{"id":4124,"date":"2022-01-28T10:54:00","date_gmt":"2022-01-28T09:54:00","guid":{"rendered":"https:\/\/sefiro.de\/?p=4124"},"modified":"2022-03-08T11:10:55","modified_gmt":"2022-03-08T10:10:55","slug":"aenderung-der-vo-eu-2017-746-ueber-in-vitro-diagnostika-ivdr-verlaengerte-uebergangsfristen-fuer-ivds","status":"publish","type":"post","link":"https:\/\/sefiro.de\/en\/2022\/01\/28\/aenderung-der-vo-eu-2017-746-ueber-in-vitro-diagnostika-ivdr-verlaengerte-uebergangsfristen-fuer-ivds\/","title":{"rendered":"\u00c4nderung der VO (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) &#8211; verl\u00e4ngerte \u00dcbergangsfristen f\u00fcr IVDs."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"4124\" class=\"elementor elementor-4124\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7fa1bc2d elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7fa1bc2d\" data-element_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-540d3156\" data-id=\"540d3156\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-98d4332 elementor-widget elementor-widget-text-editor\" data-id=\"98d4332\" data-element_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<p><!-- wp:paragraph --><\/p><p><em>Auf Grundlage der IVDR wird sch\u00e4tzungsweise f\u00fcr 80 % der In-vitro-Diagnostika (IVDs) eine benannte Stelle f\u00fcr deren Zulassung erforderlich sein. Aufgrund eines erheblichen Mangels an benannten Stellen und aufgrund der au\u00dfergew\u00f6hnlichen Umst\u00e4nde in Verbindung mit COVID 19 wird es gem\u00e4\u00df VO (EU) 2022\/112 vom 25.01.2022 auch f\u00fcr In-vitro-Diagnostika (IVDs) eine deutlich verl\u00e4ngerte \u00dcbergangsfrist f\u00fcr die Inverkehrbringung \/ Bereitstellung auf dem Markt geben. Zur Vermeidung von Versorgungsengp\u00e4ssen erfolgt eine schrittweise Einf\u00fchrung, abh\u00e4ngig von der Risikoklasse mit folgenden Fristen: <\/em><\/p><p><em><strong>Klasse D<\/strong> (h\u00f6chster Risikograd): 26.05.2025, Abverkauf bis 26 05.2026 <\/em><\/p><p><em><strong>Klasse C<\/strong> (hoher und mittlerer Risikograd): 26.05.2026, Abverkauf bis 26.05.2027<\/em><\/p><p><em><strong>Klasse B und Klasse A<\/strong> &#8211; steril (mittlerer oder geringer Risikograd): 26.05.2027, Abverkauf bis 26.05.28<\/em><\/p><p><em>F\u00fcr nicht-sterile Klasse-A-Produkte (geringster Risikograd), f\u00fcr neue Produkte (die unter der IVDD, also vor dem 26.05.2022, noch nicht zugelassen sind) und solche, f\u00fcr die keine benannte Stelle ben\u00f6tigt wird, gelten keine verl\u00e4ngerten \u00dcbergangsfristen. Auch f\u00fcr die Post Market-Surveillance, Vigilanz und Registrierung bleibt der urspr\u00fcngliche Zeitpunkt des Inkrafttretens der IVDR am 26.05.2022 bestehen.<\/em><\/p><p>\u00a0<\/p><p><strong>ERG\u00c4NZUNGEN, HINWEISE &amp; ANH\u00c4NGE<\/strong><br \/><br \/><em>Amtsblatt der Europ\u00e4ischen Union L19 vom 28.01.2022<\/em><\/p><p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/HTML\/?uri=CELEX:32022R0112R(01)\" target=\"_blank\" rel=\"noopener\"><em>https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/HTML\/?uri=CELEX:32022R0112R(01)<\/em><\/a><\/p><p><em>\u00a0<\/em><\/p><p><!-- \/wp:paragraph --><!-- wp:paragraph --><!-- \/wp:paragraph --><\/p>\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\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Auf Grundlage der IVDR wird sch\u00e4tzungsweise f\u00fcr 80 % der In-vitro-Diagnostika (IVDs) eine benannte Stelle f\u00fcr deren Zulassung erforderlich sein. Aufgrund eines erheblichen Mangels an benannten Stellen und aufgrund der au\u00dfergew\u00f6hnlichen Umst\u00e4nde in Verbindung mit COVID 19 wird es gem\u00e4\u00df VO (EU) 2022\/112 vom 25.01.2022 auch f\u00fcr In-vitro-Diagnostika (IVDs) eine deutlich verl\u00e4ngerte \u00dcbergangsfrist f\u00fcr die &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/sefiro.de\/en\/2022\/01\/28\/aenderung-der-vo-eu-2017-746-ueber-in-vitro-diagnostika-ivdr-verlaengerte-uebergangsfristen-fuer-ivds\/\"> <span class=\"screen-reader-text\">\u00c4nderung der VO (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) &#8211; verl\u00e4ngerte \u00dcbergangsfristen f\u00fcr IVDs.<\/span> Read More &raquo;<\/a><\/p>","protected":false},"author":3,"featured_media":2532,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[107,92],"tags":[],"class_list":["post-4124","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-gesetze-richtlinien-non-food","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00c4nderung der VO (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) - verl\u00e4ngerte \u00dcbergangsfristen f\u00fcr IVDs. &ndash; SEFIRO GROUP<\/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:\/\/sefiro.de\/en\/2022\/01\/28\/aenderung-der-vo-eu-2017-746-ueber-in-vitro-diagnostika-ivdr-verlaengerte-uebergangsfristen-fuer-ivds\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"\u00c4nderung der VO (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) - verl\u00e4ngerte \u00dcbergangsfristen f\u00fcr IVDs. &ndash; SEFIRO GROUP\" \/>\n<meta property=\"og:description\" content=\"Auf Grundlage der IVDR wird sch\u00e4tzungsweise f\u00fcr 80 % der In-vitro-Diagnostika (IVDs) eine benannte Stelle f\u00fcr deren Zulassung erforderlich sein. Aufgrund eines erheblichen Mangels an benannten Stellen und aufgrund der au\u00dfergew\u00f6hnlichen Umst\u00e4nde in Verbindung mit COVID 19 wird es gem\u00e4\u00df VO (EU) 2022\/112 vom 25.01.2022 auch f\u00fcr In-vitro-Diagnostika (IVDs) eine deutlich verl\u00e4ngerte \u00dcbergangsfrist f\u00fcr die &hellip; \u00c4nderung der VO (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) &#8211; verl\u00e4ngerte \u00dcbergangsfristen f\u00fcr IVDs. 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Aufgrund eines erheblichen Mangels an benannten Stellen und aufgrund der au\u00dfergew\u00f6hnlichen Umst\u00e4nde in Verbindung mit COVID 19 wird es gem\u00e4\u00df VO (EU) 2022\/112 vom 25.01.2022 auch f\u00fcr In-vitro-Diagnostika (IVDs) eine deutlich verl\u00e4ngerte \u00dcbergangsfrist f\u00fcr die &hellip; \u00c4nderung der VO (EU) 2017\/746 \u00fcber In-vitro-Diagnostika (IVDR) &#8211; verl\u00e4ngerte \u00dcbergangsfristen f\u00fcr IVDs. 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