{"id":6878,"date":"2020-02-07T13:14:07","date_gmt":"2020-02-07T13:14:07","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6878"},"modified":"2021-04-06T12:36:40","modified_gmt":"2021-04-06T12:36:40","slug":"writing-a-clinical-evaluation-report-5-quick-tips","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/","title":{"rendered":"Writing a Clinical Evaluation Report: 5 Quick Tips"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f18b6ca98dc\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f18b6ca98dc\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/#1_Define_a_CER_protocol_and_strategy\" title=\"1. Define a CER protocol and strategy\">1. Define a CER protocol and strategy<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/#2_Demonstrate_equivalence\" title=\"2. Demonstrate equivalence\">2. Demonstrate equivalence<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/#3_Evaluate_literature_review_data\" title=\"3. Evaluate literature review data\">3. Evaluate literature review data<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/#4_Determine_requirement_for_clinical_investigation\" title=\"4. Determine requirement for clinical investigation\">4. Determine requirement for clinical investigation<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/#5_Monitor_post-market_activities\" title=\"5. Monitor post-market activities\">5. Monitor post-market activities<\/a><\/li><\/ul><\/nav><\/div>\n<p><em>Sophie Laurenson, <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">healthcare<\/a> &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy.<\/em><\/p>\n<p>The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document essential for CE Marking. Here are expert tips on what to take into account to defining a robust CER strategy.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"1_Define_a_CER_protocol_and_strategy\"><\/span>1. Define a CER protocol and strategy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Identify the Essential Requirements (Safety and Performance Requirements in the MDR) that need to be supported by clinical evidence. Define metrics relative to performance, safety and risk\/benefit endpoints.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"2_Demonstrate_equivalence\"><\/span><strong>2. Demonstrate equivalence<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Equivalence is determined based on the comparison between a medical device and other pre-existing, similar CE-marked devices. The demonstration of equivalence is evaluated on relevant parameters that are defined by the manufacturer. The rationale for equivalence must be fully explained in the CER. The criteria for equivalence have become complex and stringent, with stronger connections to the Essential Requirements. It is critical to avoid the common mistake of selecting equivalent devices that are not relevant to your product. Documented data must be identified and analyzed for each equivalent device and for the differences between devices.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"3_Evaluate_literature_review_data\"><\/span><strong>3. Evaluate literature review data<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">If equivalency can be demonstrated adequately, clinical data extracted from literature on previous studies is a valuable tool in compiling a CER. However, it is critical that literature surveys are conducted in a systematic process:<\/p>\n<p>\u2022 Prepare a comprehensive protocol for the literature review,<br \/>\n\u2022 Define inputs and parameters such as databases, search terms and exclusion criteria (languages, study type \/ design, study setting, endpoints),<br \/>\n\u2022 Define the required safety and performance criteria based on the equivalent products and risk analysis,<br \/>\n\u2022 Systematically gather relevant articles from different data sources,<br \/>\n\u2022 Analyze the data using an objective method such as a framework and using multiple reviewers, and,<br \/>\n\u2022 Document conclusions of the literature evaluation for inclusion in the CER document.<\/p>\n<p><strong>Also read: <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-clinical-evaluation-report-writer-for-your-medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">How to hire a Clinical Evaluation Report writer for your medical device<\/a>\u00a0<\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"4_Determine_requirement_for_clinical_investigation\"><\/span>4. Determine requirement for clinical investigation<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">The requirement for a clinical investigation is determined by the risk profile of the device. High risk and Class III devices must be subject to a clinical investigation. Novelty is also a determining factor, and devices based on innovative technologies or for a new intended use with require clinical investigation. The available clinical evidence must address all the pertinent ERs. This can be ensured by sharing the Clinical Investigational Plan (CIP) with the relevant NB prior to implementation.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"5_Monitor_post-market_activities\"><\/span>5. <strong>Monitor post-market activities<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p class=\"_04xlpA direction-ltr align-start para-style-body\">Under the MDR, PMS activities must be adequately planned and documented in the CER. The processes for evaluating ongoing clinical data and updating CERs must also be documented. To ensure that the CER remains relevant throughout the product lifecycle, it must be updated regularly through a documented process. This includes evaluating the data and weighing the relevance of all equivalent devices.<\/p>\n<p><strong>Need help with writing a clinical evaluation report? Hire a freelance <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Medical Device CER writer<\/a> on Kolabtree. It&#8217;s free to post your project and get quotes.<\/strong><\/p>\n<p>Related Experts:<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Medical Device Consultants<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Freelance Medical Writer<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Freelance CER Writer<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">EU MDR Consultants<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">FDA Submissions<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Literature Search Experts<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Regulatory Compliance Experts<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Clinical Trials Expert<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">Regulatory Writers<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">PMS Consultants<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/country\/india\/subject\/post-market-clinical-followup?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">PMCF Consultants<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Biostatistics Experts<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=CERTips\">\u00a0Product Development Expert\u00a0<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sophie Laurenson, healthcare &amp; technology innovator\u00a0on Kolabtree, shares 5 tips for writing a clinical evaluation report and defining a CER strategy. The EU MDR has significantly impacted the way medical devices are regulated in Europe. As part of regulatory compliance, medical device manufacturers need to create and maintain a Clinical Evaluation Report (CER), a document<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/writing-a-clinical-evaluation-report-5-quick-tips\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":6882,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[247,443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Writing a Clinical Evaluation Report: 5 Quick Tips - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Writing a Clinical Evaluation Report: 5 Quick Tips\" \/>\n<meta property=\"og:description\" content=\"Quick tips on writing a clinical evaluation report (CER) for medical device compliance with the EU MDR.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/redaccion-de-un-informe-de-evaluacion-clinica-5-consejos-rapidos\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2020-02-07T13:14:07+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-04-06T12:36:40+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2020\/02\/writing-a-clinical-evaluation-report.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1280\" \/>\n\t<meta property=\"og:image:height\" content=\"853\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Ramya Sriram\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Ramya Sriram\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Writing a Clinical Evaluation Report: 5 Quick Tips - 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