{"id":9313,"date":"2024-03-11T10:13:55","date_gmt":"2024-03-11T09:13:55","guid":{"rendered":"https:\/\/scc-medical-devices.com\/?p=9313"},"modified":"2024-05-14T13:54:44","modified_gmt":"2024-05-14T11:54:44","slug":"harmonisierte-normen-fuer-medizinprodukte-und-in-virto-diagnostika-weitere-aenderungen-der-durchfuehrungsbeschluesse-ec-2024-815-and-ec-2024-817","status":"publish","type":"post","link":"https:\/\/scc-medical-devices.com\/de\/harmonisierte-normen-fuer-medizinprodukte-und-in-virto-diagnostika-weitere-aenderungen-der-durchfuehrungsbeschluesse-ec-2024-815-and-ec-2024-817\/","title":{"rendered":"Harmonisierte Normen f\u00fcr Medizinprodukte und In-virto-Diagnostika: Weitere \u00c4nderungen der Durchf\u00fchrungsbeschl\u00fcsse (EC) 2024\/815 and (EC) 2024\/817"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"9313\" class=\"elementor elementor-9313 elementor-9289\" 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\">Harmonisierte Normen f\u00fcr Medizinprodukte und In-virto-Diagnostika: Weitere \u00c4nderungen der Durchf\u00fchrungsbeschl\u00fcsse (EC) 2024\/815 and (EC) 2024\/817<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f61470c elementor-widget__width-initial elementor-widget elementor-widget-text-editor\" data-id=\"f61470c\" 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>11. M\u00e4rz 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-491bc8e elementor-widget elementor-widget-text-editor\" data-id=\"491bc8e\" 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<h3>Harmonisierte Normen f\u00fcr Medizinprodukte: Weitere \u00c4nderung des Durchf\u00fchrungsbeschlusses (EU) 2021\/1182<\/h3>\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-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>Am 8. M\u00e4rz 2024 erschien im Amtsblatt der Europ\u00e4ischen Union der <a href=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/OJ_L_202400815_DE_TXT.pdf\" target=\"_blank\" rel=\"noopener\">Durchf\u00fchrungsbeschluss (EU) 2024\/815<\/a> der Kommission vom 6. M\u00e4rz 2024 zur \u00c4nderung des Durchf\u00fchrungsbeschlusses (EU) 2021\/1182 hinsichtlich harmonisierter Normen f\u00fcr medizinische Handschuhe zum einmaligen Gebrauch, die biologische Beurteilung von Medizinprodukten, die Sterilisation von Produkten f\u00fcr die Gesundheitsf\u00fcrsorge, Verpackungen f\u00fcr in der Endverpackung zu sterilisierende Medizinprodukte und die Aufbereitung von Produkten f\u00fcr die Gesundheitsf\u00fcrsorge.<\/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-9616ea1 elementor-widget elementor-widget-text-editor\" data-id=\"9616ea1\" 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>Insgesamt wurden vier neue Referenzen zu der bestehenden Liste der harmonisierten Normen hinzugef\u00fcgt und im Zuge dessen vier bestehende Referenzen \u00fcberarbeitet:<\/p><ul><li><strong>EN 455-3:2023<\/strong> Medical gloves for single use &#8211; Part 3: Requirements and testing for biological evaluation<\/li><li><strong>EN ISO 10993-15:2023<\/strong> Biological evaluation of medical devices &#8211; Part 15: Identification and quantification of degradation products from metals and alloys (ISO 10993-15:2019)<\/li><li><strong>EN ISO 10993-17:2023<\/strong> Biological evaluation of medical devices &#8211; Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)<\/li><li><strong>EN ISO 10993-18:2020<\/strong> Biological evaluation of medical devices &#8211; Part 18: Chemical characterization of medical device materials within a risk management process (ISO 10993-18:2020); EN ISO 10993-18:2020\/A1:2023<\/li><li><strong>EN ISO 11137-2:2015<\/strong> Sterilization of health care products &#8211; Radiation &#8211; Part 2: Establishing the sterilization dose (ISO 11137-2:2013); EN ISO 11137-2:2015\/A1:2023<\/li><li><strong>EN ISO 11607-1:2020<\/strong> Packaging for terminally sterilized medical devices &#8211; Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); EN ISO 11607-1:2020\/A1:2023<\/li><li><strong>EN ISO 11607-2:2020<\/strong> Packaging for terminally sterilized medical devices &#8211; Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); EN ISO 11607-2:2020\/A1:2023<\/li><li><strong>EN ISO 17664-2:2023 <\/strong>Processing of health care products &#8211; Information to be provided by the medical device manufacturer for the processing of medical devices &#8211; Part 2: Non-critical medical devices (ISO 17664-2:2021)<\/li><\/ul><p>Insgesamt gibt es 25 harmonisierte Normen im Rahmen der MDR.<\/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<section data-particle_enable=\"false\" data-particle-mobile-disabled=\"false\" class=\"elementor-section elementor-inner-section elementor-element elementor-element-f531230 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f531230\" 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-f8614a2\" data-id=\"f8614a2\" 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-6d3d794 elementor-widget elementor-widget-text-editor\" data-id=\"6d3d794\" 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<h3>Harmonisierte Normen f\u00fcr In-vitro-Diagnostika: Weitere \u00c4nderung des Durchf\u00fchrungsbeschlusses (EU) 2021\/1195<\/h3>\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-82fc0eb elementor-widget elementor-widget-text-editor\" data-id=\"82fc0eb\" 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>Der <a href=\"https:\/\/scc-medical-devices.com\/wp-content\/uploads\/OJ-L_202400817-DE-TXT.pdf\" target=\"_blank\" rel=\"noopener\">Durchf\u00fchrungsbeschluss (EU) 2024\/817<\/a> der Kommission vom 6. M\u00e4rz 2024 zur \u00c4nderung des Durchf\u00fchrungsbeschlusses (EU) 2021\/1195 hinsichtlich harmonisierter Normen f\u00fcr die Sterilisation von Produkten f\u00fcr die Gesundheitsf\u00fcrsorge und Verpackungen f\u00fcr in der Endverpackung zu sterilisierende Medizinprodukte ist am 8. M\u00e4rz 2024 im Amtsblatt der Europ\u00e4ischen Union ver\u00f6ffentlicht worden. \u00dcber den Entwurf dieses Durchf\u00fchrungsbeschlusses wurde im BAH um Vier 14\/2024 vom 19. Januar 2024 berichtet.<\/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-b99c416 elementor-widget elementor-widget-text-editor\" data-id=\"b99c416\" 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>Drei Referenzen der Liste der harmonisierten Normen im Rahmen der IVDR wurden damit \u00fcberarbeitet:<\/p><ul><li><strong>EN ISO 11137-2:2015<\/strong> Sterilization of health care products &#8211; Radiation &#8211; Part 2: Establishing the sterilization dose (ISO 11137-2:2013); EN ISO 11137-2:2015\/A1:2023<\/li><li><strong>EN ISO 11607-1:2020<\/strong> Packaging for terminally sterilized medical devices &#8211; Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); EN ISO 11607-1:2020\/A1:2023<\/li><li><strong>EN ISO 11607-2:2020 <\/strong>Packaging for terminally sterilized medical devices &#8211; Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)<strong>; <\/strong>EN ISO 11607-2:2020\/A1:2023<\/li><\/ul><p>Insgesamt gibt es 13 harmonisierte Normen im Rahmen der IVDR.<\/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>Harmonisierte Normen gem\u00e4\u00df EU MDR \/ IVDR: EK ver\u00f6ffentlicht neue Durchf\u00fchrungsbeschl\u00fcsse (EU) 2024\/815 und (EU) 2024\/817<\/p>\n","protected":false},"author":3,"featured_media":9291,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[33,11],"tags":[],"class_list":["post-9313","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\/9313","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=9313"}],"version-history":[{"count":6,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/9313\/revisions"}],"predecessor-version":[{"id":9325,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/posts\/9313\/revisions\/9325"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media\/9291"}],"wp:attachment":[{"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/media?parent=9313"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/categories?post=9313"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/scc-medical-devices.com\/de\/wp-json\/wp\/v2\/tags?post=9313"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}