{"id":3935,"date":"2026-11-01T11:33:23","date_gmt":"2026-11-01T11:33:23","guid":{"rendered":"https:\/\/nano-test.de\/?p=3935"},"modified":"2026-11-06T06:06:31","modified_gmt":"2026-11-06T06:06:31","slug":"laboruntersuchungsanforderungen-gemaess-mdr-aktuelle-testuebersicht-fuer-hersteller","status":"publish","type":"post","link":"https:\/\/nano-test.de\/en\/2026\/11\/01\/laboruntersuchungsanforderungen-gemaess-mdr-aktuelle-testuebersicht-fuer-hersteller\/","title":{"rendered":"Laboratory testing requirements under the MDR: Up-to-date overview of tests for manufacturers"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3935\" class=\"elementor elementor-3935\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ded200f ts-col-stretched-none ts-bg-color-over-image elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ded200f\" 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-9a10676 ts-bg-color-over-image\" data-id=\"9a10676\" 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-f84b6fd elementor-widget elementor-widget-text-editor\" data-id=\"f84b6fd\" 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><span style=\"color: #000000;\">The importance of MDR and laboratory tests<\/span><\/h3><p><span style=\"color: #000000;\">F\u00fcr Hersteller von Medizinprodukten ist die <a href=\"https:\/\/eur-lex.europa.eu\/eli\/reg\/2017\/745\/oj\/eng\">MDR-Verordnung<\/a> (Medical Device Regulation \u2013 Medizinprodukteverordnung) der Europ\u00e4ischen Union einer der Grundpfeiler f\u00fcr die Bereitstellung sicherer und wirksamer Produkte. Die MDR schreibt nicht nur die Dokumentation der Leistung des Produkts vor, sondern auch die Dokumentation seiner biologischen Sicherheit und seiner Auswirkungen auf die Gesundheit der Patienten.<\/span><\/p><p><span style=\"color: #000000;\">In this context, laboratory tests are the focus of MDR compliance. Manufacturers need to create a comprehensive test plan to demonstrate the security of their devices, minimize risks and ensure smooth market access.<\/span><\/p><h3><span style=\"color: #000000;\">Test categories prescribed according to MDR<\/span><\/h3><p><span style=\"color: #000000;\">The MDR prescribes various tests depending on the class and purpose of medical devices. These tests can be divided into four main categories:<\/span><\/p><h4><span style=\"color: #000000;\">1. Biological assessment tests (ISO 10993 series)<\/span><\/h4><ul><li><span style=\"color: #000000;\">Cytotoxicity Tests: Measure the toxic effect at the cell level.<\/span><\/li><li><span style=\"color: #000000;\">Sensitization tests: Assess the risk of allergic reactions.<\/span><\/li><li><span style=\"color: #000000;\">Hemolysis Tests: Check if the blood cells are damaged.<\/span><\/li><li><span style=\"color: #000000;\"><a href=\"https:\/\/nano-test.de\/en\/2025\/12\/05\/biokompatibilitaetstests-fuer-medizinische-implantate\/\">Implantationstests<\/a>: Messen die Wirkung des Implantats im K\u00f6rper.<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">2. Chemical Analysis and Risk Assessment<\/span><\/h4><ul><li><span style=\"color: #000000;\">Analysis of potentially toxic substances in the materials of the device<\/span><\/li><li><span style=\"color: #000000;\">Identification of chemicals that can harm human health<\/span><\/li><li><span style=\"color: #000000;\">Creation of a security profile based on a risk assessment<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">3. Mechanical and Functional Tests<\/span><\/h4><ul><li><span style=\"color: #000000;\">Device durability and performance tests<\/span><\/li><li><span style=\"color: #000000;\">Lifetime Simulations<\/span><\/li><li><span style=\"color: #000000;\">Identification of possible failures during use<\/span><\/li><\/ul><h4><span style=\"color: #000000;\">4. Sterilization and Microbiological Tests<\/span><\/h4><ul><li><span style=\"color: #000000;\">Validation of sterilization methods<\/span><\/li><li><span style=\"color: #000000;\">Microbial Contamination Tests<\/span><\/li><li><span style=\"color: #000000;\">Compliance of the device with hygiene and safety standards<\/span><\/li><\/ul><h3>MDR test plan: Requirements depending on device class<\/h3><p><span style=\"color: #000000;\">The following table summarizes which tests manufacturers need to plan depending on the device class:<\/span><\/p><h3><span style=\"color: #000000;\">Selection of the laboratory and test procedure<\/span><\/h3><p><span style=\"color: #000000;\">Im Rahmen der MDR ist es von entscheidender Bedeutung, dass die Tests in zuverl\u00e4ssigen und akkreditierten Labors durchgef\u00fchrt werden. Diese Labors arbeiten in der Regel gem\u00e4\u00df den Normen ISO\/IEC 17025 und <a href=\"https:\/\/www.iso.org\/standard\/59752.html\">ISO 13485<\/a>.<\/span><\/p><table><thead><tr><th><span style=\"color: #000000;\">Device class<\/span><\/th><th><span style=\"color: #000000;\">Mandatory Tests<\/span><\/th><th><span style=\"color: #000000;\">Reference Standards<\/span><\/th><\/tr><\/thead><tbody><tr><td><span style=\"color: #000000;\">Class I<\/span><\/td><td><span style=\"color: #000000;\">Cytotoxicity, Mechanical Testing<\/span><\/td><td><span style=\"color: #000000;\">ISO 10993, ISO 13485<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">Class IIa<\/span><\/td><td><span style=\"color: #000000;\">Biological Tests, Sterilization<\/span><\/td><td><span style=\"color: #000000;\">ISO 10993, EN 556<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">Class IIb<\/span><\/td><td><span style=\"color: #000000;\">Chemical Analysis, Mechanical Tests, Sterilization<\/span><\/td><td><span style=\"color: #000000;\">ISO 10993, ISO 11737<\/span><\/td><\/tr><tr><td><span style=\"color: #000000;\">Class III<\/span><\/td><td><span style=\"color: #000000;\">Complete biological, mechanical, sterilization and risk analysis<\/span><\/td><td><span style=\"color: #000000;\">ISO 10993, ISO 1113<\/span><\/td><\/tr><\/tbody><\/table><h4><span style=\"color: #000000;\">What should be considered in the test procedure?<\/span><\/h4><ul><li><span style=\"color: #000000;\">The test plan must be created according to the device class.<\/span><span style=\"color: #000000;\"><br><\/span><\/li><li><span style=\"color: #000000;\">An accredited laboratory must be selected.<\/span><span style=\"color: #000000;\"><br><\/span><\/li><li><span style=\"color: #000000;\">The test results must be fully documented in the technical documentation of the MDR.<\/span><span style=\"color: #000000;\"><br><\/span><\/li><li><span style=\"color: #000000;\">These steps protect the manufacturer in possible audits and market access procedures.<\/span><\/li><\/ul><p><span style=\"color: #000000;\">We are happy to support you in the MDR compliance of your medical devices. Contact us.<\/span><\/p><p><span style=\"color: #000000;\">info@nano-test.de<\/span><\/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>Die Bedeutung von MDR und Labortests F\u00fcr Hersteller von Medizinprodukten ist die MDR-Verordnung (Medical Device Regulation \u2013 Medizinprodukteverordnung) der Europ\u00e4ischen Union einer der Grundpfeiler f\u00fcr die Bereitstellung sicherer und wirksamer Produkte. Die MDR schreibt nicht nur die Dokumentation der Leistung des Produkts vor, sondern auch die Dokumentation seiner biologischen Sicherheit und seiner Auswirkungen auf die \u2026 <a href=\"https:\/\/nano-test.de\/en\/2026\/11\/01\/laboruntersuchungsanforderungen-gemaess-mdr-aktuelle-testuebersicht-fuer-hersteller\/\" class=\"more-link\" title=\"Continue reading &amp;lt;span class=\" screen-reader-text>Laboruntersuchungsanforderungen gem\u00e4\u00df MDR: Aktuelle Test\u00fcbersicht f\u00fcr Hersteller\u201c&gt;Continue reading <span class=\"screen-reader-text\">Laboratory testing requirements under the MDR: Up-to-date overview of tests for manufacturers<\/span><\/a><\/p>\n","protected":false},"author":4,"featured_media":3936,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3935","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medizinprodukt-blog"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Laboruntersuchungen nach MDR: Test\u00fcbersicht | Nano-Test\u00ae<\/title>\n<meta name=\"description\" content=\"Laboruntersuchungen nach MDR: Welche Tests Hersteller von Medizinprodukten ben\u00f6tigen Biokompatibilit\u00e4t, Mikrobiologie und Chemie \u00dcberblick.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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