{"id":7113,"date":"2023-11-02T00:04:29","date_gmt":"2023-11-02T00:04:29","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7113"},"modified":"2024-01-10T23:44:10","modified_gmt":"2024-01-10T23:44:10","slug":"medical-device-cer-mdr-requirements","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/medical-device-cer-mdr-requirements\/","title":{"rendered":"Definitive Guide to Medical Device Clinical Evaluation Reports (CER) and EU MDR Requirements"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7113\" class=\"elementor elementor-7113\" 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\/11\/02\/\">\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\tNovember 2, 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\">Does Your Medical Device CER Meet EU MDR Requirements? Creating a Solid Clinical Evaluation Process\t<\/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\/08\/group-of-managers-discussing-project_Resized1104W736H.jpg\" class=\"attachment-full size-full wp-image-2083\" alt=\"group of managers discussing project\" 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><strong>In this guide:<\/strong><\/p><p><a href=\"#stages\"><u>Stages in the clinical evaluation process<\/u><\/a><br \/><a href=\"#defining\"><u>Defining the scope and drafting a plan <\/u><\/a><br \/><a href=\"#making\"><u>Making sure CER evaluators are qualified<\/u><\/a><br \/><a href=\"#creating\"><u>Creating a literature review protocol<\/u><\/a><br \/><a href=\"#identifying\"><u>Identifying data needed to fulfill plan requirements<\/u><\/a><br \/><a href=\"#crafting\"><u>Crafting a literature search and review strategy<\/u><\/a><br \/><a href=\"#choosing\"><u>Choosing the appropriate data<\/u><\/a><br \/><a href=\"#is\"><u>Is your data valid and relevant?<\/u><\/a><br \/><a href=\"#appraising\"><u>Appraising the clinical data<\/u><\/a><br \/><a href=\"#analyzing\"><u>Analyzing your datasets and drawing conclusions<\/u><\/a><br \/><a href=\"#clinical\"><u>Clinical data analysis<\/u><\/a><br \/><a href=\"#alignment\"><u>Alignment between clinical evaluation, IFU, and risk management<\/u><\/a><br \/><a href=\"#are\"><u>Are additional clinical investigations needed?<\/u><\/a><br \/><a href=\"#writing\"><u>Writing your CER and when to update it<\/u><\/a><br \/><a href=\"#compiling\"><u>Compiling the clinical evaluation report<\/u><\/a><br \/><a href=\"#template\"><u>Creating your EU CER template<\/u><\/a><br \/><a href=\"#create\"><u>Create a CER checklist<\/u><\/a><br \/><a href=\"#how\"><u>How often your CER should be updated<\/u><\/a><\/p><p>\u00a0<\/p><p>Medical device regulatory professionals have been grappling with tighter requirements for clinical data to support clinical evidence since MEDDEV 2.7\/1 Rev. 4 was released in mid-2016. Now that the European Medical Device Regulation (2017\/745) is nearing implementation, clinical evaluation reports (CERs) have taken on new urgency.<\/p><p>Regardless of whether you are making updates to existing CERs or building one for a product launch, you want to make sure that you don\u2019t experience any nasty surprises during your Notified Body audit and technical documentation review.\u00a0<strong>The first step is to create a robust clinical evaluation plan.<\/strong><\/p><p>As you probably know, medical device manufacturers can fulfill clinical evidence requirements using one or more of the following:<\/p><ul><li>Premarket clinical studies (the mostoption, but necessary for new technology\/indications)<\/li><li>Literature searches for existing clinical studies for equivalent devices (<\/li><li>Compliance with harmonized standards (e.g., IEC 60601-1 on electrical safety)<\/li><li>Data generated from PMS activities and postmarket clinical studies, such as postmarket clinical follow-up (PMCF)<\/li><li>Clinical investigations<\/li><li>Postmarket clinical follow-up<\/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-0d21699 elementor-widget elementor-widget-menu-anchor\" data-id=\"0d21699\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\nbody.elementor-page .elementor-widget-menu-anchor{margin-bottom:0}<\/style>\t\t<div id=\"stages\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\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<h3>Stages in the Medical Device Clinical Evaluation Process<\/h3><p>Before we go into detail on the process, here\u2019s an overview of the various stages outlined in\u00a0MEDDEV 2.7\/1 Rev. 4\u00a0and where you will find guidance on each stage.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2089 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Stages-in-the-Medical-Device-Clinical-Evaluation-Process.png\" alt=\"Stages in the Medical Device Clinical Evaluation Process\" width=\"1021\" height=\"512\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Stages-in-the-Medical-Device-Clinical-Evaluation-Process.png 1021w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Stages-in-the-Medical-Device-Clinical-Evaluation-Process-300x150.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Stages-in-the-Medical-Device-Clinical-Evaluation-Process-768x385.png 768w\" sizes=\"(max-width: 1021px) 100vw, 1021px\" \/><\/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-2a9eddb elementor-widget elementor-widget-menu-anchor\" data-id=\"2a9eddb\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"defining\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7662118 elementor-widget elementor-widget-text-editor\" data-id=\"7662118\" 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<h3>Clinical Evaluation Stage 0: Defining the Scope and Drafting a Clinical Evaluation Plan<\/h3><p>Published literature is a key component of the clinical data gathered by most companies. While it may be tempting to dig in and start doing literature searches straight away, it\u2019s important that you understand what is needed in the first place. This \u201cscoping\u201d process is vital because you will need to explain and defend it to your Notified Body, and you will need to replicate it in the future.<\/p><p>Your clinical evaluation plan will define the extent of information gathered based on the General Safety and Performance Requirements in Annex I of the MDR.\u00a0MEDDEV 2.7\/1 Rev. 4\u00a0defines numerous aspects that should be considered in a thorough clinical evaluation plan. You can find much more detail on the elements to be considered during Stage 0 in Section 7 of the MEDDEV, which delineates between new medical devices and those that already have CE Marking.<\/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-412aa2c elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"412aa2c\" data-element_type=\"widget\" data-widget_type=\"divider.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-divider{--divider-border-style:none;--divider-border-width:1px;--divider-color:#0c0d0e;--divider-icon-size:20px;--divider-element-spacing:10px;--divider-pattern-height:24px;--divider-pattern-size:20px;--divider-pattern-url:none;--divider-pattern-repeat:repeat-x}.elementor-widget-divider .elementor-divider{display:flex}.elementor-widget-divider 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100%;-webkit-mask-repeat:var(--divider-pattern-repeat);mask-repeat:var(--divider-pattern-repeat);background-color:var(--divider-color);-webkit-mask-image:var(--divider-pattern-url);mask-image:var(--divider-pattern-url)}.elementor-widget-divider--no-spacing{--divider-pattern-size:auto}.elementor-widget-divider--bg-round{--divider-pattern-repeat:round}.rtl .elementor-widget-divider .elementor-divider__text{direction:rtl}.e-con-inner>.elementor-widget-divider,.e-con>.elementor-widget-divider{width:var(--container-widget-width,100%);--flex-grow:var(--container-widget-flex-grow)}<\/style>\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0e0084b elementor-widget elementor-widget-text-editor\" data-id=\"0e0084b\" 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>MEDDEV 2.7\/1 Rev. 4 states<\/strong>: Clinical evaluation is necessary and important because it ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime that the medical device is on the market.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d2d52fb elementor-widget-divider--view-line elementor-widget elementor-widget-divider\" data-id=\"d2d52fb\" data-element_type=\"widget\" data-widget_type=\"divider.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-divider\">\n\t\t\t<span class=\"elementor-divider-separator\">\n\t\t\t\t\t\t<\/span>\n\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8a6d4be elementor-widget elementor-widget-text-editor\" data-id=\"8a6d4be\" 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>Here are some of the aspects that need to be included in your CER scoping process. Some of these issues apply only to \u201cnew\u201d devices getting CE Marking for the first time.<\/p><ul><li>Device description \u2013 see Appendix A3 of the MEDDEV<\/li><li>CE Marking status of the device<\/li><li>Where the device is marketed outside Europe<\/li><li>Design features, names, models, sizes, components, etc.<\/li><li>Intended use of the device and special indications or target populations<\/li><li>Risk management documentation<\/li><li>Current device\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\">State Of The Art<\/a><\/li><li>Data sources and types to be used<\/li><li>Information needed for demonstrating\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-device-equivalency\/\">Equivalence<\/a> (new devices only)<\/li><li>Design, manufacturing, materials, or labeling changes (devices with CE Marking)<\/li><li>Any newly emerged clinical concerns (devices with CE Marking)<\/li><li>New data generated from PMS (devices with CE Marking)<\/li><\/ul><p>Of course, the amount of data deemed necessary to meet sufficient clinical evidence and the General Safety and Performance Requirements will also be determined by the nature of the device, its stage in the life cycle, and its safety record.<\/p><p>Article 1(a) of Annex XIV in the MDR provides additional detail about what the clinical evaluation plan should include. You\u2019ll want to study this in addition to Section 7 of the MEDDEV before crafting your plan.<\/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-124a231 elementor-widget elementor-widget-menu-anchor\" data-id=\"124a231\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"making\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-139cc82 elementor-widget elementor-widget-text-editor\" data-id=\"139cc82\" 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<h3>Making Sure CER Evaluators Are Qualified<\/h3><p>Before you dive into planning, you\u2019ll also want to know that the MEDDEV sets some pretty specific guidelines for who can take on this important task. Evaluating clinical data is serious business, and regulators want to ensure that the people performing the evaluation are well qualified to do so. Section 6.4 of the MEDDEV outlines the basic requirements. Evaluators should have an appropriate college degree plus 5 years of professional experience or 10 years of experience if a degree is not a prerequisite. In addition, Section 6.4 goes on to say that evaluators should have knowledge of:<\/p><ul><li>Research methodology<\/li><li>Information management<\/li><li>Regulatory requirements<\/li><li>Medical writing<\/li><li>Application of the specific device technology<\/li><li>Diagnosis and management of the conditions to be diagnosed or managed by the device<\/li><\/ul><p>These qualifications will need to be documented and you can be certain that your Notified Body will review documentation related to reviewer qualifications.<\/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-210e986 elementor-widget elementor-widget-menu-anchor\" data-id=\"210e986\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"creating\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4d0324c elementor-widget elementor-widget-text-editor\" data-id=\"4d0324c\" 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<h3 class=\"elementor-heading-title elementor-size-default elementor-inline-editing pen\" contenteditable=\"true\" data-elementor-setting-key=\"title\" data-page-optimizer-editable=\"true\" data-pen-placeholder=\"Type Here...\">Creating an EU CER Literature Review Protocol and Reviewing Medical Device Clinical Data<\/h3><p>Once you have created a robust clinical evaluation plan for your medical device(s), it\u2019s time to get busy figuring out what data you need, drafting a protocol, and then taking stock of that data. This is considered Stages 1 and 2 of the CER process and the specifics can be found in\u00a0MEDDEV 2.7\/1 rev. 4, as shown 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-ad10559 elementor-widget elementor-widget-menu-anchor\" data-id=\"ad10559\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"identifying\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4c2f571 elementor-widget elementor-widget-text-editor\" data-id=\"4c2f571\" 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<h3>\u00a0<\/h3><h3>Clinical Evaluation Stage 1:<br \/>Identifying Data Needed to Fulfill the Requirements of Your Plan<\/h3><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2139 size-large\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage1-1024x517.png\" alt=\"Clinical Evaluation Stage 1\" width=\"640\" height=\"323\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage1.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage1-300x151.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage1-768x388.png 768w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/p><p>There are two broad categories of clinical data.<\/p><p><strong>1 \u2013 Data\u00a0<em><u>not<\/u>\u00a0<\/em>generated by your company\u00a0<\/strong><em>(retrieved from online literature searches and other offline data)<\/em><\/p><p><strong>2 \u2013 Data generated by your company, which can include:<\/strong><\/p><ul><li>Premarket clinical investigations, including bench testing reports<\/li><li>Postmarket data gathered from risk management and PMS activities, including PMCF studies, device registries, and more<\/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-1f61b86 elementor-widget elementor-widget-menu-anchor\" data-id=\"1f61b86\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"crafting\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d545157 elementor-widget elementor-widget-text-editor\" data-id=\"d545157\" 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<h3>\u00a0<\/h3><h3>Crafting a CER Literature Search and Review Strategy<\/h3><p>\u00a0<\/p><p>For many companies, the data retrieved from literature searches will represent most, if not all, of the data they collect. That\u2019s why it is so critically important that you develop a literature search strategy that is robust and can be replicated during subsequent updates to your CER. The output of your search and review should obviously include literature on your device and any identified\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-device-equivalency\/\">equivalent device<\/a>, plus a review of the current state of the art. Your literature search protocol should include the following elements (for more specifics on this, see Appendix A5 in MEDDEV 2.7\/1 Rev. 4):<\/p><ul><li>Sources of data you will use (e.g., MEDLINE\/PubMed, Embase, Google Scholar, ResearchGate, internet searches, etc.)<\/li><li>The methodology you plan to use for searches<\/li><li>Exact search terms and parameters (e.g., dates) used to search scientific databases and the internet<\/li><li>Your specific selection or exclusion criteria along with justification for each<\/li><li>How you will address duplication of data from multiple sources<\/li><li>How you will ensure data integrity (e.g., QC methods or second reviewers)<\/li><li>How you will appraise each data source and its relevance to your device<\/li><li>How you will go about analyzing and processing the data<\/li><\/ul><p>You should think of your plan as you would a standard operating procedure (SOP) or a detailed instruction. As an example, if you were to leave the company a year from now, your successor should be able to read your protocol and understand exactly what was done during the previous update.<\/p><p>Make sure you treat the literature searches related to device equivalence as a separate activity from the searches on current state of the art. Separately define and track search terms used, database sources, date parameters, etc. Also, be cognizant that your idea of \u201cstate of the art\u201d may differ from reality \u2013 here\u2019s\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\">why<\/a>. Before finalizing your protocol, test it. Identify known papers relevant to your device or current state of the art and then test those search parameters to make sure those known papers appear in your search results.<\/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-d597134 elementor-widget elementor-widget-menu-anchor\" data-id=\"d597134\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"relationship\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-656afea elementor-widget elementor-widget-text-editor\" data-id=\"656afea\" 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<h3>\u00a0<\/h3><h3>Review It All: The Favorable\u2026and the Not So Favorable<\/h3><p>\u00a0<\/p><p>Your literature searches should be extremely thorough and encompass a breadth of search criteria. They also need to be documented in detail so the results can be independently verified and replicated. Your selection of literature should be objective (the good and the bad) and justifiable. Nearly every published study has citations that may lead you to additional relevant data. Again, this is where planning and staying within your device search parameters become really important, because you can very quickly wander down a virtual rabbit hole and not be able to replicate how you got there.<\/p><p>While most publications are available in English (e.g., 93% on MEDLINE), make some attempts to do basic searches in French, German, or Japanese using online translation tools. Obviously, if you work for a larger company that has offices in Europe or Asia, getting help from native-speaking colleagues would be ideal. While the odds are good that you will find what you need in English, you might uncover valuable data that can be translated and further appraised if needed. \u00a0Also, if you are updating an existing CER, we recommend that you start your search a few weeks before the end date of previous search to ensure you don\u2019t miss anything that may have been added at the very end of your previous search period but had not yet been indexed online.<\/p><p>Keep in mind that some data may be publicly available but not easily accessible online. For instance, the label and IFU of a competitive device (if using one) may yield useful information. Also, presentations made at industry conferences may provide information that is not available (or has not yet been published) online.<\/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-fdef9ab elementor-widget elementor-widget-menu-anchor\" data-id=\"fdef9ab\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"choosing\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-45a66d8 elementor-widget elementor-widget-text-editor\" data-id=\"45a66d8\" 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<h3>\u00a0<\/h3><h3>Clinical Evaluation Stage 2: <em>Choosing the Appropriate Data Sets Also Requires a Plan<\/em><\/h3><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2090 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical-Evaluation-Stage-2_-Choosing-the-Appropriate-Data-Sets-Also-Requires-a-Plan.png\" alt=\"\" width=\"1021\" height=\"515\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical-Evaluation-Stage-2_-Choosing-the-Appropriate-Data-Sets-Also-Requires-a-Plan.png 1021w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical-Evaluation-Stage-2_-Choosing-the-Appropriate-Data-Sets-Also-Requires-a-Plan-300x151.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical-Evaluation-Stage-2_-Choosing-the-Appropriate-Data-Sets-Also-Requires-a-Plan-768x387.png 768w\" sizes=\"(max-width: 1021px) 100vw, 1021px\" \/><\/p><p>\u00a0<\/p><p>During Stage 0, you came up with a clinical evaluation plan focused on\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-cer-medical-device-clinical-data\/\"><em>determining which data<\/em><\/a>\u00a0you need and from what sources. In Stage 2, your focus will turn to\u00a0<strong><em>choosing the right data<\/em><\/strong>\u00a0among the data sets you have found. This requires yet more planning. Your data appraisal plan should address:<\/p><ul><li>Criteria for determining the quality, relevance, and validity of the data<\/li><li>How you will weigh the data related to favorable and unfavorable results<\/li><\/ul><p>According to Section 9.2 of MEDDEV 2.7\/1 Rev. 4, the criteria you select should \u201creflect the nature, history and intended clinical use of the device.\u201d This is something you must document and justify based on current state of the art.<\/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-8513568 elementor-widget elementor-widget-menu-anchor\" data-id=\"8513568\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"is\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4ed208e elementor-widget elementor-widget-text-editor\" data-id=\"4ed208e\" 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<h3>\u00a0<\/h3><h3>Is Your Data Valid and Relevant?<\/h3><p>\u00a0<\/p><p>So you found plenty of data in Stage 1 that seem relevant to your device and its intended purpose. But how do you know if the quality is good? At first glance, you don\u2019t. Sure, a paper published in\u00a0<em>The Lancet<\/em>\u00a0is instantly credible, but the quality of a publication cannot serve as the sole rationale for selection. Ultimately you need to dive headfirst into the pool and do investigative research of your own to appraise the quality of the data.<\/p><p>Doing this requires some skill, because it is on you to evaluate the methodology used to collect the data and therefore determine its scientific merit. As part of this appraisal process you will also need to weigh the contribution of each data set to the overall clinical evaluation. Section 9.3 of the MEDDEV contains seven pages of advice on how to evaluate the methodological quality and scientific validity of data sets.<\/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-3f0ca48 elementor-widget elementor-widget-menu-anchor\" data-id=\"3f0ca48\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"relationship\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-34d2bc9 elementor-widget elementor-widget-text-editor\" data-id=\"34d2bc9\" 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<h3>\u00a0<\/h3><h3>A Higher Bar for Medical Device Equivalency Under the MDR<\/h3><p>\u00a0<\/p><p>Many companies use equivalency claims to avoid having to conduct redundant pre- or postmarket clinical studies that prove safety and performance. This part of the clinical evaluation process is not new. What is new is the level of scrutiny those comparative evaluations will endure. The clinical evaluation requirements in the existing Medical Devices Directive (93\/42\/EEC) and MEDDEV 2.7\/1 Rev. 3 largely favored device equivalency but did not define it. Thus, some companies took a liberal view of \u201cequivalent.\u201d When MEDDEV 2.7\/1 Rev. 4 was released in mid-2016, it gave manufacturers a lot less latitude for determining which devices could be considered equivalent. In fact, Appendix A1 in Rev. 4 is quite clear about the clinical, technical, and biological characteristics your device must have in common with an \u201cequivalent\u201d device.<\/p><p>The MDR furthers tightens the screws for Class III and implantable devices, requiring a more in-depth assessment and making it more challenging to leverage competitor data for new devices. That\u2019s because Article 61, Section 5 of the MDR requires manufacturers of such devices to have access to the full technical documentation of the competitive device(s). It also instructs Notified Bodies to ask for proof that you have a contract in place granting you permanent access to that technical documentation. Good luck with that.<\/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-63fbaeb elementor-widget elementor-widget-menu-anchor\" data-id=\"63fbaeb\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"appraising\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9a9c39 elementor-widget elementor-widget-text-editor\" data-id=\"f9a9c39\" 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<h3>\u00a0<\/h3><h3>Appraising the Medical Device Clinical Data<\/h3><p>\u00a0<\/p><p>With an appraisal plan created and a grip on how to execute it, you can begin the hard work of appraising the data you have found. This appraisal must be done based on the complete text of publications you find, not just by reading the abstracts or summaries. For each document you appraise, you are required to document your appraisal of it to the point that it could reasonably be reviewed by others. The appraisal results should also support conclusions you are making about clinical safety and clinical performance of the finished device (e.g., citing non-device-related literature would be ranked low for appraisal).<\/p><p>Appendix A6 in MEDDEV 2.7\/1 Rev. 4 can be helpful in performing your appraisal of data. It provides some examples of red flags that should make you pause, including clinical data that:<\/p><ul><li>Lacks basic information such as the methods used, number of patients, identity of products, etc.<\/li><li>Has data sets that are too small to be statistically significant<\/li><li>Contains data that applies improper statistical methods<\/li><li>Employs studies that lack adequate controls<\/li><li>Has an improper collection of mortality and serious adverse event data<\/li><li>Depicts a misrepresentation by the authors<\/li><\/ul><p>The issue of evaluating statistical methods and significance intimidates many RA\/QA professionals. If you feel uncomfortable about your \u201cstats skills\u201d for conducting statistical analysis or reviewing statistical information, hire some outside expertise to evaluate these specific aspects. Better to invest in doing that now rather than have a Notified Body reviewer challenge your appraisal 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-5b431e5 elementor-widget elementor-widget-menu-anchor\" data-id=\"5b431e5\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"analyzing\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-81761d3 elementor-widget elementor-widget-text-editor\" data-id=\"81761d3\" 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<h3>Analyzing Your Medical Device Clinical Datasets and Drawing Conclusions<\/h3><p>Anyone who has ever researched and compiled an entire European clinical evaluation report knows that the devil is in the details. Finding appropriate clinical data is not necessarily the most challenging aspect of the process \u2013 it\u2019s the appraisal and analysis of that data that causes regulatory heartburn.\u00a0<\/p><p>Many professionals interchange appraisal and analysis, but those are actually two distinct steps in the process. When you appraise data, you are looking to make sure it has statistically significant data sets, uses proper statistical methods, has adequate controls, and properly collects mortality and\/or serious adverse event data.<\/p><p>During the analysis stage (Stage 3) you will really dig in and conduct a comprehensive assessment to determine if the data you have found meets clinical safety requirements, clinical performance requirements, and General Safety and Performance Requirements (GSPR) of the EU Medical Device Regulation (MDR). You will evaluate the following:<\/p><ul><li>Is the performance bench testing<\/li><li>Is the risk-benefit ratio appropriate based on the intended purpose of the device?<\/li><li>Can the device actually achieve all performance claims made by the manufacturer?<\/li><li>Are the materials (e.g., IFU) supplied by the manufacturer adequate to describe the intended purpose and mitigate risk?<\/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-804b013 elementor-widget elementor-widget-menu-anchor\" data-id=\"804b013\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"clinical\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-2ef25d2 elementor-widget elementor-widget-text-editor\" data-id=\"2ef25d2\" 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<h3>\u00a0<\/h3><h3>Clinical Evaluation Stage 3:\u00a0<em>Clinical Data Analysis<\/em><\/h3><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2146 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage3.png\" alt=\"Clinical Evaluation Reports Stage 3\" width=\"1022\" height=\"513\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage3.png 1022w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage3-300x151.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage3-768x386.png 768w\" sizes=\"(max-width: 1022px) 100vw, 1022px\" \/><\/p><p>During Stage 3 you are expected to analyze the data to ensure the clinical evaluation demonstrates that any risks are minimal and acceptable. You also need to consider all aspects of the device\u2019s intended purpose. You\u2019ll find more detail on this in Section 10.2 of\u00a0MEDDEV 2.7\/1 Rev. 4, and in Annex AVII. You will identify gaps related to:<\/p><ul><li>Understanding the interaction between the device and body<\/li><li>The completeness of the data available<\/li><li>Type and adequacy of patient monitoring<\/li><li>Number and severity of adverse events<\/li><li>Severity and history of the condition being treated or diagnosed<\/li><li>Current standards of care<\/li><li>Other factors<\/li><\/ul><p>Data from the literature you have appraised is often put into Excel tables to be analyzed. It\u2019s a convenient way to compare different study details, patient populations, endpoints, adverse events, etc. This can end up being a sizable amount of data unto itself, but certain aspects can be parsed into \u201cbite-sized\u201d tables focused on particular issues. While spreadsheets are not especially wonderful for narrative explanations, they are useful as quick comparative tools and are extremely helpful in noting differences between studies when writing the summary.<\/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-691478d elementor-widget elementor-widget-menu-anchor\" data-id=\"691478d\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"alignment\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ce6a0ed elementor-widget elementor-widget-text-editor\" data-id=\"ce6a0ed\" 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<h3>\u00a0<\/h3><h3>Alignment Between Clinical Evaluation, IFU, and Risk Management<\/h3><p>\u00a0<\/p><p>Your analysis should also examine the alignment between the clinical evaluation, labeling\/instructions for use (IFU), and the risk management file, as well as the current\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/eu-mdr-state-of-the-art\/\">state of the art<\/a>. Reviewers need to pay very close attention to make sure that, for example, the IFU and promotional materials are harmonized with regard to medical conditions and target populations. This analysis also needs to be consistent with the appraisal you conducted during Stage 2. Here\u2019s what Appendix A7.1 of MEDDEV 2.7\/1 Rev. 4 has to say about it:<\/p><p><em>\u201cThe information materials supplied by the manufacturer (including label, IFU, available promotional materials including accompanying documents possibly foreseen by the manufacturer), should be reviewed to ensure they are consistent with the relevant clinical data appraised in Stage 2 and that all the hazards, information on risk mitigation, and other clinically relevant information have been identified appropriately.\u201d<\/em><\/p><p>It is expected that you will conduct the analysis with input from your risk management files and appropriate standards such as IEC 60601-1 (electrical safety) and EN 62366 (usability). The goal, of course, is to demonstrate that any risks associated with the intended purpose of your device are acceptable when weighed against the benefits it offers the patient or user.<\/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-877499e elementor-widget elementor-widget-menu-anchor\" data-id=\"877499e\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"are\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-8074934 elementor-widget elementor-widget-text-editor\" data-id=\"8074934\" 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<h3>\u00a0<\/h3><h3>Are Additional Clinical Investigations Needed?<\/h3><p>\u00a0<\/p><p>How much is enough? There is no definitive rule that determines whether you have collected enough clinical data to meet the General Safety and Performance Requirements (GSPR) of the EU Medical Device Regulation (MDR). You need to conduct a detailed gap analysis and come to your own conclusion about whether supplemental clinical investigations will be required. At this time, you should also determine whether there are residual risks and uncertainties. This might include factors related to rare complications, long-term performance, or safety under widespread use. You\u2019ll find more information on this in Appendix A2 of MEDDEV 2.7\/1 Rev. 4.<\/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-42365ba elementor-widget elementor-widget-menu-anchor\" data-id=\"42365ba\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"writing\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-12ec9d5 elementor-widget elementor-widget-text-editor\" data-id=\"12ec9d5\" 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<h3>Writing Your EU MDR Clinical Evaluation Report and When to Update It<\/h3><p>You\u2019ve done\u00a0a lot\u00a0of work to get this far. Writing a medical device clinical evaluation report (CER) is the culmination of a monumental effort to conduct literature searches, find\/review literature, and\/or conduct original clinical investigations. Data must be sourced, appraised, analyzed, and then summarized into your CER. This final process \u2013 writing the CER itself \u2013 is commonly referred to as Stage 4.<\/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-83d8846 elementor-widget elementor-widget-menu-anchor\" data-id=\"83d8846\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"compiling\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c2cf263 elementor-widget elementor-widget-text-editor\" data-id=\"c2cf263\" 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<h3>\u00a0<\/h3><h3>Clinical Evaluation Stage 4:\u00a0<em>Compiling the CER<\/em><\/h3><p>\u00a0<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2150 size-full\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage4.png\" alt=\"\" width=\"1018\" height=\"511\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage4.png 1018w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage4-300x151.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Clinical_Eval-Stage4-768x386.png 768w\" sizes=\"(max-width: 1018px) 100vw, 1018px\" \/><\/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-ae539a8 elementor-widget elementor-widget-menu-anchor\" data-id=\"ae539a8\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"template\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-74b07d9 elementor-widget elementor-widget-text-editor\" data-id=\"74b07d9\" 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<h3>\u00a0<\/h3><h3>Creating Your EU CER Template<\/h3><p>\u00a0<\/p><p>Because the contents of a clinical evaluation report vary according to the nature and history of the device being evaluated, neither MEDDEV 2.7\/1 Rev. 4 nor the EU MDR provide a detailed CER template. However, Appendix A9 of the MEDDEV does provide nearly six pages of guidance on what the structure of your CER should look like and what content it should contain. Here\u2019s the basic outline.<\/p><p>1 \u2013 Summary<\/p><p>2 \u2013 Scope of the clinical evaluation<\/p><p>3 \u2013 Clinical background, current knowledge, and state of the art<\/p><p>4 \u2013 Device under evaluation:<\/p><ul><li>Type of evaluation<\/li><li>Demonstration of equivalence, if applicable<\/li><li>Clinical data generated and held by manufacturer<\/li><li>Clinical data generated from literature searches<\/li><li>Summary and appraisal of clinical data<\/li><li>Analysis of the clinical data<\/li><\/ul><p>5 \u2013 Conclusions<\/p><p>6 \u2013 Date of next clinical evaluation<\/p><p>7 \u2013 Dates and signatures<\/p><p>8 \u2013 Qualification of the responsible evaluators<\/p><p>9 \u2013 References<\/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-747bb3d elementor-widget elementor-widget-menu-anchor\" data-id=\"747bb3d\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"create\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f9520b8 elementor-widget elementor-widget-text-editor\" data-id=\"f9520b8\" 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<h3>\u00a0<\/h3><h3>Create a CER Checklist: Do You Have Everything Covered?<\/h3><p>\u00a0<\/p><p>You\u2019ve done all the hard work, but are you sure you didn\u2019t forget anything? The checklist found in Appendix A10 should help. Here\u2019s an abbreviated version of it. (Note that this is only a partial list, to give you a flavor of what your CER checklist should include.)<\/p><ul><li>Is the report understandable to a third party and does it provide sufficient detail?<\/li><li>Is all data generated, mentioned, and summarized in the report?<\/li><li>If claiming equivalence, are differences adequately disclosed and explained as to why you don\u2019t expect them to affect safety and performance?<\/li><li>Has the latest PMS\/PMCF data been taken into account and summarized?<\/li><li>Is current state of the art explained and substantiated?<\/li><li>Are undesirable side effects and the risk\/benefit profile acceptable when compared to state of the art?<\/li><li>Is conformity to MDR General Safety and Performance Requirements stated?<\/li><li>Do informational materials supplied correspond with contents of the report?<\/li><li>Does the report identify all residual risks or uncertainties that should be addressed in PMS\/PMCF studies?<\/li><li>Is the report dated and qualification of the evaluators included?<\/li><\/ul><p>If the CER covers several models, sizes, settings, or situations, are the conclusions correct for:<\/p><ul><li>All devices, sizes, models, and settings?<\/li><li>Every medical indication?<\/li><li>The entire target population and all intended users?<\/li><li>The duration of product use, including repeat exposure?<\/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-bf963db elementor-widget elementor-widget-menu-anchor\" data-id=\"bf963db\" data-element_type=\"widget\" data-widget_type=\"menu-anchor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div id=\"how\" class=\"elementor-menu-anchor\"><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c7a0113 elementor-widget elementor-widget-text-editor\" data-id=\"c7a0113\" 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<h3>How Often Your EU CER (Clinical Evaluation Reports) Should Be Updated<\/h3><p>Section 6.2.3 of MEDDEV 2.7\/1 Rev. 4 provides guidance to manufacturers on how often to update clinical evaluations. It says that the \u201cmanufacturer should define and justify the frequency\u201d of CER updates. Typically, this is done in concert with your Notified Body audit and certificate renewal, but that predefined schedule can be tossed out the window if your postmarket surveillance activities uncover new risks.<\/p><p>Shown below is an example of how you could rationalize the frequency of updates to your CER. This sample shows a simple evaluation table for an ECG machine that is well established on the market and has decent clinical history. You can, of course, create your own rating system with more factors, and you could weight these factors as well. We\u2019ve kept the table simple in order to illustrate the point that your NB wants to see that you have a systematic approach to determining your CER update schedule.<\/p><p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-2113 size-large\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Factors-to-consider-when-establishing-a-CER-Update-Schedule-1024x789.png\" alt=\"Factors to consider when establishing a CER Update Schedule\" width=\"640\" height=\"493\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Factors-to-consider-when-establishing-a-CER-Update-Schedule-1024x789.png 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Factors-to-consider-when-establishing-a-CER-Update-Schedule-300x231.png 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Factors-to-consider-when-establishing-a-CER-Update-Schedule-768x592.png 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2019\/08\/Factors-to-consider-when-establishing-a-CER-Update-Schedule.png 1025w\" sizes=\"(max-width: 640px) 100vw, 640px\" \/><\/p><p>As you can see in this example, even though this device is an established ECG with good clinical history, due to its inherently complexity, where it is used on the body, and the target population on which it is used, updating the CER every few years is still recommended.<\/p><p>Regardless of your proposed rationalization for the update schedule, you\u00a0<strong>must<\/strong>\u00a0update the CER after getting new information from your postmarket surveillance activities that might change your current evaluation. For example, safety reports, newly published literature, or PMCF studies may uncover previously unknown safety concerns. Data from these sources must be to evaluated because it may change your risk\/benefit profile. Remember that Annex XIV, Part B of the MDR mandates that your PMCF plan specify the \u201cmethods and procedures for proactively collecting and evaluating clinical data.\u201d<\/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-0644c8b elementor-widget elementor-widget-text-editor\" data-id=\"0644c8b\" 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<h3>Your CER Is a Critical Component of Your Technical Documentation<\/h3><p>Along with your risk management documentation and postmarket surveillance plan, the clinical evaluation report is a centerpiece of the technical documentation needed for CE Marking. While we think of the CER primarily as a regulatory exercise, it\u2019s important to remember that the ultimate goal is the advancement of patient safety. Looking at it through that lens will help you focus on the right things and create a CER in full compliance with MEDDEV 2.7\/1 Rev. 4 and the EU MDR (2017\/745).<\/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-9cfb0ca elementor-widget elementor-widget-text-editor\" data-id=\"9cfb0ca\" 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<h3>Advance Your Knowledge of Clinical Evaluation Reports<\/h3><p>If you found this article to be informative and you want to take the next step in advancing your knowledge of all things CER, consider our\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/clinical-evaluation-report-EU-CER-training\">EU CER training class<\/a>. Our consultants are also available to help you with\u00a0<a href=\"https:\/\/www.orielstat.com\/consulting\/MEDDEV-2-7-1-Rev4-transition\">EU CER development and gap analysis<\/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-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. 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Requirements? Creating a Solid Clinical Evaluation Process In this guide: Stages in the clinical evaluation processDefining the scope and drafting a plan Making sure CER evaluators are qualifiedCreating a literature review protocolIdentifying data needed to fulfill plan requirementsCrafting a literature search and review strategyChoosing the appropriate dataIs [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":2083,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[27,16],"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>Definitive Guide to Medical Device Clinical Evaluation Reports (CER) and EU MDR Requirements<\/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\/medical-device-cer-mdr-requirements\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"Definitive Guide to Medical Device Clinical Evaluation Reports (CER) and EU MDR Requirements\" \/>\r\n<meta property=\"og:description\" content=\"Does Your Medical Device CER Meet EU MDR Requirements? 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