-child\" data-id=\"1ef87ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-dac0998 elementor-widget elementor-widget-text-editor\" data-id=\"dac0998\" 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>The art. 33 of the MDR Regulation and art. 30 of the IVDR Regulation provides for the establishment of <strong>European Device Database<\/strong> per following purposes:<\/p><ul><li>allow the public to be adequately informed about the devices placed on the market, the related certificates issued by the notified bodies and the economic operators involved<\/li><li>enable the unique identification of devices in the internal market and facilitate their traceability;<\/li><li>enable the public to be adequately informed about clinical investigations and sponsors of clinical investigations to meet their obligations with respect to DMs and performance studies with respect to IVDs<\/li><li>enable manufacturers to comply with information obligations<\/li><li>enable the competent authorities of the Member States and the Commission to carry out their tasks in relation to this Regulation on an informed basis and to strengthen mutual cooperation.<\/li><\/ul><p>The following electronic systems are part of Eudamed:<\/p><ul><li>the electronic system relating to the registration of devices<\/li><li>at the UDI database<\/li><li>the electronic system relating to the registration of economic operators<\/li><li>the electronic system for notified bodies and certificates<\/li><li>the electronic system for clinical investigations for medical devices and for studies of the performance of in vitro diagnostic devices<\/li><li>the electronic system for vigilance and post-marketing surveillance<\/li><li>the electronic system for market surveillance.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\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-ca30348 elementor-widget elementor-widget-text-editor\" data-id=\"ca30348\" 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><strong>Eumed\u00ae<\/strong> supports manufacturers and other economic operators in the registration procedure in EUDAMED, assisting in the creation and management of the company profile, in the request for the Single Registration Number (SRN) and in the insertion of device data. Our aim is to ensure a smooth and compliant transition to the new European regulations, keeping clients updated on regulatory developments and ensuring that all registrations are carried out in a timely and efficient manner.<\/p><p><strong>Eumed\u00ae<\/strong> is able to provide the necessary assistance for the correct device registration procedure in EUDAMED with its own access credentials to the system, and as a subcontractor of the manufacturer. Following the most recent evolutions of Eudamed&#8217;s computerized systems, our company is already able to communicate with the System through the expected IT protocols, speeding up the communication and registration process.<\/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-932fb73 elementor-widget elementor-widget-button\" data-id=\"932fb73\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2b472df e-flex e-con-boxed e-con e-parent\" data-id=\"2b472df\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-6d6834d e-con-full e-flex e-con e-child\" data-id=\"6d6834d\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-0eb6d09 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"0eb6d09\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"labeling\"><\/div>\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-820b61c elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"820b61c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-f67f8ef elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"f67f8ef\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Labeling of medical devices<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e1ed252 elementor-widget elementor-widget-text-editor\" data-id=\"e1ed252\" 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>Labeling medical devices helps ensure the safe and effective use of products by end users. According to the <strong>Regulation (EU) 2017\/745 (MDR)<\/strong>, the information provided must be clear, legible and understandable for end users. This information must include details of the device identification, manufacturer, expected performance, conditions of use and any precautions or warnings.<\/p><p><strong>Eumed\u00ae<\/strong> supports manufacturers, distributors and importers of medical devices in correct drafting of labels, instructions for use and regulatory symbols, ensuring both linguistic and graphic compliance with current regulations. Our support extends to manufacturers, distributors and importers of medical devices and in vitro diagnostic devices, ensuring that labeling complies with MDR requirements.<\/p><p>Furthermore, we assist in the management of <strong>Unique Device Identification (UDI)<\/strong>, a system introduced by the MDR to improve the traceability of medical devices. The UDI must be applied both on the device and on all higher packaging levels, according to the specifications dictated by the regulation.<\/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-524f714 elementor-widget elementor-widget-button\" data-id=\"524f714\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-255ed93 e-flex e-con-boxed e-con e-parent\" data-id=\"255ed93\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-17b18cc e-con-full e-flex e-con e-child\" data-id=\"17b18cc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-3e260e1 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"3e260e1\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"prrc\"><\/div>\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-0093645 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"0093645\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-d232b5d elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"d232b5d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">PRRC: Person Responsible for Compliance with the Regulations<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5609670 elementor-widget elementor-widget-text-editor\" data-id=\"5609670\" 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>The art. 15 present in <strong>Regulations (EU) 2017\/745 and 2017\/746<\/strong> introduced the obligation for manufacturers and authorized representatives to equip themselves with one Person Responsible for Compliance with the Regulations (PRRC), establishing tasks and requirements. This figure is responsible for supervising the entire compliance process and ensuring that the organization complies with all the provisions of the European Regulations on medical devices and in vitro diagnostic devices.<\/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-0d17551 elementor-widget elementor-widget-n-accordion\" data-id=\"0d17551\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1370\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1370\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What does PRRC do? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><i aria-hidden=\"true\" class=\"huge huge-minus-sign-circle\"><\/i><\/span>\n\t\t\t<span class='e-closed'><i aria-hidden=\"true\" class=\"huge huge-plus-sign-circle\"><\/i><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1370\" class=\"elementor-element elementor-element-3ffa8ac e-con-full e-flex e-con e-child\" data-id=\"3ffa8ac\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-d4feefc elementor-widget elementor-widget-text-editor\" data-id=\"d4feefc\" 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>The PRRC must ensure that:<\/p><ul><li>the conformity of the devices is adequately controlled in accordance with the quality management system under which the devices are manufactured before the release of a device;<\/li><li>the technical documentation and the EU declaration of conformity are drawn up and updated;<\/li><li>the post-marketing surveillance obligations of the manufacturer are satisfied (art.10, paragraph 10);<\/li><li>the reporting obligations set out in Articles 87 to 91 are satisfied;<\/li><li>in the case of devices under investigation, the declaration referred to in Annex XV, chapter II, point 4.1 is issued<\/li><\/ul><p>It is also responsible for providing information and documentation requested to the competent authorities and actively collaborating with them during any inspections.<br \/>It is important that this figure has appropriate skills and knowledge to effectively carry out his responsibilities and has the support and resources necessary from the organization to ensure continuous compliance with the legislation.<\/p><p>Skills for the person responsible for the legislation<\/p><ul><li>a diploma, certificate or other qualification obtained by completing university studies, or a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in the field of regulation or quality management systems relating to medical devices;<\/li><\/ul><p>or<\/p><ul><li>four years of professional experience in the field of regulatory or quality management systems related to medical devices.<\/li><\/ul><p>Manufacturers of custom-made devices can demonstrate the necessary skills by having at least two years of professional experience in the relevant manufacturing field.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\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-0da95dc elementor-widget elementor-widget-text-editor\" data-id=\"0da95dc\" 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\tFor companies that do not have the possibility of appointing an internal Responsible Person, Eumed\u00ae, after careful and scrupulous company analysis, can make its knowledge and skills available for the PRRC service.\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-9de667f elementor-widget elementor-widget-button\" data-id=\"9de667f\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-3f26aec e-flex e-con-boxed e-con e-parent\" data-id=\"3f26aec\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-22375b2 e-con-full e-flex e-con e-child\" data-id=\"22375b2\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a78b9f7 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"a78b9f7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"relations-with-notified-bodies\"><\/div>\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-e58002c elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"e58002c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-2fce3ed elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"2fce3ed\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Relations with Notified Bodies (ON)<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-46b6951 elementor-widget elementor-widget-text-editor\" data-id=\"46b6951\" 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>The <strong>Notified Bodies<\/strong> are those bodies designated by a Member State of the European Union to carry out conformity assessment activities of in vitro medical and diagnostic devices pursuant to Regulation (EU) 2017\/745 and Regulation (EU) 2017\/746.<\/p><p>For classes higher than the first (Ir, Is, IIa, IIb, III) the Notified Body is required to verify the conformity of the medical devices by evaluating the technical documentation and the manufacturer&#8217;s quality system, in order to ensure the safety and performance of the product<\/p><p>Over the years we have found that the greatest difficulty highlighted by companies is not so much satisfying legal requirements, but rather establishing an effective dialogue with the body responsible for verifying compliance.<\/p><p>This is why Eumed\u00ae offers complete support to companies in the medical device certification process, from the choice of the most suitable body to the interactions during the preliminary and audit phases and also in the interactions following certification.<\/p><p>Our intervention, thanks to the experience gained over the years and the preparation of our team, also includes the analysis of the findings and the definition of document changes and process necessary to achieve compliance.<\/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-2c5eeaf elementor-widget elementor-widget-button\" data-id=\"2c5eeaf\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-8e09fa2 e-flex e-con-boxed e-con e-parent\" data-id=\"8e09fa2\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-33b4f55 e-con-full e-flex e-con e-child\" data-id=\"33b4f55\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-04edff7 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"04edff7\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"relations-with-public-administration\"><\/div>\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-5386e4c elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"5386e4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-9074f18 elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"9074f18\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Relations with the public administration<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a9b138d elementor-widget elementor-widget-text-editor\" data-id=\"a9b138d\" 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>Economic operators operating in the medical device sector often find themselves dealing with the Public Administration, for example in terms of healthcare advertising, healthcare clearance or free sales certificate.<br \/>The <strong>Health Clearance<\/strong> is the necessary document that the importer must obtain in order to place medical devices produced by non-EU countries on the Italian market. In fact, these devices are monitored by the <strong>Health offices maritime, air and border (USMAF)<\/strong>, as peripheral offices of the Ministry of Health, which carry out surveillance activities to protect public health.<\/p><p>The supervisory activity is carried out through three levels of verification (documentary, identity, material, including sampling for analysis purposes) to ascertain the compliance of the goods of health interest with the requirements and prescriptions established by national and European regulations. The supervisory activity ends with the final release of an import admission provision, the Health Authorization &#8211; NOS or with a non-import provision, in the event of failure to pass the checks.<\/p><p>Eumed\u00ae provides a specialized team that can assist you in the procedure for requesting this health authorization, thus speeding up the time it takes to import goods while awaiting checks. Furthermore, we also offer the registration service in the medical device database, necessary to be able to distribute the relevant devices once imported.<\/p><p>The <strong>Free Sale Certificate<\/strong> is required to be able to export medical devices outside the European Union. Italian manufacturers and agents can request this certificate from the Ministry, which issues it after verifying the documentation presented in support of the request.<\/p><p>Eumed\u00ae offers support in preparing the request and all the necessary documentation in order to obtain this certificate.<\/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-39cdd1c elementor-widget elementor-widget-button\" data-id=\"39cdd1c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2abc144 e-flex e-con-boxed e-con e-parent\" data-id=\"2abc144\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-bac9dee e-con-full e-flex e-con e-child\" data-id=\"bac9dee\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c90e99 elementor-absolute elementor-widget elementor-widget-menu-anchor\" data-id=\"5c90e99\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_position&quot;:&quot;absolute&quot;}\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-menu-anchor\" id=\"healthcare-advertising\"><\/div>\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-60c06d0 elementor-view-default elementor-widget elementor-widget-icon\" data-id=\"60c06d0\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;motion_fx_motion_fx_scrolling&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_effect&quot;:&quot;yes&quot;,&quot;motion_fx_opacity_range&quot;:{&quot;unit&quot;:&quot;%&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:{&quot;start&quot;:20,&quot;end&quot;:60}},&quot;motion_fx_opacity_direction&quot;:&quot;out-in&quot;,&quot;motion_fx_opacity_level&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:10,&quot;sizes&quot;:[]},&quot;motion_fx_devices&quot;:[&quot;widescreen&quot;,&quot;desktop&quot;,&quot;laptop&quot;,&quot;tablet_extra&quot;,&quot;tablet&quot;,&quot;mobile_extra&quot;,&quot;mobile&quot;]}\" data-widget_type=\"icon.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-icon-wrapper\">\n\t\t\t<div class=\"elementor-icon\">\n\t\t\t<i aria-hidden=\"true\" class=\"eumed eumed-servizi\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\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-1e2f7c4 elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"1e2f7c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"ha-gradient-heading\">Healthcare Advertising<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c23806 elementor-widget elementor-widget-text-editor\" data-id=\"4c23806\" 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>Health advertising, in Italy, is subject to obtaining authorization from the Ministry of Health and is regulated respectively by <strong>D.Lgs 137\/2022<\/strong>, for medical devices, and from <strong>D.Lgs 138\/2022<\/strong>, for in vitro medical devices. We at Eumed\u00ae we offer assistance in the procedure required to request this authorization.<\/p><p>The regulation concerns any type of means of dissemination and provides, in art. 7 of EU Regulation 2017\/745, that advertising cannot be carried out using texts, names, trademarks, images and figurative or other signs that could mislead the user or patient regarding the intended use, safety and performance of the device. This is achieved, explains the standard, when for example functions and properties of which it lacks are attributed to the device, or incorrect impressions are created regarding the treatment or diagnosis, functions or properties of which the device lacks, or the user or patient is omitted to be informed about a potential risk associated with the use of the device according to its intended use, or a use of the device different from that declared in the intended use for which the conformity assessment was carried out is proposed.<\/p><p>Furthermore, the Ministry of Health has also found that manufacturers often include claims, images, references to clinical studies and\/or statistical investigations and QR codes containing advertising messages in labels and instructions for use. This is an absolutely incorrect practice as Regulation 2017\/745 which precisely regulates the content of labels and instructions for use does not provide for the possibility of inserting promotional messages.<\/p><p><strong>Eumed\u00ae<\/strong> offers assistance in the correct drafting of documentation and promotional messages relating to the products to avoid incurring regulatory non-compliance and sanctions.<\/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-d09eb0c elementor-widget elementor-widget-button\" data-id=\"d09eb0c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Request information<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-400ff86 e-flex e-con-boxed e-con e-parent\" data-id=\"400ff86\" data-element_type=\"container\" data-e-type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a98ee15 elementor-widget__width-initial elementor-widget elementor-widget-ha-gradient-heading happy-addon ha-gradient-heading\" data-id=\"a98ee15\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"ha-gradient-heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"ha-gradient-heading\">Medical device regulatory affairs: request information about our services.<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-72b0375 elementor-widget elementor-widget-button\" data-id=\"72b0375\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/eumedmedical.it\/en\/contacts\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\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\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical device regulatory affairs The field of medical devices is regulated by complex and constantly evolving regulations. With the entry into force of the European Regulation 2017\/745 (MDR medical devices) and the European Regulation 2017\/746 (IVDR), it is essential to guarantee full compliance of the products with the requirements required for placing them on the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-1249","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Medical device regulatory affairs - Eumed Medical<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/eumedmedical.it\/en\/medical-device-regulatory-affairs\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Medical device regulatory affairs - Eumed Medical\" \/>\n<meta property=\"og:description\" content=\"Medical device regulatory affairs The field of medical devices is regulated by complex and constantly evolving regulations. 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