{"id":7216,"date":"2023-07-03T23:50:36","date_gmt":"2023-07-03T23:50:36","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7216"},"modified":"2024-01-11T16:11:13","modified_gmt":"2024-01-11T16:11:13","slug":"eu-ivdr-per-best-practices","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/","title":{"rendered":"Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7216\" class=\"elementor elementor-7216\" 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\/03\/\">\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 3, 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\">Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1198213 elementor-widget elementor-widget-image\" data-id=\"1198213\" 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\" width=\"300\" height=\"200\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/IVDR-blog-significantchange-300x200-1.jpg\" class=\"attachment-large size-large wp-image-5211\" 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<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>Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe\u2019s new In Vitro Diagnostic Regulation (IVDR 2017\/746) will impose strict new requirements on many IVD manufacturers seeking CE Marking for their devices.\u00a0 Going forward 85-90% of all IVDs seeking CE Marking certification in Europe will need to have their quality management system and technical documentation approved by a\u00a0European Notified Body designated to the IVDR. While Annex III of the In Vitro Diagnostic Directive (IVDD) always required performance evaluation data, the focus was only on analytical performance. Even then the need to produce this was not explicitly stated nor reviewed closely by Notified Bodies.<\/p><p><strong>What will be required by the IVDR going forward?<\/strong><\/p><p>Before we dig into that let\u2019s step back for a moment. Understanding your performance evaluation obligations starts with making sure you have the proper repository of documents at your disposal. Even if you have already downloaded a copy of the IVDR, get this\u00a0<a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU_IVDR-2017-746-Regulation%2BTable-of-Contents.pdf\">PDF version<\/a>\u00a0instead because it includes a linkable table of contents. You won\u2019t regret it. The relevant sections here are Chapter VI and Annex XIII.\u00a0 After that download these documents to your desktop:<\/p><ul><li><a href=\"https:\/\/www.imdrf.org\/documents\/ghtf-final-documents\/ghtf-study-group-5-clinical-safetyperformance\"><strong>GHTF SG5\/N6:2012<\/strong><\/a>\u2013 Clinical evidence for IVDs: Key definitions and concepts<\/li><li><a href=\"https:\/\/www.imdrf.org\/documents\/ghtf-final-documents\/ghtf-study-group-5-clinical-safetyperformance\"><strong>GHTF\u00a0SG5\/N7:2012<\/strong><\/a>\u2013 Clinical evidence for IVDs: Scientific Validity Determination and Performance Evaluation<\/li><li><a href=\"https:\/\/www.imdrf.org\/documents\/ghtf-final-documents\/ghtf-study-group-5-clinical-safetyperformance\"><strong>GHTF SG5\/N8:2012<\/strong><\/a>\u2013 Clinical evidence for IVDs \u2013 Clinical performance studies<\/li><li><a href=\"https:\/\/www.iso.org\/standard\/69455.html\"><strong>ISO 20916:2019<\/strong><\/a>\u2013 Clinical performance studies using specimens from human subjects<\/li><li><a href=\"https:\/\/ec.europa.eu\/health\/latest-updates\/mdcg-2022-2-guidance-general-principles-clinical-evidence-vitro-diagnostic-medical-devices-ivds-2022-01-27_en\"><strong>MDCG 2022-2<\/strong><\/a>\u2013 Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)<\/li><\/ul><p>And finally, because the classification of IVDs (A, B, C, D) is entirely new you\u2019ll also want a copy of the <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/update-mdcg-2020-16-rev2-guidance-classification-rules-vitro-diagnostic-medical-devices-under-2023-02-10_en\">MDCG 2020-16 rev 2 guidance document on IVD classification<\/a>.<\/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-c822fb5 elementor-widget elementor-widget-heading\" data-id=\"c822fb5\" 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\">It starts with a plan\u2026Performance Evaluation Process and Planning<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b959ace elementor-widget elementor-widget-text-editor\" data-id=\"b959ace\" 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>Performance evaluation<\/strong>\u00a0is important for many reasons, but the overarching goal is to prevent false positives or false negatives, both of which can have detrimental physical and psychological impacts on the patient.<\/p><p>It\u2019s tempting to jump in and tackle the nuts and bolts of doing a performance evaluation but it\u2019s really critical that you start by writing a\u00a0<strong>Standard Operating Procedure (SOP)<\/strong>\u00a0and creating a comprehensive\u00a0<strong>Performance Evaluation Plan (PEP)<\/strong>\u00a0as part of the planning requirements. Don\u2019t skip the SOP step as Article 56(3) of the IVDR mandates having a process established and implemented.<\/p><p>Even if you have US FDA 510(k) clearance for your device, the EU IVDR is very strict about demonstrating clinical benefits and you\u2019ll likely need to generate (and analyze) more data than you have now! In addition, European regulators have a completely different view of clinical benefits related to IVD medical devices as compared to US FDA.<\/p><p>There are certain elements that should be included in every\u00a0<strong>performance evaluation plan<\/strong>. They include, but are not limited to:<\/p><ul><li>The General Safety and Performance Requirements (GSPR) supported by your performance evaluation<\/li><li>Intended use or purpose of the device<\/li><li>Indications for use, limitations and contra-indications<\/li><li>Performance specifications of the IVD<\/li><li>A description of the current state of the art<\/li><li>Benefit-risk ratio parameters<\/li><li>Intended target patient groups<\/li><li>Analyte or marker to be used<\/li><li>Foundation for underlying software decision making (if applicable)<\/li><\/ul><p>It is important that you spend plenty of time preparing this plan because it will ultimately save you time when you actually complete the performance evaluation. Be mindful that your \u201cresearch\u201d may alter the product\u2019s risk assessment and risk management processes. You also want to consider whether you have the internal resources to conduct all aspects of the performance evaluation or whether you need to bring in outside expertise.<\/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-2a9f948 elementor-widget elementor-widget-heading\" data-id=\"2a9f948\" 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\">Steps in the IVD Performance Evaluation Process<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d0df07 elementor-widget elementor-widget-text-editor\" data-id=\"4d0df07\" 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><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-3662 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/PER-Inputs-e1608603973709.png\" alt=\"\" width=\"424\" height=\"259\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/PER-Inputs-e1608603973709.png 424w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/PER-Inputs-e1608603973709-300x183.png 300w\" sizes=\"(max-width: 424px) 100vw, 424px\" \/><\/p><p>\u00a0<\/p><h3>\u00a0<\/h3><h3>Proving SCIENTIFIC VALIDITY of your IVD<\/h3><p>If you\u2019re bringing a new product to market, it\u2019s important that you start this early in the lifecycle of your IVD. One way to do this is to use relevant information on the scientific validity of devices measuring the same analyte or marker. Obviously, you can and should perform a detailed literature search but if inadequate evidence is available you will need to do proof of concept, pre-clinical studies, or clinical performance studies. All of your findings will be summarized in your scientific validity report which will become part of your performance evaluation report. See IVDR Annex XIII, Part A for more information.<\/p><h3>\u00a0<\/h3><h3>Evaluating ANALYTICAL PERFORMANCE of your IVD<\/h3><p>IVDR Annex I, Section 9.1 describes the performance characteristics you must measure, depending on whether the test is qualitative or quantitative. These include sensitivity, specificity, repeatability, reproducibility, predictive value and more. You\u2019re required to maintain records of these performance characteristics for the life of the device. Plan your sampling carefully as the ability to create reproducible results is critical. The outcome of your analytical performance will be summarized in \u2013 you guessed it \u2013 an analytical performance report.<\/p><p>Annex II, 6.3 of the IDVR also dictates you need to examine claimed shelf life, shipping stability and in-use stability. And yes, you\u2019ll generate reports for that too. (You\u2019ll be very good at writing reports by the time your Notified Body audit rolls around.)<\/p><p>\u00a0<\/p><h3>Evaluating CLINICAL PERFORMANCE of your IVD<\/h3><p>You also need to conduct analysis of clinical performance, depending\u00a0 on the clinical condition you claim in association with the IVD. This can focus on its diagnostic accuracy, or its ability to monitor the progression of the pathology, or simply its association with a clinical claim. \u00a0\u00a0In most cases you\u2019ll need to conduct a clinical performance study which may utilize retrospective samples instead of needing to perform a prospective clinical study. If you choose (or must) rely on peer-reviewed literature, make sure you have meticulously documented your search criteria and methods. If there\u2019s any question about whether you should conduct a clinical study, type\/number of samples, or how a study contributes to performance evaluation, consult with your Notified Body early on. Naturally before you conduct any study you\u2019ll need to write a protocol and that\u2019s where ISO 20916:2019 comes into play in concert with the requirements outlined in Annex I, 9.1. Carefully document reasoning behind your collection methods.<\/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-45688d7 elementor-widget elementor-widget-heading\" data-id=\"45688d7\" 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 is an IVD Performance Evaluation Report (PER)?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cad6a9e elementor-widget elementor-widget-text-editor\" data-id=\"cad6a9e\" 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><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-3641 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/IVDR-PER-process-e1628800285648.png\" alt=\"IVDR PER process\" width=\"809\" height=\"762\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/IVDR-PER-process-e1628800285648.png 809w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/IVDR-PER-process-e1628800285648-300x283.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2020\/12\/IVDR-PER-process-e1628800285648-768x723.png 768w\" sizes=\"(max-width: 809px) 100vw, 809px\" \/><\/p><p>\u00a0<\/p><p>With a robust plan to follow and analyses of scientific validity, analytic, and clinical performance completed, it\u2019s time to assemble the final\u00a0<strong>performance evaluation report<\/strong>. Here\u2019s where all that time you spent planning pays off.<\/p><p>Annex XIII, Part A, 1.3.2 of the IVDR spells out the basic requirements for your PER including:<\/p><ul><li>Classification of the IVD, taking safety and performance characteristics into account<\/li><li>Intended purpose of your device and performance or safety claims<\/li><li>Technology on which your IVD is based<\/li><li>Justifying the approach you have taken for gathering clinical evidence<\/li><li>Detailing your literature search methodology, protocol and report<\/li><li>Extent of scientific validity plus all analytical and clinical performance data that\u2019s been evaluated<\/li><li>Evaluation of clinical evidence compared to the current state of the art<\/li><li>Results of Post Market Performance Follow-up (PMPF) studies<\/li><\/ul><p>Performance evaluation reports for Class A &amp; B devices can be updated as needed but the same reports for\u00a0<strong>Class C &amp; D devices must be updated as needed but at least every year.<\/strong><\/p><p><strong>It\u2019s important to remember that evaluation of IVD performance is not a one-time project.<\/strong><\/p><p>Annex XIII, Part B of the IVDR mandates that you continue to monitor the performance of your product throughout its life cycle.\u00a0<strong>Post-market Performance Follow-up (PMPF)<\/strong>\u00a0is the link between the performance evaluation that you have completed and your post-market surveillance system. You must update this throughout the lifecycle of the device.<\/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-4db3270 elementor-widget elementor-widget-heading\" data-id=\"4db3270\" 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?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-588334c elementor-widget elementor-widget-text-editor\" data-id=\"588334c\" 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 much more than a new coat of paint on the IVDD. It\u2019s an entirely new regulation. Oriel STAT A MATRIX can help you make sense of it in several ways. First, if you&#8217;re fairly new to the regulation check out our in-depth\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-ivdr-training-2017-746\">IVDR overview training class<\/a>. If you\u2019re a seasoned auditor, our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-ivdr-auditor-training-2017-746\">IVDR auditor training<\/a>\u00a0may be of interest. Finally, if you simply need help with a gap analysis assessment or getting your technical documentation into shape,\u00a0<a href=\"https:\/\/www.orielstat.com\/consulting\/EU-IVDR-consultants-2017-746\">we can assist<\/a>\u00a0with this too.<\/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-375d07a3 elementor-widget elementor-widget-shortcode\" data-id=\"375d07a3\" 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. Call<\/h6>\n    <\/div>\n    <div id=\"Bottom_icons1_DivOfficePhone\" class=\"row new_update_add\">\n<div class=\"col-lg-6 col-md-12 borderbottom\">\n <div class=\"block-text1\">\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/us-flag.jpg\">\n     <p>\n         <b>US Office<\/b>Washington DC<\/p>\n <\/div>\n <p>\n     <a href=\"tel:1.800.472.6477\">1.800.472.6477<\/a><\/p>\n<\/div>\n<div class=\"col-lg-6 col-md-12\">\n <div class=\"block-text1\">\n     <p>\n         <b>EU Office<\/b>Cork, Ireland<\/p>\n     <img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/11\/eu-flag.jpg\" class=\"img-right-sec\">\n <\/div>\n <p>\n     <a href=\"tel:+353 21 212 8530\">+353 21 212 8530<\/a><\/p>\n<\/div>\n<\/div>\n<\/div><\/div>\n\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<div class=\"elementor-column elementor-col-33 elementor-top-column elementor-element elementor-element-750efe46\" data-id=\"750efe46\" 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-bd67b4b elementor-widget elementor-widget-sidebar\" data-id=\"bd67b4b\" data-element_type=\"widget\" id=\"top\" data-widget_type=\"sidebar.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<section id=\"search-2\" class=\"widget widget_search\"><form role=\"search\" method=\"get\" class=\"search-form\" action=\"https:\/\/www.orielstat.com\/blog\/\">\n\t\t\t\t<label>\n\t\t\t\t\t<span class=\"screen-reader-text\">Search for:<\/span>\n\t\t\t\t\t<input type=\"search\" class=\"search-field\" placeholder=\"Search &hellip;\" value=\"\" name=\"s\" \/>\n\t\t\t\t<\/label>\n\t\t\t\t<input type=\"submit\" class=\"search-submit\" value=\"Search\" \/>\n\t\t\t<\/form><\/section><section id=\"block-2\" class=\"widget widget_block\">\n<figure class=\"wp-block-image size-large\"><a href=\"#mailmunch-pop-545876\"><img decoding=\"async\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2017\/06\/Blog-subscribe.jpg\" alt=\"\"><\/a><\/figure><\/section><section id=\"categories-3\" class=\"widget widget_categories\"><h2 class=\"widget-title\">Search by Topic<\/h2>\n\t\t\t<ul>\n\t\t\t\t\t<li class=\"cat-item cat-item-12\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/all-medical-device-ra-qa\/\">All Category<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-74\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/ai\/\">Artificial Intelligence (AI)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-64\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/auditing\/\">Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-71\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/capa\/\">CAPA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-20\"><a 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>Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe\u2019s new In Vitro Diagnostic Regulation (IVDR 2017\/746) will impose strict new requirements on many IVD manufacturers [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5211,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[27,34],"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\/eu-ivdr-per-best-practices\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe\u2019s new In Vitro Diagnostic Regulation (IVDR 2017\/746) will impose strict new requirements on many IVD manufacturers [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2023-07-03T23:50:36+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-11T16:11:13+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/IVDR-blog-significantchange-300x200-1.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"300\" \/>\r\n\t<meta property=\"og:image:height\" content=\"200\" \/>\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=\"8 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","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-per-best-practices\/","og_locale":"en_US","og_type":"article","og_description":"Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR Unless you are currently selling high-risk IVDs in Europe, chances are your technical documentation has not been scrutinized by a European Notified Body. Soon, you will. Europe\u2019s new In Vitro Diagnostic Regulation (IVDR 2017\/746) will impose strict new requirements on many IVD manufacturers [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2023-07-03T23:50:36+00:00","article_modified_time":"2024-01-11T16:11:13+00:00","og_image":[{"width":300,"height":200,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/IVDR-blog-significantchange-300x200-1.jpg","type":"image\/jpeg"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/#article","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/"},"author":{"name":"usr192162","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553"},"headline":"Understanding EU IVD Performance Evaluation Plan and Report Requirements in the IVDR","datePublished":"2023-07-03T23:50:36+00:00","dateModified":"2024-01-11T16:11:13+00:00","mainEntityOfPage":{"@id":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/"},"wordCount":1403,"publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"articleSection":["Clinical Evaluation Reports","EU IVDR (2017\/746)"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/","url":"https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/","name":"","isPartOf":{"@id":"https:\/\/www.orielstat.com\/blog\/#website"},"datePublished":"2023-07-03T23:50:36+00:00","dateModified":"2024-01-11T16:11:13+00:00","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.orielstat.com\/blog\/eu-ivdr-per-best-practices\/"]}]},{"@type":"WebSite","@id":"https:\/\/www.orielstat.com\/blog\/#website","url":"https:\/\/www.orielstat.com\/blog\/","name":"Oriel STAT A MATRIX Blog","description":"","publisher":{"@id":"https:\/\/www.orielstat.com\/blog\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.orielstat.com\/blog\/?s={search_term_string}"},"query-input":"required name=search_term_string"}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/www.orielstat.com\/blog\/#organization","name":"Oriel STAT A MATRIX Blog","url":"https:\/\/www.orielstat.com\/blog\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/","url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","contentUrl":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2024\/01\/OSAM-Eliquent-logo-color.png","width":1458,"height":1042,"caption":"Oriel STAT A MATRIX Blog"},"image":{"@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/a775f07c9602a3521143e80692594553","name":"usr192162","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.orielstat.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/1412cb81dc66fbc000fb222b1ea52700?s=96&d=mm&r=g","caption":"usr192162"},"url":"https:\/\/www.orielstat.com\/blog\/author\/usr192162\/"}]}},"_links":{"self":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7216"}],"collection":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/comments?post=7216"}],"version-history":[{"count":9,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7216\/revisions"}],"predecessor-version":[{"id":7898,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/posts\/7216\/revisions\/7898"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media\/5211"}],"wp:attachment":[{"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/media?parent=7216"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/categories?post=7216"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.orielstat.com\/blog\/wp-json\/wp\/v2\/tags?post=7216"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}