{"id":15167,"date":"2022-09-27T09:00:39","date_gmt":"2022-09-27T14:00:39","guid":{"rendered":"https:\/\/www.coleparmer.com\/blog\/?p=15167"},"modified":"2022-12-08T01:33:35","modified_gmt":"2022-12-08T07:33:35","slug":"zeptometrix-in-vitro-diagnostic-regulation-ivdr-certification","status":"publish","type":"post","link":"https:\/\/www.coleparmer.com\/blog\/zeptometrix-in-vitro-diagnostic-regulation-ivdr-certification\/","title":{"rendered":"ZeptoMetrix Takes First Step to In Vitro Diagnostic Regulation (IVDR) Certification"},"content":{"rendered":"<h2>IVDR regulation came into force May, 2022<\/h2>\n<p>ZeptoMetrix\u00ae has successfully completed its first EU Quality Management System Audit from British Standards Institution BSI, NB 2797, one of the notified bodies under the new In Vitro Diagnostics Regulation (IVDR). The certification applies to the portfolio of ZeptoMetrix NATtrol\u2122 control products that are the industry\u2019s preferred standard for molecular diagnostics testing and are supplied ready-to-use as independent third-party <a href=\"\/tech-article\/reduce-errors-and-increase-confidence-in-testing-with-quality-controls-the-science-of-real-life\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">quality control<\/a> materials.<\/p>\n<p>The IVDR is mandatory for any manufacturer of in vitro diagnostic devices (IVDs) to issue declarations of conformity, CE mark their products and to get them recertified in compliance with the new regulation.<\/p>\n<h2>ZeptoMetrix transition from IVDD to IVDR<\/h2>\n<p>ZeptoMetrix is on-track to the full and timely transition from the In Vitro Diagnostics Directive (IVDD) to the IVDR. Our customers can be assured of continued availability of our CE-IVD marked portfolio along with our commitment to ongoing new product innovations.<\/p>\n<p>Requirements of the IVDR regulation came into force on May 26, 2022. ZeptoMetrix CE-marked devices lawfully placed on the market in accordance with IVDD (directive 98\/79\/EC) prior to the date of application by virtue of a valid certificate may continue to be made available on the market until May 26, 2027.<\/p>\n<p>For more information on ZeptoMetrix and NATtrol products, visit <a href=\"https:\/\/www.zeptometrix.com\/\" data-wplink-edit=\"true\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.zeptometrix.com<\/a><\/p>\n<h2>Related Articles<\/h2>\n<p><a href=\"\/blog\/2022\/07\/26\/zeptometrix-launches-flu-rsv-sars-cov-2-external-run-quality-control\/\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">ZeptoMetrix\u00ae Launches Flu\/RSV\/SARS-CoV-2 External Run Quality Control<\/a><\/p>\n<p><a href=\"\/blog\/2022\/08\/09\/zeptometrix-nattrol-bacteriophage-ms2-quantitative-stock-solution\/\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">ZeptoMetrix\u00ae Launches NATtrol\u2122 Bacteriophage MS2 Quantitative Stock Solution<\/a><\/p>\n<p><a href=\"\/blog\/\" rel=\"nofollow noopener noreferrer\" target=\"_blank\"><img loading=\"lazy\" decoding=\"async\" class=\"aligncenter wp-image-12311 size-full\" src=\"https:\/\/www.coleparmer.com\/blog\/wp-content\/uploads\/2020\/09\/CP_MA_Bottom_Blog-reminder-for-blog.jpg\" alt=\"Get the lastest blog posts delivered to your email - sign up today\" width=\"600\" height=\"100\"><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>IVDR regulation came into force May, 2022 ZeptoMetrix\u00ae has successfully completed its first EU Quality Management System Audit from British Standards Institution BSI, NB 2797, one of the notified bodies under the new In Vitro&#8230;<\/p>\n","protected":false},"author":20,"featured_media":15168,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":["post-15167","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-for-the-lab"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ZeptoMetrix Takes First Step to In Vitro Diagnostic Regulation (IVDR) Certification | Antylia Scientific Blog<\/title>\n<meta name=\"description\" content=\"ZeptoMetrix is on-track to transition from the IVDD to the IVDR with it&#039;s first completed audit from the BSI for NatTrol products.\" \/>\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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