{"id":20169,"date":"2022-02-24T14:43:15","date_gmt":"2022-02-24T13:43:15","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=20169"},"modified":"2022-02-24T14:43:15","modified_gmt":"2022-02-24T13:43:15","slug":"clinical-evidence-ivd-devices-mdcg-2022-2-guideline","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2022\/02\/24\/clinical-evidence-ivd-devices-mdcg-2022-2-guideline\/","title":{"rendered":"EUROPE: MDCG 2022-2 on clinical evidence for IVD devices published"},"content":{"rendered":"\n<p>The Medical\nDevice Coordination Group published the new guidance <strong>MDCG 2022-2 \u201cGuidance\non general principles of clinical evidence for In Vitro Diagnostic medical\ndevices (IVDs)\u201d<\/strong> on 27<sup>th<\/sup> January 2022.<\/p>\n\n\n\n<p>The paper outlines <strong>general principles of clinical evidence<\/strong> and gives information about the <strong>performance evaluation<\/strong> process for <strong>in Vitro Diagnostic-Medical Devices<\/strong> under the <strong>IVDR (EU) 2017\/746<\/strong> Regulation.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2022\/02\/europa-mdcg-2022-2-evidenza-clinica-dispositivi-ivd-1024x536.jpg\" alt=\"Europe MDCG 2022-2 on clinical evidence for IVD devices published\" class=\"wp-image-20113\"\/><figcaption>MDCG 2022-2 on clinical evidence for IVD devices published<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>General principles of clinical evidence<\/strong><\/h2>\n\n\n\n<p>Before placing an\nin Vitro Diagnostic-Medical Device on the market, the Manufacturer needs to\nplan, carry out, and document a <strong>performance evaluation<\/strong> to <strong>scientifically\nprove<\/strong> that the product is safe, and that it can achieve the clinical benefits\nexpected by the Manufacturer.<\/p>\n\n\n\n<p>In particular, during\nthe performance evaluation <strong>three principles<\/strong> that constitutes the <strong>clinical\nevidence<\/strong> are considered:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>Scientific validity,<\/strong> namely the association of an analyte physiological state or\nclinical condition.<\/li><li><strong>Analytical performances<\/strong> such as a device\u2019s ability to correctly detect or measure a\nparticular analyte.<\/li><li><strong>Clinical performance <\/strong>which is ability to yield results correlated with a particular\nclinical condition or a physiological\/pathological process or state in\naccordance with the target population and intended user.<\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Performance evaluation process<\/strong><\/h2>\n\n\n\n<p>Performance\nevaluation, run by the quality management system of the company, is a <strong>steady\nand ongoing process<\/strong> and needs to be performed during the entire life cycle\nof an in Vitro Diagnostic-Medical device. It has to be an objective evaluation,\nconsidering favourable and unfavourable data, risk\/benefit ratio, risk class,\nand the device\u2019s itself intended purpose.<\/p>\n\n\n\n<p>The general\nperformance evaluation principles are laid down in Article 56 and Annex XIII,\nPart A-1 of the IVDR (EU) 2017\/746 Regulation:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>Performance Evaluation <\/strong>Plan (PEP),<\/li><li><strong>Analysis, conclusions, and\ndocumentation<\/strong> (Performance Evaluation Report &#8211; PER),<\/li><li>Ongoing <strong>updating<\/strong> and <strong>monitoring<\/strong>\nthought Post-Market Performance Follow-up (PMPF).<\/li><\/ol>\n\n\n\n<p>In order to\nguarantee IVD\u2019s safety, it is important to constantly monitor scientific\ndevelopments and possible changes, as any relevant new information could\ntrigger re-evaluations of existing clinical evidence.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Clinical evidence and performance evaluation: how to deal with them?<\/strong><\/h2>\n\n\n\n<p><strong><a href=\"https:\/\/www.thema-med.com\/en\/services\/ce-certification-support\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"Thema is here to support you! (si apre in una nuova scheda)\">Thema is here to support you!<\/a><\/strong> If you are an IVDs Manufacturer, Thema\u2019s experts can assist and guide you step by step in clinical evidence and performance evaluation activities under the IVDR (EU) 2017\/746 Regulation.<\/p>\n\n\n\n<p><strong><a href=\"mailto:sales@thema-med.com\">For further information and for a proposal contact us!<\/a><\/strong><\/p>\n\n\n\n<p><em>Source:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/system\/files\/2022-01\/mdcg_2022-2_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">MDCG 2022-2 \u201cGuidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs)\u201d. MDCG, january 2022<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Medical Device Coordination Group published the new guidance MDCG 2022-2 \u201cGuidance on general principles of clinical evidence for In Vitro  [&#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-20169","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>Clinical evidence IVD devices: MDCG 2022-2 guideline published<\/title>\n<meta name=\"description\" content=\"Clinical evidence iVD 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