{"id":18918,"date":"2025-11-27T15:18:00","date_gmt":"2025-11-27T14:18:00","guid":{"rendered":"https:\/\/sefiro.de\/?p=18918"},"modified":"2025-12-03T15:23:57","modified_gmt":"2025-12-03T14:23:57","slug":"die-ersten-vier-module-von-eudamed-muessen-ab-dem-28-mai-2026-verpflichtend-verwendet-werden","status":"publish","type":"post","link":"https:\/\/sefiro.de\/en\/2025\/11\/27\/die-ersten-vier-module-von-eudamed-muessen-ab-dem-28-mai-2026-verpflichtend-verwendet-werden\/","title":{"rendered":"The first four modules of EUDAMED must be used on a mandatory basis from May 28, 2026."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"18918\" class=\"elementor elementor-18918\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-1319202a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1319202a\" 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-6a3aea03\" data-id=\"6a3aea03\" 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-626760db elementor-widget elementor-widget-text-editor\" data-id=\"626760db\" 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>EUDAMED (European database for medical devices) is activated. In accordance with the transitional provisions laid down in Regulation (EU) 2024\/1860, Commission Decision (EU) 2025\/2371 (published in the Official Journal L on November 27, 2025) triggers a transitional period of six months.<\/p><p>The following EUDAMED modules must be used from May 28, 2026:<\/p><p>a) the electronic system for the registration of economic operators,<\/p><p>b) the UDI database and the electronic system for the registration of products,<\/p><p>c) the electronic system for notified bodies and certificates,<\/p><p>d) the electronic system for market surveillance.<\/p><p>Source:<\/p><p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/DE\/TXT\/?uri=OJ:L_202502371\" target=\"_blank\" rel=\"noopener\"><em>Beschluss (EU) 2025\/2371 der Kommission vom 26.\u00a0November 2025 \u00fcber die Mitteilung \u00fcber die Funktionalit\u00e4t bestimmter elektronischer Systeme in der Europ\u00e4ischen Datenbank f\u00fcr Medizinprodukte und die Erf\u00fcllung ihrer funktionalen Spezifikationen gem\u00e4\u00df Artikel\u00a034 Absatz\u00a01 der Verordnung (EU)\u00a02017\/745 des Europ\u00e4ischen Parlaments und des Rates<\/em><\/a><\/p><p><!-- [if gte mso 9]><xml>\n <o:OfficeDocumentSettings>\n  <o:AllowPNG\/>\n <\/o:OfficeDocumentSettings>\n<\/xml><![endif]--><!-- [if gte mso 9]><xml>\n <w:WordDocument>\n  <w:View>Normal<\/w:View>\n  <w:Zoom>0<\/w:Zoom>\n  <w:TrackMoves\/>\n  <w:TrackFormatting\/>\n  <w:HyphenationZone>21<\/w:HyphenationZone>\n  <w:PunctuationKerning\/>\n  <w:ValidateAgainstSchemas\/>\n  <w:SaveIfXMLInvalid>false<\/w:SaveIfXMLInvalid>\n  <w:IgnoreMixedContent>false<\/w:IgnoreMixedContent>\n  <w:AlwaysShowPlaceholderText>false<\/w:AlwaysShowPlaceholderText>\n  <w:DoNotPromoteQF\/>\n  <w:LidThemeOther>DE<\/w:LidThemeOther>\n  <w:LidThemeAsian>X-NONE<\/w:LidThemeAsian>\n  <w:LidThemeComplexScript>X-NONE<\/w:LidThemeComplexScript>\n  <w:Compatibility>\n   <w:BreakWrappedTables\/>\n   <w:SnapToGridInCell\/>\n   <w:WrapTextWithPunct\/>\n   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Locked=\"false\" Priority=\"65\" Name=\"Medium List 1 Accent 1\"\/>\n  <w:LsdException Locked=\"false\" SemiHidden=\"true\" Name=\"Revision\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"34\" QFormat=\"true\"\n   Name=\"List Paragraph\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"29\" QFormat=\"true\" Name=\"Quote\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"30\" QFormat=\"true\"\n   Name=\"Intense Quote\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"66\" Name=\"Medium List 2 Accent 1\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"67\" Name=\"Medium Grid 1 Accent 1\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"68\" Name=\"Medium Grid 2 Accent 1\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"69\" Name=\"Medium Grid 3 Accent 1\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"70\" Name=\"Dark List Accent 1\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"71\" Name=\"Colorful Shading Accent 1\"\/>\n  <w:LsdException Locked=\"false\" 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Locked=\"false\" Priority=\"71\" Name=\"Colorful Shading Accent 6\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"72\" Name=\"Colorful List Accent 6\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"73\" Name=\"Colorful Grid Accent 6\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"19\" QFormat=\"true\"\n   Name=\"Subtle Emphasis\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"21\" QFormat=\"true\"\n   Name=\"Intense Emphasis\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"31\" QFormat=\"true\"\n   Name=\"Subtle Reference\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"32\" QFormat=\"true\"\n   Name=\"Intense Reference\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"33\" QFormat=\"true\" Name=\"Book Title\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"37\" SemiHidden=\"true\"\n   UnhideWhenUsed=\"true\" Name=\"Bibliography\"\/>\n  <w:LsdException Locked=\"false\" Priority=\"39\" SemiHidden=\"true\"\n   UnhideWhenUsed=\"true\" QFormat=\"true\" Name=\"TOC 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5.4pt;\n\tmso-para-margin-top:0cm;\n\tmso-para-margin-right:0cm;\n\tmso-para-margin-bottom:8.0pt;\n\tmso-para-margin-left:0cm;\n\tline-height:107%;\n\tmso-pagination:widow-orphan;\n\tfont-size:11.0pt;\n\tfont-family:\"Calibri\",sans-serif;\n\tmso-ascii-font-family:Calibri;\n\tmso-ascii-theme-font:minor-latin;\n\tmso-hansi-font-family:Calibri;\n\tmso-hansi-theme-font:minor-latin;\n\tmso-bidi-font-family:\"Times New Roman\";\n\tmso-bidi-theme-font:minor-bidi;\n\tmso-fareast-language:EN-US;}\n<\/style>\n<![endif]--><\/p><p>\u00a0<\/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>Die EUDAMED (europ\u00e4ische Datenbank f\u00fcr Medizinprodukte) wird aktiviert. Gem\u00e4\u00df den in der Verordnung (EU) 2024\/1860 festgelegten \u00dcbergangs-bestimmungen l\u00f6st der Beschluss (EU) 2025\/2371 der Kommission (ver\u00f6ffentlicht im Amtsblatt L vom 27.11.2025) eine \u00dcbergangsfrist von 6 Monaten aus. Folgende EUDAMED-Module sind ab 28.05.2026 verpflichtend zu verwenden: a) das elektronische System f\u00fcr die Registrierung von Wirtschaftsakteuren, b) die &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/sefiro.de\/en\/2025\/11\/27\/die-ersten-vier-module-von-eudamed-muessen-ab-dem-28-mai-2026-verpflichtend-verwendet-werden\/\"> <span class=\"screen-reader-text\">The first four modules of EUDAMED must be used on a mandatory basis from May 28, 2026.<\/span> Read More &raquo;<\/a><\/p>","protected":false},"author":3,"featured_media":2531,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[107,109],"tags":[],"class_list":["post-18918","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-gesetze-richtlinien-non-food","category-news-meldeportale-datenbanken"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Die ersten vier Module von EUDAMED m\u00fcssen ab dem 28. 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