{"id":7795,"date":"2023-05-02T09:17:16","date_gmt":"2023-05-02T07:17:16","guid":{"rendered":"https:\/\/scc-medical-devices.com\/?p=7795"},"modified":"2023-05-03T16:34:38","modified_gmt":"2023-05-03T14:34:38","slug":"team-nb-aktualisiert-den-leitfaden-zur-einreichung-der-technischen-dokumentation-fuer-medizinprodukte","status":"publish","type":"post","link":"https:\/\/scc-medical-devices.com\/de\/team-nb-aktualisiert-den-leitfaden-zur-einreichung-der-technischen-dokumentation-fuer-medizinprodukte\/","title":{"rendered":"Team-NB aktualisiert den Leitfaden zur Einreichung der Technischen Dokumentation f\u00fcr Medizinprodukte"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7795\" class=\"elementor elementor-7795 elementor-7783\" 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\">Team-NB aktualisiert den Leitfaden zur Einreichung der Technischen Dokumentation f\u00fcr Medizinprodukte<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e06e54d elementor-widget elementor-widget-text-editor\" data-id=\"e06e54d\" 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>2. Mai 2023<\/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-123b3a3 elementor-widget elementor-widget-text-editor\" data-id=\"123b3a3\" 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>Am 19. April 2023 ver\u00f6ffentlichte <strong>t<\/strong>he <strong>E<\/strong>uropean <strong>A<\/strong>ssociation of <strong>M<\/strong>edical devices <strong>N<\/strong>otified <strong>B<\/strong>odies, kurz Team-NB, Version 2 der Stellungnahme \u201c<a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/members\/M2023\/Team-NB-List-PositionPapers-20230424.pdf\" target=\"_blank\" rel=\"noopener\"><em>Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017\/745<\/em><\/a>\u201d.<\/p><p>Der Leitfaden f\u00fcr die Einreichung der technischen Dokumentation orientiert sich an den Anforderungen der <a href=\"https:\/\/www.team-nb.org\/wp-content\/uploads\/members\/M2023\/Team-NB-List-PositionPapers-20230424.pdf\" target=\"_blank\" rel=\"noopener\">Medizinprodukteverordnung [MDR] (EU) 2017\/745<\/a> und soll den Zweck erf\u00fcllen, einen einheitlichen Ansatz f\u00fcr die Erwartungen an die Einreichung der technischen Dokumentation durch die Hersteller zu entwickeln. Zugleich weist Team-NB darauf hin, dass es nicht auszuschlie\u00dfen ist, dass w\u00e4hrend einer Bewertung der technischen Dokumentation weitere, im Leitfaden nicht aufgef\u00fchrte, Unterlagen\/Informationen als Teil der technischen Bewertung vorgelegt werden m\u00fcssen. Dar\u00fcber hinaus beh\u00e4lt sich jede benannte Stelle vor, zus\u00e4tzliche Informationen anzufordern.<\/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>Team-NB aktualisiert den Leitfaden zur Einreichung der Technischen Dokumentation f\u00fcr Medizinprodukte 2. Mai 2023 Am 19. April 2023 ver\u00f6ffentlichte the European Association of Medical devices Notified Bodies, kurz Team-NB, Version 2 der Stellungnahme \u201cBest Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017\/745\u201d. Der Leitfaden [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":7851,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33,11],"tags":[],"class_list":["post-7795","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\/7795","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=7795"}],"version-history":[{"count":26,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/7795\/revisions"}],"predecessor-version":[{"id":7857,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/7795\/revisions\/7857"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media\/7851"}],"wp:attachment":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media?parent=7795"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/categories?post=7795"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/tags?post=7795"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}