{"id":15175,"date":"2020-08-05T15:54:34","date_gmt":"2020-08-05T13:54:34","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15175"},"modified":"2020-08-05T15:54:34","modified_gmt":"2020-08-05T13:54:34","slug":"eu-mdcg-2020-13-verification-clinical-product-evaluation","status":"publish","type":"post","link":"http:\/\/www.thema-med.com\/en\/2020\/08\/05\/eu-mdcg-2020-13-verification-clinical-product-evaluation\/","title":{"rendered":"EUROPE: the MDCG 2020-13 for the verification of the clinical product evaluation has been published"},"content":{"rendered":"\n<p>The European Commission has published the<strong> <\/strong>guideline<strong> MDCG<\/strong> <strong>2020-13 : \u201cClinical evaluation assessment report template (CEAR)\u201d<\/strong>. <\/p>\n\n\n\n<p>This is a <strong>clinical evaluation report used by Notified\nBodies<\/strong> (not for Manufacturers) which explains in detail whether and how the\nrelevant technical documentation of the medical device Manufacturer meets the needed\nrequirements.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/08\/eu-nuovo-documento-mdcg-2020-13-1024x536.png\" alt=\"The MDCG 2020-13 for the verification of the clinical product evaluation has been published \" class=\"wp-image-15145\"\/><figcaption>The MDCG 2020-13 for the verification of the clinical product evaluation <br>has been published <\/figcaption><\/figure>\n\n\n\n<p>This\ndocument is therefore an excellent indirect tool for Manufacturers to\nunderstand whether and how the outputs of the clinical product evaluation\nprocess comply with MDR requirements.<\/p>\n\n\n\n<p>Clinical\nevaluation is a challenging and fundamental process included in the <strong>MDR Medical Devices Regulation (EU) 2017\/745<\/strong>\nand, as part of the <strong>Quality Management\nSystem<\/strong>, must be aligned and consistent with other system processes, such\nas:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>risk management<\/strong>, throughout the lifecycle of the device;<\/li><li><strong>post-market surveillance<\/strong>, including any eventual security corrective action that involves the device;<\/li><li><strong>clinical post-market follow-up<\/strong>;<\/li><li><strong>labelling<\/strong>, in order to provide adequate information on the intended purpose.<\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>What is the purpose of the new MDCG 2020-13 document?<\/strong><\/h2>\n\n\n\n<p>The\npurpose is to provide a <strong>CEAR report<\/strong>\ntemplate to <strong>document the clinical\nevaluation process<\/strong>. This template can be applied to Annexes IX section 4\nand X section 3 of MDR (EU) 2017\/745. <\/p>\n\n\n\n<p>In\naddition, it can be used for the assessment of sample-based documentation for\nClass IIa \/ IIb devices in accordance with Sections 2.3 and 3.5 of Annex IX and\nSection 10 of Annex XI (A). <\/p>\n\n\n\n<p>Finally,\nit also applies to medical devices for which clinical data are not considered\nappropriate.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>CEAR Report: Instructions for use<\/strong><\/h2>\n\n\n\n<p>The MDCG\n2020-13 document provides information on how the Notified Body should complete\nthe CEAR report. <\/p>\n\n\n\n<p><strong>The CEAR report documents the outcome and conclusions of the\nclinical evaluation<\/strong>.<\/p>\n\n\n\n<p style=\"background-color:#0099a8;color:#ffffff\" class=\"has-text-color has-background\">Thema offers <strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/strategic-regulatory-consulting-2\/\">strategic-regulatory consulting<\/a><\/strong> services to companies that manufacture or distribute Medical Devices (DM) and &#8211; In Vitro Diagnostic Medical Devices IVD.<br><strong>If you want to know how we can help you, please <\/strong><a href=\"mailto:sales@thema-group.it\"><strong>contact us<\/strong><\/a><strong>!<\/strong><\/p>\n\n\n\n<p><em>Source: <\/em> <br><br><a href=\"https:\/\/bit.ly\/3fbCRoU\">https:\/\/bit.ly\/3fbCRoU<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Commission has published the guideline MDCG 2020-13 : \u201cClinical evaluation assessment report template (CEAR)\u201d. This is a clinical evaluation  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-15175","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EU: MDCG 2020-13 for verification of the clinical product evaluation<\/title>\n<meta name=\"description\" content=\"The European Commission has published the MDCG 2020-13 guideline for verification of clinical product evaluation. 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