{"id":6909,"date":"2023-07-28T23:30:46","date_gmt":"2023-07-28T23:30:46","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=6909"},"modified":"2024-01-12T21:01:15","modified_gmt":"2024-01-12T21:01:15","slug":"eu-ivdr-changes-2017-746","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-changes-2017-746\/","title":{"rendered":"The EU IVDR: An Overview of Regulatory Requirements in 2017\/746"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6909\" class=\"elementor elementor-6909\" 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-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" 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-6dd05cd3\" data-id=\"6dd05cd3\" 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-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" 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-6ea4084d\" data-id=\"6ea4084d\" 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-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" 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\/2023\/07\/28\/\">\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\tJuly 28, 2023\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-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" 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\">The EU IVDR: An Overview of Regulatory Requirements in 2017\/746<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" 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\/2019\/02\/blood-sample-tubes-IVD-tests.jpeg\" class=\"attachment-full size-full wp-image-1454\" alt=\"In Vit\" 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-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" 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>Since the introduction of the\u00a0<em>In Vitro<\/em>\u00a0Diagnostic Directive (IVDD 98\/79\/EC) 20+ years ago, the majority of IVD manufacturers selling in Europe have had it pretty easy when it comes to EU compliance. That\u2019s because under IVDD 98\/79\/EC, about 80-90% of finished devices are not subject to Notified Body oversight. However, the era of <em>laissez faire<\/em>\u00a0is coming to an abrupt end.<\/p><p>European regulators have long recognized the shortcomings of the existing IVDD in protecting patients and spent years crafting an updated and greatly expanded set of regulations known as the\u00a0<em>In Vitro<\/em>\u00a0Diagnostic Regulation (2017\/746), or simply the IVDR. To underscore the importance of stricter oversight, the requirements governing IVDs have been elevated to a regulation from a directive, which means every EU member country must apply the same regulation in their national law, with the same implementation date.<\/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-6006e54b elementor-widget elementor-widget-heading\" data-id=\"6006e54b\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Get Ready! The IVDR Is Far More Comprehensive Than the IVDD It Will Replace<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ce6da04 elementor-widget elementor-widget-text-editor\" data-id=\"2ce6da04\" 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>The IVDR is not simply a fresh coat of paint for the IVDD. EU regulators have torn down the existing building and reconstructed it using new blueprints. The IVDR greatly increases the number of IVD devices subject to rigorous oversight and expands the scope of compliance. It is based on the GHTF classification system and brings European regulations into closer harmonization with global classification for\u00a0<em>in vitro<\/em>\u00a0diagnostic devices that has been around for many years. To get a sense of the magnitude of the changes, simply look at the table below. The IVDR is roughly 4x longer than the IVDD it will replace!<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-3524 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Compare-IVDD-IVDR-length-e1601655436730.png\" alt=\"\" width=\"675\" height=\"111\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Compare-IVDD-IVDR-length-e1601655436730.png 675w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/Compare-IVDD-IVDR-length-e1601655436730-300x49.png 300w\" sizes=\"(max-width: 675px) 100vw, 675px\" \/><\/p><p>Throughout this article series we will reference numerous IVDR Annexes and Chapters. Navigating the IVDR can be quite a challenge. The crafters of the IVDR \u2013 having already succeeded at giving heart palpitations to thousands of IVD RA\/QA professionals \u2013 inflicted a final wound by leaving out a Table of Contents to navigate their 157-page tome. Fortunately, we have saved you from endless frustration and created a Table of Contents for you! You can download a fully linked\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-table-of-contents-2017-746\/\">IVDR Table of Contents<\/a>, which includes the original IVDR text.<\/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-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The Most Important Changes in the EU IVD Regulation That Will Impact Manufacturers<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" 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>It is obviously impossible to cover every change and requirement found in the IVDR, but here\u2019s a high-level summary of the most important updates. We\u2019ll talk about these in more detail later.<\/p><ul><li>The IVDR will require Notified Body intervention and review for 80-90% of IVDs sold in Europe, compared to 10-20% that were reviewed under the IVDD.<\/li><li>There are no grandfathering provisions. The date of application for moderate and high-risk IVDs to be certified and meet the IVDR was May 2022. Low risk IVDs have until May 2024 but must still meet IVDR QMS requirements. The EU Parliament and European Council adopted an amendment to provide longer IVDR transitions period for most, but not all, IVDs.\u00a0 See below the new IVDR transition timelines by device classification.<\/li><li>IVDR uses a risk-based rules classification scheme: Classes A, B, C, and D.\u00a0 (Chapter V &amp; Annex VIII).<\/li><li>Software as part of IVD instruments, SaMD (Software as a Medical Device), and apps are now included in the definition of IVDs and are regulated.<\/li><li>There is new oversight of single-use IVDs, companion diagnostics (CDx), and genetic tests.<\/li><li>There are more requirements for clinical evidence and performance studies (Chapter VI &amp; Annexes II, XIII, XIV).<\/li><li>The vigilance and postmarket surveillance requirements are far more stringent (Chapter VII &amp; Annex III).<\/li><li>Focus on labeling identification and UDI product traceability (2023 for Class D; 2025 for Classes C and B; 2027 for Class A). See Articles 24-27.<\/li><li>Manufacturers must appoint an EU-based Authorized Representative (if physically located outside the EU), an Importer and a Person Responsible for Regulatory Compliance (PRRC).<\/li><li>Class B, C, and D manufacturers will be required to have a quality management system and technical documentation review\u00a0<u>and<\/u>be subject to unannounced Notified Body audits (Annexes II, III, IX, X, XI).<\/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-0f0f011 elementor-widget elementor-widget-heading\" data-id=\"0f0f011\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The IVDR Expands the Definition of an IVD in Europe<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-08bb4a2 elementor-widget elementor-widget-text-editor\" data-id=\"08bb4a2\" 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>Not long ago, the definition of an IVD in Europe was pretty clear-cut. Today, not so much. As new diagnostic technologies have developed, the traditional concept of\u00a0<em>in vitro<\/em>\u00a0diagnostics has expanded. Health data that was previously delivered only through clinicians is now available directly to patients on their smartphones or via email. Advances in genetic testing have made predictive health data available to the masses. That same technology can be used to help customize treatment plans for patients. Such advances offer obvious benefits for patient care, but they also bring the risks associated with false-positives and misinterpretation of data. Given these ongoing advances, the IVDR expands the previous definition of an\u00a0<em>in vitro<\/em>\u00a0diagnostic medical device, as seen in the highlighted text below.<\/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-10b2a81 elementor-widget elementor-widget-image\" data-id=\"10b2a81\" 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\" width=\"793\" height=\"448\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/IVDR-article-2-e1592855951992.png\" class=\"attachment-full size-full wp-image-2865\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/IVDR-article-2-e1592855951992.png 793w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/IVDR-article-2-e1592855951992-300x169.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/05\/IVDR-article-2-e1592855951992-768x434.png 768w\" sizes=\"(max-width: 793px) 100vw, 793px\" \/>\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-17b2a83c elementor-widget elementor-widget-heading\" data-id=\"17b2a83c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The New EU IVDR Classification Scheme: As Simple as A, B, C, \u2026 and D<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-3fded163 elementor-widget elementor-widget-text-editor\" data-id=\"3fded163\" 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>The current IVD directive uses a list-based classification scheme that is very limited in application. In fact, that list in Annex II of the IVDD only takes up half a page, with a short list of what is reviewed by Notified Bodies. The IVDR throws those lists out the regulatory window and applies a new risk-based classification system that\u2019s based heavily on a\u00a0<a href=\"http:\/\/www.imdrf.org\/docs\/ghtf\/final\/sg1\/procedural-docs\/ghtf-sg1-n045-2008-principles-ivd-medical-devices-classification-080219.pdf\">GHTF IVD classification guidance<\/a>\u00a0published in 2008.<\/p><p>Article 47 of the IVDR briefly discusses classification, but Annex VIII contains the seven rules you will use to classify your device. The new IVDR separates devices into four classes: A, B, C, and D. Class A is for low-risk products and Class D, as you smartly surmise, is reserved for high-risk products.<\/p><p>Under the new scheme, the vast majority of\u00a0<em>in vitro<\/em>\u00a0diagnostics that will require Notified Body intervention will fall under Classes B and C. Class D IVDs are quite limited in number, as is the case with Class III devices under the MDR. However, it should be noted that sterile IVDs in Class A will also require Notified Body assessment, although only pertaining to the sterilization aspects. The classification rules also bring companion diagnostics (CDx), genetic testing, and stand-alone software into the gravitational orbit of the IVDR. If the device has multiple intended uses \u2013 and those uses place the device into different classes \u2013 the highest applicable classification applies.<\/p><p>\u00a0<\/p><table width=\"697\"><tbody><tr><td colspan=\"2\" width=\"697\"><p>Structure of the\u00a0<em>In Vitro<\/em>\u00a0Diagnostic Regulation (2017\/746)<\/p><p><strong><em>Download the complete IVDR plus a linked\u00a0<\/em><\/strong><a href=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-table-of-contents-2017-746\/\"><strong><em>Table of Contents<\/em><\/strong><\/a><strong><em>.<\/em><\/strong><\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter I<\/strong><\/p><\/td><td width=\"592\"><p>Introductory provisions<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter II<\/strong><\/p><\/td><td width=\"592\"><p>Making available on the market, and putting into service of devices, obligations of economic operators, CE Marking, free movement<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter III<\/strong><\/p><\/td><td width=\"592\"><p>Identification and traceability of devices, registration of devices and economic operators, summary of safety and clinical performance, European database on medical devices<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter IV<\/strong><\/p><\/td><td width=\"592\"><p>Notified bodies<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter V<\/strong><\/p><\/td><td width=\"592\"><p>Classification and conformity assessment<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter VI<\/strong><\/p><\/td><td width=\"592\"><p>Clinical evidence, performance evaluation and performance studies<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter VII<\/strong><\/p><\/td><td width=\"592\"><p>Postmarket surveillance, vigilance and market surveillance<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter VIII<\/strong><\/p><\/td><td width=\"592\"><p>Cooperation between member states, medical device coordination group, EU reference laboratories and device registers<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter IX<\/strong><\/p><\/td><td width=\"592\"><p>Confidentiality, data protection, funding and penalties<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Chapter X<\/strong><\/p><\/td><td width=\"592\"><p>Final provisions<\/p><\/td><\/tr><tr><td width=\"104\">\u00a0<\/td><td width=\"592\">\u00a0<\/td><\/tr><tr><td width=\"104\"><p><strong>Annex I<\/strong><\/p><\/td><td width=\"592\"><p>General safety and performance requirements<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex II<\/strong><\/p><\/td><td width=\"592\"><p>Technical documentation<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex III<\/strong><\/p><\/td><td width=\"592\"><p>Technical documentation on postmarket surveillance<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex IV<\/strong><\/p><\/td><td width=\"592\"><p>EC declaration of conformity<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex V<\/strong><\/p><\/td><td width=\"592\"><p>CE Marking of conformity<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex VI<\/strong><\/p><\/td><td width=\"592\"><p>Information to be submitted upon the registration of devices and economic operators in accordance with articles 26(3) and 28, core data elements to be included in the UDI database together with UDI-DI in accordance with articles 25 and 26 of the UDI system.<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex VII<\/strong><\/p><\/td><td width=\"592\"><p>Requirements to be met by Notified Bodies<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex VIII<\/strong><\/p><\/td><td width=\"592\"><p>Classification rules<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex IX<\/strong><\/p><\/td><td width=\"592\"><p>Conformity assessment, based on a quality management system and on assessment of technical documentation<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex X<\/strong><\/p><\/td><td width=\"592\"><p>Conformity assessment based on type examination<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex XI<\/strong><\/p><\/td><td width=\"592\"><p>Conformity assessment based on production quality assurance<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex XII<\/strong><\/p><\/td><td width=\"592\"><p>Certificates issued by a notified body<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex XIII<\/strong><\/p><\/td><td width=\"592\"><p>Performance evaluation, performance studies and postmarket performance follow-up<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex XIV<\/strong><\/p><\/td><td width=\"592\"><p>Interventional clinical studies and certain other performance studies<\/p><\/td><\/tr><tr><td width=\"104\"><p><strong>Annex XV<\/strong><\/p><\/td><td width=\"592\"><p>Correlation table (with the IVDD)<\/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-b22d9ec elementor-widget elementor-widget-heading\" data-id=\"b22d9ec\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The New EU IVDR Classification Scheme: As Simple as A, B, C, \u2026 and D<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c2c6c9a elementor-widget elementor-widget-text-editor\" data-id=\"c2c6c9a\" 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>The timelines for transition from the\u00a0<em>In Vitro<\/em>\u00a0Diagnostic Directive (98\/79\/EC) to the\u00a0<em>In Vitro<\/em>\u00a0Diagnostic Regulation (IVDR 2017\/746) are outlined in Article 110 of the IVDR. However, the EU Parliament and European Commision adopted an amendment to provide longer IVDR transitions period for most, but not all, IVDs.\u00a0 See below the new IVDR transition timelines by device classification.<\/p><p>Class A non-sterile IVD &#8211; Must comply with IVDR immediately<\/p><p>Class A sterile IVD &#8211; Must comply with IVDR by <strong>May 26, 2027<\/strong><\/p><p>Class B IVD &#8211; Must comply with IVDR by <strong>May 26, 2027<\/strong><\/p><p>Class C IVD &#8211; Must comply with IVDR by <strong>May 26, 2026<\/strong><\/p><p>Class D IVD &#8211; Must comply with IVDR by <strong>May 26, 2025<\/strong><\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-3528 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-timeline-e1601655597865.png\" alt=\"\" width=\"675\" height=\"281\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-timeline-e1601655597865.png 675w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-timeline-e1601655597865-300x125.png 300w\" sizes=\"(max-width: 675px) 100vw, 675px\" \/><\/p><p>Here are some typical examples of devices and when they might\/must make the transition from IVDD to IVDR<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-3527 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-scenarios-1-e1606681676685.png\" alt=\"\" width=\"675\" height=\"360\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-scenarios-1-e1606681676685.png 675w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-scenarios-1-e1606681676685-300x160.png 300w\" sizes=\"(max-width: 675px) 100vw, 675px\" \/><\/p><p><em>*Because the renewal date for this IVDD certificate falls so close to the IVDR implementation date, it may be difficult to get Notified Body resources for renewal. Plan far ahead.<\/em><\/p><p><em>**Even though the certificate is normally valid for 5 years, the IVDR mandates that all IVDD certificates expire no later than May 27, 2024.<\/em><\/p><p>\u00a0<\/p><p>Depending on your IVDR classification, the last day any device can be sold or put into service under the IVDD is as early as May 26, 2022 but no later than May 26, 2027.<\/p><p>Of course, the table above focuses on how you can maximize the leniency associated with the existing\u00a0<em>In Vitro<\/em>\u00a0Diagnostic Directive (98\/79\/EC). In some cases, you may choose not to renew your existing IVDD certificate and pursue IVDR certification instead. That may seem crazy, but there are situations where this may make sense. If your product has strong clinical data, certify early to gain a competitive advantage. If it has a marginal story to tell, perhaps wait to allow more time to gather the necessary data. Smart companies will be rewarded with lower costs if they take this seriously and do not procrastinate on their compliance efforts.<\/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-63144a0 elementor-widget elementor-widget-heading\" data-id=\"63144a0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">IVDR Technical Documentation Needed to Support CE Marking Certification in Europe<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f552ced elementor-widget elementor-widget-text-editor\" data-id=\"f552ced\" 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>As mentioned,\u00a0IVD\u00a0classification is changing; as a result, many more devices will require review by Notified Bodies. This means European Notified Bodies (NB) will review your compilation of technical information, classification rationale, and \u2013 more important \u2013 your documentation supporting performance evaluation. A significant number of IVD companies that sell in the United States may find it easier to achieve compliance with the EU IVDR than companies that do not sell those same IVDs in the US. Why? Companies selling diagnostic products that are 510(k) cleared in the US will already have obtained from clinical sources much of the supporting testing and performance data that is necessary to comply with many (but certainly not all) of the new IVDR requirements. Of course, there are many IVD products that are 510(k)-exempt and not subject to FDA scrutiny (e.g., common blood tests), so companies need to carefully examine the new EU IVDR classification rules in Annex VIII to see where the chips fall.<\/p><p>Let\u2019s take a look at the technical documentation requirements. We will talk more about specific postmarket data requirements later.<\/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-cb1f1b4 elementor-widget elementor-widget-heading\" data-id=\"cb1f1b4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Technical Documentation Mandated Under the EU IVDR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5b075c5 elementor-widget elementor-widget-text-editor\" data-id=\"5b075c5\" 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>Most manufacturers of Class B, C, and D devices will generally need to provide the following information for Notified Body review in order to obtain CE Marking. Manufacturers of Class A devices also need to compile this information, but it will not be reviewed by a Notified Body prior to those devices being placed on the EU market.<\/p><p>Technical documentation includes:<\/p><ul><li>Device specification, including intended purpose\/use, principles of method\/operation, etc.<\/li><li>Overview of previous and similar generations of the device<\/li><li>Design and manufacturing information<\/li><li>General safety and performance requirements<\/li><li>Risk benefit analysis<\/li><li>Product verification and validation<\/li><\/ul><p>Clinical performance can be demonstrated through:<\/p><ul><li>Clinical performance studies<\/li><li>Peer-reviewed published literature<\/li><li>Experience gained through routine testing<\/li><\/ul><p>Clinical testing to generate performance data will be required for Class B, C, and D\u00a0<em>in vitro<\/em>\u00a0diagnostic devices (and Class A as applicable) and the requirements are more complex than they are for most medical devices. As the manufacturer, you must demonstrate that your test is necessary to make a medical decision related to indications for use established for the device. For manufacturers of established and standardized tests, putting together this information will be easier if clinical guidelines are already in place, similar tests exist in the marketplace, and comparable results exist regardless of manufacturer.<\/p><p>\u00a0<\/p><p><strong><em>Save time and frustration!<\/em><\/strong>\u00a0<a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU_IVDR-2017-746-Regulation%2BTable-of-Contents.pdf\"><strong>Download a fully linked IVDR Table of Contents<\/strong><\/a><strong>\u00a0<\/strong>that includes the original IVDR text.<\/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-e036bcc elementor-widget elementor-widget-heading\" data-id=\"e036bcc\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The IVD PER (Performance Evaluation Report)<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f80a1b5 elementor-widget elementor-widget-text-editor\" data-id=\"f80a1b5\" 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>The PER is new to the IVDR but is similar to the EU Clinical Evaluation Report (CER), which is common in the medical device world. The PER is not a single report; rather, it is a collection of data that forms a key element of your overall technical documentation. Chapter VI, Article 56 and Annex VIII, Part A (1.3.2) of the IVDR outline the specific components of the PER and specify that it must include the following:<\/p><ul><li>Scientific validity report<\/li><li>Analytical performance report<\/li><li>Clinical performance report<\/li><\/ul><p>It is important to keep in mind that the Performance Evaluation Report is not a \u201conce and done\u201d exercise! The IVDR makes it very clear that you are expected to update your PER throughout the entire life cycle of the device with data from your Postmarket Performance Follow-Up (PMPF) plan. Performance reports for Class C and D devices must be done as needed\u00a0<strong><em><u>but at least annually<\/u><\/em><\/strong>. PERs for Class A and B devices can be updated as needed, although if you make Class B devices and have not updated your PER in three years, you better have a good explanation as to why it may not be current when your Notified Body comes knocking during your surveillance audit.<\/p><p>The PER has all of the analytics like sensitivity, specificity, ROC curves, reproducibility, stability, etc. These have been required as part of the FDA 510(k) process for a long time, so those companies that have secured US clearance\/approval will find the PER reasonably easy to compile.\u00a0However, like the CER required for medical devices sold in Europe, the PER must support the clinical benefit and clinical utility of the IVD test.\u00a0This means that a manufacturer may have a test with an intended use to find biomarkers Beta42, tau-131, and tau-233 that claims if all three are present then there is an 85% chance of developing Alzheimer\u2019s.\u00a0Your PER must have the clinical data to support a claim like this.<\/p><p>In addition to the requirements noted above, Annex IX, Section 5.1 also requires manufacturers of Class B, C, and D self-testing and near-patient testing devices to submit their product (unless impractical) for a design evaluation by the Notified Body. After this physical assessment of your product, your Notified Body may ask you to carry out more tests. Section 5.2 stipulates specific requirements for companion diagnostics (CDx), so be sure to read this section in Annex IX if that applies to you.<\/p><p>The European Commission published <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-01\/mdcg_2022-2_en.pdf\">MDCG 2022-2<\/a> \u00a0on guidance for compiling a Performance Evaluation Plan and a Performance Evaluation Report. All of this documentation must be made permanently available to your European Authorized Representative (EC REP). Additional European Commission MDCG endorsed documents and guidances in applying IVD regulations can be found at <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec12\">MDCG endorsed documents and other guidance<\/a>.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-f0a77e4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f0a77e4\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-100 elementor-inner-column elementor-element elementor-element-9761fc0\" data-id=\"9761fc0\" 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-b4aba7e elementor-widget elementor-widget-text-editor\" data-id=\"b4aba7e\" 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><em>Article 15 of the IVDR introduces the new role of the P<\/em><strong><em>erson Responsible for Regulatory Compliance (PRRC)<\/em><\/strong><em>. Make sure you read this IVDR Article (and\u00a0<\/em><a href=\"https:\/\/www.orielstat.com\/blog\/eu-prrc-person-responsible-regulatory-compliance\/\"><em>this article<\/em><\/a><em>) carefully. This appointee (perhaps you!) will have tremendous responsibility and must meet certain educational and\/or professional experience requirements. Note that the PRRC has different responsibilities than your Authorized Representative (EC REP).<\/em><\/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<div class=\"elementor-element elementor-element-a70a93c elementor-widget elementor-widget-heading\" data-id=\"a70a93c\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Expect Serious Notified Body Scrutiny of Your Clinical Data<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8e10e77 elementor-widget elementor-widget-text-editor\" data-id=\"8e10e77\" 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>Annex X, Section 3c sets the tone for how seriously regulators will be looking at your clinical data as part of performance evaluation<em>.\u00a0<\/em>It states: \u201cThe notified body shall employ device reviewers with sufficient clinical expertise and, if necessary, use external clinical experts with direct and current experience relating to the clinical application of the device in question for the purposes of that review.\u201d<\/p><p>That does not mean that Notified Bodies will be reviewing technical documentation for every device in your arsenal. For Class B devices, one set of technical documentation will be evaluated per\u00a0<em>device category<\/em>. For Class C devices, one per\u00a0<em>generic device group<\/em>. You should expect a different device to be evaluated each year. Notified Bodies will use random sampling as a proxy for your overall state of compliance. Because the Notified Body gets to choose, you better make sure all of your devices are compliant. Class D, companion diagnostics (CDx), self-testing devices, and point-of-care devices are the exceptions to the sampling rule \u2013 all technical documentation for such devices will be evaluated.<\/p><p>Your technical documentation must be kept on file for at least 10 years from the date the last product was placed on the European market. Chapter III of Annex IX outlines the specifics.<\/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-cfac6c1 elementor-widget elementor-widget-heading\" data-id=\"cfac6c1\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">The Impact for IVD Companies<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2f6e5ef elementor-widget elementor-widget-text-editor\" data-id=\"2f6e5ef\" 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>The IVDR will affect companies in vastly different ways. Some will be in good shape and have most or all of the necessary clinical data. Some, however, will be unpleasantly surprised. If your company makes an IVD that:<\/p><ul><li>Is not on List A or B and does not require Notified Body intervention under the IVDD, but\u2026<\/li><li>Will qualify as a Class B, C, or D device under Annex VIII of the IVDR, but\u2026<\/li><li>You have limited performance and clinical data for the device, and\/or\u2026<\/li><li>That device does\u00a0<em>not<\/em>have US FDA 510(k) clearance\u2026<\/li><li>Is not manufactured under an ISO 13485 Quality Management System\u2026<\/li><\/ul><p>\u2026 then buckle up \u2013 you are in for a wild ride over the next few years. The regulatory landscape is set to change dramatically in Europe and the carefree days of minimal EU regulatory oversight (for most) are nearly over. Sometime in the (near) future you may find yourself around a conference room table with other managers discussing whether the new IVDR paradigm is worth the effort for specific products in your portfolio. Go into that meeting with eyes wide open.<\/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-cb232f4 elementor-widget elementor-widget-heading\" data-id=\"cb232f4\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">IVDR Conformity Assessment, Postmarket Surveillance, and Vigilance Requirements<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-193c6c5 elementor-widget elementor-widget-text-editor\" data-id=\"193c6c5\" 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>The European IVDR mandates that all manufacturers \u2013 even those who manufacture Class A products \u2013 have an operating QMS.\u00a0While manufacturers of all Class A products need a modest QMS and may \u201cself-declare\u201d conformity with CE Marking, there is no free pass for manufacturers of Class B, C, and D products. Most companies currently in compliance with the FDA Quality System Regulation (21 CFR Part 820) will need to upgrade their systems to comply with ISO 13485:2016 if they have not already done so. Even though ISO 13485 is technically a voluntary standard for QMS compliance, in reality it is the\u00a0<em>de facto<\/em>\u00a0standard for QMS compliance.<\/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-a528ee0 elementor-widget elementor-widget-heading\" data-id=\"a528ee0\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conformity Assessment Options for Manufacturers Under the IVDR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e81dd49 elementor-widget elementor-widget-text-editor\" data-id=\"e81dd49\" 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>Manufacturers of Class C and D devices have options for conformity assessment in the IVDR as follows:<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-3532 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-classification-e1601667323429.png\" alt=\"\" width=\"675\" height=\"452\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-classification-e1601667323429.png 675w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/IVDR-classification-e1601667323429-300x200.png 300w\" sizes=\"(max-width: 675px) 100vw, 675px\" \/><\/p><p>Article 46 mandates that all Notified Bodies must post their standard fees for performing conformity assessments, so it should be easy for you to compare prices as you prepare your compliance plan and budgets.<\/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-7f943eb elementor-widget elementor-widget-heading\" data-id=\"7f943eb\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Vigilance and PMS Requirements in the IVDR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-787c376 elementor-widget elementor-widget-text-editor\" data-id=\"787c376\" 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>Chapter VII of the IVDR outlines which type of data, sources, and analysis methods manufacturers should collect as part of ongoing efforts related to postmarket activities. The purpose is to gather postmarket data as part of a manufacturer\u2019s continuing review of risk versus clinical benefit associated with their products. The chapter is actually quite similar to what is required for medical devices under the MDR (EU 2017\/745). This includes the need for manufacturers to:<\/p><ul><li>Establish a postmarket surveillance (PMS) system. (Article 78)<\/li><li>Establish a PMS plan to guide the system. (Article 79)<\/li><li>Prepare a Postmarket Surveillance Report (PMSR) outlining conclusions of data gathered from your PMS plan plus any corrective action. Updated as needed. (Article 80, Classes A and B only)<\/li><li>Prepare a Periodic Safety Update Report (PSUR) that has the same information as a PMSR but also includes a risk analysis, sales volumes, user population characteristics, and use frequency. Update at least annually for Class D and every two years for Class C. (Article 81, Classes C and D only)<\/li><li>Report serious incidents and Field Safety Corrective Actions (FSCA). (Article 82)<\/li><li>Prepare trend reports on incidents. (Article 83)<\/li><li>Analyze serious incidents and FSCAs and report them. (Article 84)<\/li><\/ul><p>Annex III provides some additional detail on the technical documentation needed related to postmarket surveillance. Notable among the requirements is that you must maintain a \u201cproactive and systematic process\u201d of collecting information. Annex III also mandates that you prepare a Postmarket Performance Follow-Up Plan (PMPF) or provide a reason why it should not apply to your device.<\/p><p>An important thing to understand about postmarket surveillance under the IVDR is that your PMS process must be continuous and proactive (not static and reactive) and has a direct link to your risk management file. Gone are the days when you could market your IVD in Europe and assume all was well because no incidents were reported last year. Your Notified Body will be examining your efforts to proactively monitor the safety of your products on the EU market. Postmarket surveillance covers a wide variety of sources managed through a quality management system, so make sure this is integrated into your current processes or create new processes as required.<\/p><p>\u00a0<\/p><p><strong><em>Save time and frustration!<\/em><\/strong>\u00a0<a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU_IVDR-2017-746-Regulation%2BTable-of-Contents.pdf\"><strong>Download a fully linked IVDR Table of Contents<\/strong><\/a><strong>\u00a0<\/strong>that includes the original IVDR text.<\/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-e4c94c3 elementor-widget elementor-widget-heading\" data-id=\"e4c94c3\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Incident Reporting Under the IVDR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0318b8a elementor-widget elementor-widget-text-editor\" data-id=\"0318b8a\" 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>Article 82 details requirements for reporting incidents. As with medical devices, the IVDR mandates that your reporting take into account the severity of the incident. You are required to report an incident no later than 15 calendar days after you become aware of it. Incidents that might pose serious public health threats must be reported within 2 calendar days. Thus, if you learn about something on Friday you better report it by Sunday, even if it\u2019s a preliminary report that will be appended later \u2013 no exceptions. If the incident caused a death or \u201cserious deterioration in a person\u2019s state of health,\u201d the reporting timeframe is 10 days. There are many additional requirements in Article 82, so you\u2019ll want to study this carefully.<\/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-e91cf7f elementor-widget elementor-widget-heading\" data-id=\"e91cf7f\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">EUDAMED: The New Centralized Database for Medical Devices and IVDs<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6a05eed elementor-widget elementor-widget-text-editor\" data-id=\"6a05eed\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">Many companies have been performing PMS activities all along, especially if they\u2019re marketing in other countries. However, this may seem like a bureaucratic overreach for companies that have not been required to do so and whose products have excellent safety records. Alas, there is a logical reason for it. Following the implementation of the Medical Device Regulation (EU 2017\/745) will come the rollout of the long-planned EUDAMED database. EUDAMED will also be used for IVDs, giving European Competent Authorities in all EU countries a centralized reference to track serious incidents, field safety notices, corrective actions, and Periodic Safety Update Reports (<\/span><a href=\"https:\/\/www.orielstat.com\/blog\/psur-pmsr-requirements-in-eu-mdr\/\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666; text-decoration: none; text-underline: none;\">PSUR<\/span><\/a><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">) \u2013 all in the name of greater transparency and patient safety.<\/span><\/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-f3c6dea elementor-widget elementor-widget-heading\" data-id=\"f3c6dea\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What You Should Be Doing Now to Prepare for the IVDR<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e02cd84 elementor-widget elementor-widget-text-editor\" data-id=\"e02cd84\" 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><span style=\"font-size: 11pt; font-family: Mulish;\">If you have not already started preparing for your transition to the European In Vitro Diagnostic Regulation, here are some recommendations on where to start.<\/span><\/strong><\/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-213748d elementor-widget elementor-widget-heading\" data-id=\"213748d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">1 \u2013 Conduct an Internal IVDR Gap Assessment ASAP<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-05df4d4 elementor-widget elementor-widget-text-editor\" data-id=\"05df4d4\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">Conduct a robust assessment to see where you stand with regard to future compliance in Europe. A gap assessment is the first step and should answer these questions, among others: What classification will your IVDs have under the IVDR? What performance and clinical data do you already have to support registration, and is it robust enough? Do you have a quality management system in place? Are you prepared to get certified to ISO 13485:2016 if needed? An important first step is for you and your team to review the existing Essential Requirements found in the IVDD and compare those to the new General Safety and Performance Requirements (GSPR) found in the IVDR.<\/span><\/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-f6070ce elementor-widget elementor-widget-heading\" data-id=\"f6070ce\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">2 \u2013 Make Your IVDD to IVDR Transition Plan a Priority<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ba7b27 elementor-widget elementor-widget-text-editor\" data-id=\"2ba7b27\" 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>If you manufacture a range of IVD products, it is vital that you come up with a transition plan for those products that takes the following into account:<\/p><ul><li>The availability of Notified Body resources for your specific IVD categories (see below)<\/li><li>The expiration timing of any existing CE certificates issued under the IVDD (if applicable)<\/li><li>The need for obtaining CE certification prior to the compliance date for those many newly classified products<\/li><li>The internal staffing or consultant availability to handle increased workload.<\/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-00828a5 elementor-widget elementor-widget-heading\" data-id=\"00828a5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">3 \u2013 Get in Line Now: The IVDR Is Going to Overwhelm Notified Bodies and Reference Labs<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-84d80e8 elementor-widget elementor-widget-text-editor\" data-id=\"84d80e8\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">The IVDR will apply to 85-90% of IVDs sold in Europe, up from 10-15% now. You don\u2019t have to be a math genius to figure out that demands for Notified Body services will rise exponentially. It is already very difficult to get Notified Body services for audits and product technical reviews. Each Notified Body must be designated to be allowed to certify IVDs and not all Notified Bodies are designated to handle all IVD categories. Likewise, reference labs are going to be swamped with testing of higher-classified products. You should start discussions with Notified Bodies and these labs right away to make sure they will be able to handle your specific products and ensure your place in line.<\/span><\/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-b526f0d elementor-widget elementor-widget-heading\" data-id=\"b526f0d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">4 - Your Importers, Distributors, and Authorized Representative Will Have More Responsibilities Make Sure They Are Also Getting Ready<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-424b442 elementor-widget elementor-widget-text-editor\" data-id=\"424b442\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">The IVDR will require input from a range of players involved in the manufacturing, importation, and sale of your products. These entities, who now fall under designation of Economic Operators (as defined in Article 2), will take on new responsibilities. As the manufacturer, it is your job to make sure that your EU Authorized Representative, importers, and distributors are all ready to assume their new obligations, which include adding information to the EUDAMED database. Set up meetings with your key distributors and importers and ask them about their plans to prepare for IVDR transition.<\/span><\/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-db20919 elementor-widget elementor-widget-heading\" data-id=\"db20919\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">5 \u2013 Get Everyone on Your Team Trained and on the Same Page Early<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a5c181a elementor-widget elementor-widget-text-editor\" data-id=\"a5c181a\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">Even for experienced IVD regulatory professionals, theres a lot of information to digest in the IVDR. Its quite easy to miss something given the complexity of the regulation and its many cross-references. Part of your early planning process should include staff training. This could take the form of regularly scheduled internal meetings to discuss various aspects of the regulation or \u00a0<\/span><a href=\"https:\/\/www.orielstat.com\/courses\/eu-ivdr-training-2017-746\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #0072c2;\">training on the IVDR<\/span><\/a><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">. Either way, start early so everyone understands the requirements and the plan for meeting them. If you have numerous products in your portfolio, starting early becomes even more critical.<\/span><\/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-f4bb588 elementor-widget elementor-widget-heading\" data-id=\"f4bb588\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">6 - Discuss Internally on a Product-by-Product Basis: Is It Worth the Effort?<\/h3>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6fb2ffe elementor-widget elementor-widget-text-editor\" data-id=\"6fb2ffe\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">Plenty of companies selling in Europe and other countries with minimal regulatory oversight of IVDs will take one look at the IVDR and ultimately decide to throw in the towel. There are perfectly rational reasons to call it quits. Some products might be nearing the end of their useful life or might have such low margins or revenue that the additional cost of compliance exceeds the profitability of the products sold in the European market. These are discussions to have early on after you have conducted a gap analysis.<\/span><\/p><p style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">There is a glass half-full aspect to all of this. The IVDR presents an opportunity for IVD companies that don\u2019t already sell in the US market. How? Companies that decide to make the extra effort to comply with the IVDR will find themselves in an excellent position to gain 510(k) clearance in the US should they choose to do so opening the door to another enormous market.<\/span><\/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-736f292 elementor-widget elementor-widget-heading\" data-id=\"736f292\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Job Security<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ba7c6f7 elementor-widget elementor-widget-text-editor\" data-id=\"ba7c6f7\" 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 style=\"line-height: 18.0pt; margin: 3.75pt 0in 3.75pt 0in;\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">If there\u2019s one good thing to come out of the IVDR, it\u2019s that a whole lot of people with IVD regulatory experience can expect absolute job security for years to come. (That means\u00a0<em><span style=\"font-family: Mulish;\">you<\/span><\/em>.) However, it also underscores the need to staff up earlier than you might otherwise plan to do. Don\u2019t wait until mass panic ensues and you are competing with everyone else for talent. The issues of resources should not be ignored. You are not a superhero (yet) and your existing workload won\u2019t disappear during IVDR transition time. Plan out the migration of products to the IVDR and try to estimate how much work will be required. Figure out what your existing team will realistically be able to handle, how much staff you will need to add, and what you want to outsource. If you plan to work with outside consultants, establish a relationship early on to help you plan because they, too, will have more work than they can handle as the deadline gets closer. Surprise,\u00a0<\/span><a href=\"https:\/\/www.orielstat.com\/practice\/medical-device-RA-QA\"><span style=\"font-size: 10.5pt; font-family: Mulish; color: #0072c2;\">we can help<\/span><\/a><span style=\"font-size: 10.5pt; font-family: Mulish; color: #666666;\">\u00a0with that.<\/span><\/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-04e33f5 elementor-widget elementor-widget-heading\" data-id=\"04e33f5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to Learn More about the IVDR?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2a155bb elementor-widget elementor-widget-text-editor\" data-id=\"2a155bb\" 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>If you really want to take a deep dive into the IVDR, consider our in-depth\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-ivdr-training-2017-746\">training class on the IVDR<\/a>. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/capa-for-medical-devicecompliance\/\">CAPA and Root Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\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<\/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>The EU IVDR: An Overview of Regulatory Requirements in 2017\/746 Since the introduction of the\u00a0In Vitro\u00a0Diagnostic Directive (IVDD 98\/79\/EC) 20+ years ago, the majority of IVD manufacturers selling in Europe have had it pretty easy when it comes to EU compliance. That\u2019s because under IVDD 98\/79\/EC, about 80-90% of finished devices are not subject to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1454,"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>The EU IVDR: An Overview of Regulatory Requirements in 2017\/746<\/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\/eu-ivdr-changes-2017-746\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"The EU IVDR: An Overview of Regulatory Requirements in 2017\/746\" \/>\r\n<meta property=\"og:description\" content=\"The EU IVDR: An Overview of Regulatory Requirements in 2017\/746 Since the introduction of the\u00a0In Vitro\u00a0Diagnostic Directive (IVDD 98\/79\/EC) 20+ years ago, the majority of IVD manufacturers selling in Europe have had it pretty easy when it comes to EU compliance. That\u2019s because under IVDD 98\/79\/EC, about 80-90% of finished devices are not subject to [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-changes-2017-746\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2023-07-28T23:30:46+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T21:01:15+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/02\/blood-sample-tubes-IVD-tests.jpeg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"1\" \/>\r\n\t<meta property=\"og:image:height\" content=\"1\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"24 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"The EU IVDR: An Overview of Regulatory Requirements in 2017\/746","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-changes-2017-746\/","og_locale":"en_US","og_type":"article","og_title":"The EU IVDR: An Overview of Regulatory Requirements in 2017\/746","og_description":"The EU IVDR: An Overview of Regulatory Requirements in 2017\/746 Since the introduction of the\u00a0In Vitro\u00a0Diagnostic Directive (IVDD 98\/79\/EC) 20+ years ago, the majority of IVD manufacturers selling in Europe have had it pretty easy when it comes to EU compliance. 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