{"id":8621,"date":"2025-04-14T15:44:05","date_gmt":"2025-04-14T15:44:05","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8621"},"modified":"2025-04-15T15:47:48","modified_gmt":"2025-04-15T15:47:48","slug":"key-deadlines-and-compliance-requirements-for-ivdr-transition","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/key-deadlines-and-compliance-requirements-for-ivdr-transition\/","title":{"rendered":"Navigating the Final Countdown: Key Deadlines and Compliance Requirements for IVDR Transition"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8621\" class=\"elementor elementor-8621\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" 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-4264d41\" data-id=\"4264d41\" 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<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\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-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\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-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2025\/04\/14\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tApril 14, 2025\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Navigating the Final Countdown: Key Deadlines and Compliance Requirements for IVDR Transition<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-35270e5 elementor-widget elementor-widget-text-editor\" data-id=\"35270e5\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Understanding the EU IVDR Compliance Deadlines<\/strong><\/p><p>The EU In Vitro Diagnostic Regulation (IVDR) (EU 2017\/746), which went into effect on May 26, \u00a02022, replaces the In Vitro Diagnostic Directive 98\/79\/EC (IVDD). It introduces stricter requirements, including new risk classifications, increased clinical evidence requirements, and post-market surveillance. Compliance with IVDR is being phased in, with specific deadlines that manufacturers must meet in order to maintain market access.<\/p><p>With the IVDR, the European Commission introduced a pragmatic approach to implementing it, announcing new rules and giving more time for manufacturers of legacy devices (those with existing certification under the IVDD) to transition to the new requirements without compromising safety and mitigating the risk of product shortages.<\/p><p>The initial transition periods were staggered, with high-risk IVDs having a shorter period than lower-risk IVDs.\u00a0Article 110 of the IVDR provided a bridge for IVD devices that were legally sold under the IVDD before May 26, 2022 and devices that were sold after May 26, 2022 but had a valid certificate as stated in Article 110(2), which could continue to be placed on the market or put into service after the IVDR&#8217;s application date, provided those devices remained compliant with the IVDD and had no significant changes in design or intended purpose. The IVDR obligations concerning post-market surveillance, vigilance, and the registration of economic operators and devices take precedence over and replace the equivalent stipulations in the IVDD.<\/p><p>On July 9, 2024, Regulation (EU) 2024\/1860 was formally published, officially extending the transition periods for in vitro diagnostic medical devices. Regulation (EU) 2024\/1860 not only addresses device transition but also incorporates a gradual implementation of the EUDAMED database, information requirements for supply interruptions, and revised transitional provisions for IVD medical devices.<\/p><p>Certificates that expired before the amending Regulation 2024\/1860 are considered valid only if, prior to their expiration, the manufacturer and a Notified Body had a written agreement for conformity assessment of the device or its intended replacement, or if a national Competent Authority granted a derogation under Article 54(1) of the IVDR or mandated the manufacturer to complete the conformity assessment within a specified timeframe as per Article 92(1) of the IVDR. Even if a national derogation is time-limited or a conformity assessment deadline is imposed, the device still benefits from the complete transitional period until December 31, 2027, provided the conditions outlined in Article 110(3c) of the IVDR are met, with the certificate remaining valid until that date unless it is withdrawn.<\/p><p>Under the new provisions, the additional time granted to manufacturers of IVDs depends on the type of device:<\/p><ul><li>Devices posing a high risk to patient and public health, such as\u00a0HIV or hepatitis tests (Class D), have a transition period until December 2027.<\/li><li>Devices posing a high risk to patients and\/or devices posing a moderate risk to public health,\u00a0such as\u00a0cancer tests\u00a0(Class C), have a transition period until December 2028.<\/li><li>Lower-risk\u00a0devices\u00a0(Class B, such as pregnancy tests, and Class A sterile devices, such as blood collection tubes) have a transition period until December 2029.<\/li><\/ul><p>There is no transitional period for Class A devices (except sterile devices) because these devices do not require Notified Body involvement for their assessment. Similarly, \u201cnew\u201d devices (those without an IVDD certificate or declaration of conformity) are also not covered in the transitional period. The IVDR has been in effect for these devices since May 26, 2022.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-107c5a7 elementor-widget elementor-widget-text-editor\" data-id=\"107c5a7\" 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><strong>IVDR Transition Timeline<\/strong><\/p><table width=\"636\"><tbody><tr><td width=\"180\"><p><strong>IVD Class<\/strong><\/p><\/td><td width=\"108\"><p><strong>Risk Level<\/strong><\/p><\/td><td width=\"186\"><p><strong>Original IVDR Transition Date<\/strong><\/p><\/td><td width=\"162\"><p><strong>New IVDR Transition Date<\/strong><\/p><\/td><\/tr><tr><td width=\"180\"><p>Class D<\/p><\/td><td width=\"108\"><p>High<\/p><\/td><td width=\"186\"><p>May 26, 2025<\/p><\/td><td width=\"162\"><p>Dec 31, 2027<\/p><\/td><\/tr><tr><td width=\"180\"><p>Class C<\/p><\/td><td width=\"108\"><p>Moderate<\/p><\/td><td width=\"186\"><p>May 26, 2026<\/p><\/td><td width=\"162\"><p>Dec 31, 2028<\/p><\/td><\/tr><tr><td width=\"180\"><p>Class B and Class A (sterile)<\/p><\/td><td width=\"108\"><p>Lower<\/p><\/td><td width=\"186\"><p>May 26, 2027<\/p><\/td><td width=\"162\"><p>Dec 31, 2029<\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bc68206 elementor-widget elementor-widget-image\" data-id=\"bc68206\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/thumbs\/IVDR-timeline-800x450-1-r4eg707hsjpih6l2p5f69dpwxq41rwx0igmty5kvis.png\" title=\"IVDR-timeline-800&#215;450\" alt=\"IVDR-timeline-800x450\" loading=\"lazy\" \/>\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-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" 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><strong>Impact on Manufacturers and Economic Operators<\/strong><\/p><p>The IVDR significantly impacts manufacturers by introducing a more stringent risk-based classification system, requiring increased technical documentation and mandating more rigorous post-market surveillance. These changes demand adjustments in product development, regulatory affairs, and the quality management system (QMS) for manufacturers seeking to keep and\/or place their IVDs on the European market.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ce2cfa elementor-widget elementor-widget-text-editor\" data-id=\"7ce2cfa\" 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><strong>Actionable Steps for Compliance<\/strong><\/p><p>It is critical to have a transition plan with a strategic alignment of development, testing, and regulatory approaches to the IVDR phased deadlines. Furthermore, early engagement with Notified Bodies is strongly advised to avoid potential certification delays due to the increased demand for their services.<\/p><p>The transition to the IVDR also entails increased investment in compliance, including clinical studies, post-market surveillance, and updated technical and QMS documentation, consequently increasing costs and resource allocation.<\/p><p>Economic operators (importers, distributors, and authorized representatives) must adhere to their corresponding responsibilities by the specified deadlines. Failure to comply with the requirements of the IVDR will lead to the removal of noncompliant devices from the market, potentially impacting revenue streams and patient access to critical diagnostics.<\/p><p>The IVDR transition is well underway, and manufacturers must stay ahead of compliance deadlines to ensure uninterrupted market access. Early planning, regulatory expertise, and strategic alignment with IVDR milestones are essential for success.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-06ee98e elementor-widget elementor-widget-text-editor\" data-id=\"06ee98e\" 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><strong>Sources:<\/strong><\/p><ul><li>Regulation (EU) 2017\/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98\/79\/EC and Commission Decision 2010\/227\/EU<\/li><li>Extension of the IVDR Transitional Periods. Q&amp;A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024\/1860 of 13 June 2024 amending Regulations (EU) 2017\/745 and (EU) 2017\/746 as regards a gradual roll-out of EUDAMED, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices. July 2024<\/li><li>European Commission &#8211; Press release. Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics. Brussels, 25 April 2024<\/li><li>European Commission &#8211; Press release. Commission proposes measures to improve the availability of in vitro diagnostics. Brussels, Jan 22, 2024<\/li><li><a href=\"https:\/\/euivdr.com\">https:\/\/euivdr.com<\/a><\/li><li>The European Union In Vitro Diagnostic Medical Device Regulation (IVDR). 2023 \u00a9 T\u00dcV S\u00dcD AG\/MKG\/MHS\/42.2\/en\/SG<\/li><li>DLRC EU Medical Devices IVDR 2017\/746: Transition Extension Update. Published 18th July 2024<\/li><li>Impact of (EU) 2024\/1860 on Legacy Devices &amp; Update on BSI Implementation. bsigroup.com\/Press-release<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0c7adaf\" 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-84edd86\" data-id=\"84edd86\" 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-00289f9 elementor-widget elementor-widget-image\" data-id=\"00289f9\" data-element_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<img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor\/assets\/images\/placeholder.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\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\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>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Navigating the Final Countdown: Key Deadlines and Compliance Requirements for IVDR Transition Understanding the EU IVDR Compliance Deadlines The EU In Vitro Diagnostic Regulation (IVDR) (EU 2017\/746), which went into effect on May 26, \u00a02022, replaces the In Vitro Diagnostic Directive 98\/79\/EC (IVDD). It introduces stricter requirements, including new risk classifications, increased clinical evidence requirements, [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":8282,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[34],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/key-deadlines-and-compliance-requirements-for-ivdr-transition\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Navigating the Final Countdown: Key Deadlines and Compliance Requirements for IVDR Transition Understanding the EU IVDR Compliance Deadlines The EU In Vitro Diagnostic Regulation (IVDR) (EU 2017\/746), which went into effect on May 26, \u00a02022, replaces the In Vitro Diagnostic Directive 98\/79\/EC (IVDD). 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