{"id":10404,"date":"2024-12-09T15:00:56","date_gmt":"2024-12-09T14:00:56","guid":{"rendered":"https:\/\/scc-medical-devices.com\/?p=10404"},"modified":"2024-12-09T15:13:13","modified_gmt":"2024-12-09T14:13:13","slug":"mdcg-guidance-alert-neuer-leitfaden-mdcg-2024-16-zum-umgang-mit-unterbrechung-oder-einstellung","status":"publish","type":"post","link":"https:\/\/scc-medical-devices.com\/de\/mdcg-guidance-alert-neuer-leitfaden-mdcg-2024-16-zum-umgang-mit-unterbrechung-oder-einstellung\/","title":{"rendered":"MDCG Guidance Alert: Neuer Leitfaden MDCG 2024-16 zum Umgang mit Unterbrechung oder Einstellung"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"10404\" class=\"elementor elementor-10404 elementor-10394\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-52485b4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"52485b4\" data-element_type=\"section\" data-e-type=\"section\">\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-d37977e\" data-id=\"d37977e\" 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-2146dad elementor-widget elementor-widget-heading\" data-id=\"2146dad\" 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<h2 class=\"elementor-heading-title elementor-size-default\">Neuer Leitfaden MDCG 2024-16 zum Umgang mit Unterbrechung oder Einstellung <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a24eb13 elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"a24eb13\" 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<h6>9. Dezember 2024<\/h6>\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<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-top-section elementor-element elementor-element-c7167f3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c7167f3\" data-element_type=\"section\" data-e-type=\"section\">\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-1760445\" data-id=\"1760445\" 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<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-1b3d3a7 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b3d3a7\" data-element_type=\"section\" data-e-type=\"section\">\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-inner-column elementor-element elementor-element-c441eaf\" data-id=\"c441eaf\" 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-43dd55e elementor-widget elementor-widget-text-editor\" data-id=\"43dd55e\" 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>Die Medical Device Coordination Group (MDCG) hat k\u00fcrzlich ein neues Leitliniendokument, <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2024-16-manufacturer-information-form-interruption-or-discontinuation-supply-certain-medical-2024-12-06_en\" target=\"_blank\" rel=\"noopener\">MDCG 2024-16<\/a>, ver\u00f6ffentlicht. Dieses Dokument ist ein Informationsformular in Form einer Vorlage f\u00fcr Hersteller zum Ausf\u00fcllen im Falle einer Unterbrechung der Lieferkette oder der Einstellung der Produktion von Medizinprodukten oder IVDs.<\/p><p>Das MDCG-Dokument ist eine wichtige Erg\u00e4nzung zum <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/b431b10f-8512-4f47-9191-e1b84b2f9a27_en?filename=mdr_qna-article10a_mdr-ivdr_en.pdf\" target=\"_blank\" rel=\"noopener\">Q&amp;A-Dokument f\u00fcr Artikel 10a<\/a> der Verordnung (EU) 2024\/1860 zur \u00c4nderung der Verordnung (EU) 2017\/745 und der Verordnung (EU) 2017\/746.<\/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-9381e25 elementor-widget elementor-widget-text-editor\" data-id=\"9381e25\" 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>Bei Fragen zur Klassifizierung Ihres Produktes stehen Ihnen die <a href=\"https:\/\/scc-medical-devices.com\/de\/contact\/\" target=\"_blank\" rel=\"noopener\">SCC Experten<\/a> jederzeit zur Verf\u00fcgung.<\/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\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>Das neu ver\u00f6ffentliche MDCG-Dokument enth\u00e4lt ein Informationsformular f\u00fcr Hersteller zum Ausf\u00fcllen im Falle einer Unterbrechung der Lieferkette oder der Einstellung der Produktion von Medizinprodukten oder IVDs.<\/p>\n","protected":false},"author":3,"featured_media":10397,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33,11],"tags":[],"class_list":["post-10404","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-md-news-startseite","category-unkategorisiert"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/10404","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/comments?post=10404"}],"version-history":[{"count":10,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/10404\/revisions"}],"predecessor-version":[{"id":10414,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/10404\/revisions\/10414"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media\/10397"}],"wp:attachment":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media?parent=10404"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/categories?post=10404"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/tags?post=10404"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}