{"id":7360,"date":"2024-04-04T15:08:00","date_gmt":"2024-04-04T13:08:00","guid":{"rendered":"https:\/\/www.mirdetect.de\/?p=7360"},"modified":"2025-10-21T12:59:36","modified_gmt":"2025-10-21T10:59:36","slug":"zertifizierung-ivdr","status":"publish","type":"post","link":"https:\/\/www.mirdetect.de\/en\/zertifizierung-ivdr\/","title":{"rendered":"Certification according to IVDR"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"7360\" class=\"elementor elementor-7360\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-261fa46 e-flex e-con-boxed e-con e-parent\" data-id=\"261fa46\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-a5b5b52 elementor-widget elementor-widget-image\" data-id=\"a5b5b52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<a href=\"https:\/\/www.mirdetect.de\/wp-content\/uploads\/2024\/04\/mirdetect_IVDR_1.png\" data-elementor-open-lightbox=\"yes\" data-elementor-lightbox-title=\"mirdetect_IVDR_1\" data-e-action-hash=\"#elementor-action%3Aaction%3Dlightbox%26settings%3DeyJpZCI6NzM2MiwidXJsIjoiaHR0cHM6XC9cL3d3dy5taXJkZXRlY3QuZGVcL3dwLWNvbnRlbnRcL3VwbG9hZHNcLzIwMjRcLzA0XC9taXJkZXRlY3RfSVZEUl8xLnBuZyJ9\">\n\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"664\" height=\"941\" src=\"https:\/\/www.mirdetect.de\/wp-content\/uploads\/2024\/04\/mirdetect_IVDR_1.png\" class=\"attachment-large size-large wp-image-7362\" alt=\"Zertifikat\" srcset=\"https:\/\/www.mirdetect.de\/wp-content\/uploads\/2024\/04\/mirdetect_IVDR_1.png 664w, https:\/\/www.mirdetect.de\/wp-content\/uploads\/2024\/04\/mirdetect_IVDR_1-212x300.png 212w, https:\/\/www.mirdetect.de\/wp-content\/uploads\/2024\/04\/mirdetect_IVDR_1-8x12.png 8w\" sizes=\"(max-width: 664px) 100vw, 664px\" \/>\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t\t\t\t\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-e9be6c6 elementor-widget elementor-widget-text-editor\" data-id=\"e9be6c6\" 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<div class=\"grid-x grid-padding-y\"><div class=\"cell small-12 medium-auto\"><div class=\"text\"><p><strong>Bremerhaven, April 2024<\/strong> - The mir|detect GmbH provides the successful <strong data-start=\"146\" data-end=\"169\">IVDR certification<\/strong> their <strong data-start=\"176\" data-end=\"190\">M371-Test<\/strong> announced. The company thus officially fulfils all requirements of the European In Vitro Diagnostics Regulation (Regulation (EU) 2017\/746 IVDR). The M371-Test is a CE-IVD-certified blood test for the precise and non-invasive detection of testicular cancer.<\/p><\/div><\/div><\/div><div id=\"stacks_out_2623\" class=\"stacks_out\"><div id=\"stacks_in_2623\" class=\"stacks_in uk_co_doobox_responsiveshim_stack\">\u00a0<\/div><\/div>\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-5cdb315 elementor-widget elementor-widget-heading\" data-id=\"5cdb315\" 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<h5 class=\"elementor-heading-title elementor-size-default\">Important milestone for molecular diagnostics<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-056b992 elementor-widget elementor-widget-text-editor\" data-id=\"056b992\" 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 data-start=\"518\" data-end=\"789\">Certification in accordance with the IVDR is considered one of the most demanding regulatory procedures in the European medical device market. It confirms that the <strong data-start=\"676\" data-end=\"689\">M371-Test<\/strong> fulfils the highest standards in terms of quality, safety and clinical performance.<\/p><p data-start=\"791\" data-end=\"1124\">\"The IVDR certification marks a decisive step in the development of mir|detect,\" said Dr Nina Winter, CEO at <strong data-start=\"933\" data-end=\"947\">mir|detect<\/strong>. \"It underlines our claim to offer laboratories and doctors a scientifically sound, reliable and compliant solution for the diagnosis of testicular cancer.\"<\/p><p data-start=\"1898\" data-end=\"2175\">With the certification, the <strong data-start=\"1937\" data-end=\"1950\">M371-Test<\/strong> The official authorisation for clinical use in the European Union. It ensures that the product fulfils the strictest requirements for clinical evidence, performance evaluation and quality management.<\/p><p data-start=\"2177\" data-end=\"2357\">This counts <strong data-start=\"2189\" data-end=\"2203\">mir|detect<\/strong> is one of the few companies in Europe to have successfully completed IVDR certification for a microRNA-based liquid biopsy test.<\/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\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Bremerhaven, April 2024 &#8211;\u00a0Die mir|detect GmbH gibt die erfolgreiche IVDR-Zertifizierung ihres M371-Tests bekannt. Damit erf\u00fcllt das Unternehmen offiziell alle Anforderungen der Europ\u00e4ischen In-vitro-Diagnostika-Verordnung (VO (EU) 2017\/746 IVDR). Der M371-Test ist ein CE-IVD-zertifizierter Bluttest zur pr\u00e4zisen und nicht-invasiven Erkennung von Hodenkrebs. \u00a0 Wichtiger Meilenstein f\u00fcr die molekulare Diagnostik Die Zertifizierung nach der IVDR gilt als eines [&hellip;]<\/p>","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"content-type":"","footnotes":"","_wp_rev_ctl_limit":""},"categories":[1],"tags":[],"class_list":["post-7360","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Zertifizierung nach IVDR - mir|detect<\/title>\n<meta name=\"description\" content=\"Der M371-Test von mir|detect ist nach IVDR zertifiziert und erm\u00f6glicht eine nicht-invasive Diagnostik und \u00dcberwachung von Hodenkrebs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.mirdetect.de\/en\/zertifizierung-ivdr\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Zertifizierung nach IVDR - mir|detect\" \/>\n<meta property=\"og:description\" content=\"Der M371-Test von mir|detect ist nach IVDR zertifiziert und erm\u00f6glicht eine nicht-invasive Diagnostik und \u00dcberwachung von Hodenkrebs.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.mirdetect.de\/en\/zertifizierung-ivdr\/\" \/>\n<meta property=\"og:site_name\" content=\"mir|detect\" \/>\n<meta property=\"article:published_time\" content=\"2024-04-04T13:08:00+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-10-21T10:59:36+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.mirdetect.de\/wp-content\/uploads\/2024\/04\/mirdetect_IVDR_1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"664\" \/>\n\t<meta property=\"og:image:height\" content=\"941\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"21HAVN-MF\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"21HAVN-MF\" \/>\n\t<meta name=\"twitter:label2\" content=\"Estimated reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/zertifizierung-ivdr\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/zertifizierung-ivdr\\\/\"},\"author\":{\"name\":\"21HAVN-MF\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#\\\/schema\\\/person\\\/02a29c0e15eb6e446fc0eb15d9f31e75\"},\"headline\":\"Zertifizierung nach IVDR\",\"datePublished\":\"2024-04-04T13:08:00+00:00\",\"dateModified\":\"2025-10-21T10:59:36+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/zertifizierung-ivdr\\\/\"},\"wordCount\":198,\"publisher\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/zertifizierung-ivdr\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.mirdetect.de\\\/wp-content\\\/uploads\\\/2024\\\/04\\\/mirdetect_IVDR_1.png\",\"articleSection\":[\"News\"],\"inLanguage\":\"en-GB\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.mirdetect.de\\\/zertifizierung-ivdr\\\/\",\"url\":\"https:\\\/\\\/www.mirdetect.de\\\/zertifizierung-ivdr\\\/\",\"name\":\"Zertifizierung nach IVDR - 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