{"id":6459,"date":"2019-11-18T03:26:48","date_gmt":"2019-11-18T03:26:48","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6459"},"modified":"2020-10-30T17:27:47","modified_gmt":"2020-10-30T17:27:47","slug":"what-is-a-clinical-evaluation-report","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/","title":{"rendered":"Qu'est-ce qu'un rapport d'\u00e9valuation clinique ?"},"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 des mati\u00e8res<\/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-69f2f141760a2\" aria-label=\"Table des mati\u00e8res\"><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-69f2f141760a2\"><\/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\/fr\/what-is-a-clinical-evaluation-report\/#EU_MDR_and_CE_Marking\" title=\"MDR de l&#039;UE et marquage CE\">MDR de l'UE et marquage CE<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/#Clinical_Evaluation_Report\" title=\"Rapport d&#039;\u00e9valuation clinique\">Rapport d'\u00e9valuation clinique<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/#Equivalence\" title=\"\u00c9quivalence\">\u00c9quivalence<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/#Literature_Review\" title=\"Revue de la litt\u00e9rature \">Revue de la litt\u00e9rature <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/#How_long_does_it_take_to_write_a_CER\" title=\"Combien de temps faut-il pour r\u00e9diger un CER ?\u00a0\">Combien de temps faut-il pour r\u00e9diger un CER ?\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/#Clinical_Evaluation_Report_Writers\" title=\"R\u00e9dacteurs de rapports d&#039;\u00e9valuation clinique\">R\u00e9dacteurs de rapports d'\u00e9valuation clinique<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/#How_to_hire_a_freelance_CER_writer\" title=\"Comment engager un r\u00e9dacteur CER ind\u00e9pendant\u00a0\">Comment engager un r\u00e9dacteur CER ind\u00e9pendant\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p>A <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatisCER\">rapport d'\u00e9valuation clinique (CER)<\/a> is a technical document required by <a href=\"https:\/\/www.kolabtree.com\/blog\/fr\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">dispositif m\u00e9dical<\/a> companies that want to sell or distribute products in Europe. The CER provides a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"EU_MDR_and_CE_Marking\"><\/span>MDR de l'UE et marquage CE<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>En Europe, les dispositifs m\u00e9dicaux doivent obtenir une \"marque CE\", qui indique que le produit est conforme aux r\u00e9glementations de l'UE (MDD, MDR ou IVDR, selon le cas). La r\u00e9cente r\u00e9glementation sur les dispositifs m\u00e9dicaux en Europe a eu un impact significatif sur la mani\u00e8re dont les dispositifs m\u00e9dicaux sont r\u00e9glement\u00e9s et approuv\u00e9s dans l'UE. Le MDR est le plus grand changement apport\u00e9 \u00e0 la l\u00e9gislation sur les dispositifs m\u00e9dicaux depuis plus de 20 ans. Parmi les principaux changements apport\u00e9s par le MDR (par rapport au MDD) figurent la classification des dispositifs, la documentation des dossiers techniques, la tra\u00e7abilit\u00e9 et la surveillance post-commercialisation.<\/p>\n<p><strong>Lire la suite : <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-get-a-ce-mark-for-your-medical-device-eu-mdr\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Conseils pour obtenir un marquage CE pour votre dispositif m\u00e9dical<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Report\"><\/span>Rapport d'\u00e9valuation clinique<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Le RIM accorde une grande importance aux rapports d'\u00e9valuation clinique ou CER. Le CER fait partie du dossier technique, qui est la principale documentation d\u00e9montrant la conformit\u00e9 r\u00e9glementaire et fournissant toutes les informations sur le dispositif. Les entreprises de dispositifs m\u00e9dicaux doivent prendre plusieurs mesures pour s'assurer que leur CER est bien pr\u00e9par\u00e9 et bien tenu \u00e0 jour. La documentation CER comprend g\u00e9n\u00e9ralement 4 \u00e9tapes :<\/p>\n<ul>\n<li>D\u00e9finir le champ d'application du dispositif, son utilisation pr\u00e9vue et les all\u00e9gations th\u00e9rapeutiques\/diagnostiques.<\/li>\n<li>Identifier et valider les donn\u00e9es cliniques<\/li>\n<li>Analyser les donn\u00e9es et les interpr\u00e9ter pour voir si elles r\u00e9pondent \u00e0 toutes les exigences.<\/li>\n<li>Identifier les risques et les incertitudes, auxquels il est possible de r\u00e9pondre au cours de la surveillance post-commercialisation (PMS).<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Une CER doit \u00eatre r\u00e9guli\u00e8rement mise \u00e0 jour tout au long du cycle de vie d'un dispositif m\u00e9dical. <\/span><span style=\"font-weight: 400;\">Le document doit contenir les preuves cliniques qui \u00e9tayent la preuve de la conformit\u00e9 aux Exigences Essentielles (ERs) du MEDDEV 2.7\/1 Rev. 4 Annexe 1 (Exigences de s\u00e9curit\u00e9 et de performance dans le MDR). Le document doit \u00e9galement d\u00e9crire les aspects physiques et techniques et la composition du dispositif, ainsi que les instructions d'utilisation.\u00a0<\/span><\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone wp-image-6464 size-full\" src=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report.jpg\" alt=\"\" width=\"904\" height=\"718\" srcset=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report.jpg 904w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report-300x238.jpg 300w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report-768x610.jpg 768w, https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2019\/11\/clinical-evaluation-report-300x238@2x.jpg 600w\" sizes=\"(max-width: 904px) 100vw, 904px\" \/><\/p>\n<p><em>Les quatre \u00e9tapes de la RCE, telles que d\u00e9crites dans <span style=\"font-weight: 400;\"><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/17522\/attachments\/1\/translations\/en\/renditions\/native\">MEDDEV 2.7\/ rev. 4<\/a>.\u00a0<\/span><\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Equivalence\"><\/span>\u00c9quivalence<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Les fabricants de dispositifs m\u00e9dicaux doivent \u00e9valuer les donn\u00e9es cliniques de leur propre dispositif m\u00e9dical ou d'un dispositif \u00e9quivalent, dont la s\u00e9curit\u00e9 et les performances cliniques ne sont pas diff\u00e9rentes. En vertu du RIM, le fabricant de dispositifs m\u00e9dicaux doit tenir compte de trois facteurs pour prouver qu'un produit est \u00e9quivalent : biologique, technique et clinique.<\/p>\n<p><strong>\u00c9quivalence technique<\/strong> signifie que le dispositif doit avoir les m\u00eames sp\u00e9cifications de conception et de composition, et doit \u00eatre utilis\u00e9 dans les m\u00eames conditions, avec la m\u00eame m\u00e9thode de d\u00e9ploiement et les m\u00eames principes op\u00e9rationnels. <strong>\u00c9quivalence clinique<\/strong> signifie que le dispositif doit \u00eatre utilis\u00e9 pour traiter la m\u00eame affection, au m\u00eame endroit du corps et pour le m\u00eame groupe de population, en obtenant des performances similaires.<br \/>\n<strong>\u00c9quivalence biologique<\/strong> signifie que le dispositif m\u00e9dical en question ne doit pas entra\u00eener de risque biologique.<\/p>\n<p>Si un dispositif m\u00e9dical n'est pas en mesure de d\u00e9montrer l'\u00e9quivalence, il doit soit effectuer des recherches cliniques suppl\u00e9mentaires, soit retirer l'all\u00e9gation de son produit.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_Review\"><\/span>Revue de la litt\u00e9rature <b><\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Les r\u00e9sultats de la recherche documentaire constituent une partie essentielle du rapport d'\u00e9valuation clinique. Un processus solide d'examen de la documentation doit \u00eatre mis en place afin que toute la documentation publi\u00e9e relative au dispositif soit facilement accessible et puisse soutenir l'all\u00e9gation faite. Les revues de la litt\u00e9rature n\u00e9cessitent g\u00e9n\u00e9ralement l'expertise d'un chercheur qualifi\u00e9 qui peut identifier le terme de recherche correct, utiliser des bases de donn\u00e9es comme PubMED ou MEDLine, trouver la litt\u00e9rature pertinente et l'\u00e9valuer, y compris en utilisant les r\u00e9f\u00e9rences pertinentes. L'analyse documentaire doit \u00e9galement aborder toutes les questions auxquelles les donn\u00e9es cliniques ne peuvent r\u00e9pondre.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_long_does_it_take_to_write_a_CER\"><\/span><b>Combien de temps faut-il pour r\u00e9diger un CER ?\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">L'identification et la collecte de toutes les donn\u00e9es qui entrent dans la CER et la pr\u00e9paration du document conform\u00e9ment aux directives peuvent prendre plusieurs semaines ou mois. La surveillance post-commercialisation (PMS) constitue une part importante du processus, m\u00eame apr\u00e8s la certification du marquage CE, et la PMS doit \u00eatre un \u00e9l\u00e9ment central du syst\u00e8me de gestion de la qualit\u00e9 (QMS) du fabricant. Dans certains cas, un suivi clinique post-commercialisation (PMCF) est \u00e9galement requis, ce qui implique la collecte proactive de donn\u00e9es cliniques et leur \u00e9valuation pour r\u00e9pondre aux exigences de s\u00e9curit\u00e9 et de performance.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">La CER n'est pas un document statique. Il est recommand\u00e9 aux fabricants de dispositifs m\u00e9dicaux d'\u00e9laborer un processus et une strat\u00e9gie solides int\u00e9grant les bonnes pratiques pour les aider \u00e0 conserver l'acc\u00e8s au march\u00e9 de l'UE, \u00e0 \u00e9viter tout rappel de produits et \u00e0 rationaliser le temps et les ressources consacr\u00e9s \u00e0 la tenue du document.\u00a0<\/span><\/p>\n<p>Confier la r\u00e9daction de CER \u00e0 un expert ind\u00e9pendant peut vous faire gagner un temps et une \u00e9nergie pr\u00e9cieux. <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\">R\u00e9dacteurs ind\u00e9pendants de rapports d'\u00e9valuation clinique<\/a> sont en mesure de d\u00e9velopper des CER \u00e0 partir de 3 000 USD sur Kolabtree.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Report_Writers\"><\/span>R\u00e9dacteurs de rapports d'\u00e9valuation clinique<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Le temps et l'expertise n\u00e9cessaires \u00e0 l'\u00e9laboration d'une RCE peuvent mettre \u00e0 rude \u00e9preuve les ressources de plusieurs start-ups ou PME du secteur des dispositifs m\u00e9dicaux, qui ne disposent pas n\u00e9cessairement de sp\u00e9cialistes en interne. La collaboration avec des experts externes, notamment des r\u00e9dacteurs de RCE ind\u00e9pendants, des analystes de donn\u00e9es cliniques, des experts en analyse documentaire, des biostatisticiens et des r\u00e9dacteurs m\u00e9dicaux, peut aider les entreprises \u00e0 s'assurer que leur strat\u00e9gie de RCE est solide et que leurs donn\u00e9es sont toutes v\u00e9rifi\u00e9es et exactes.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_hire_a_freelance_CER_writer\"><\/span><b>Comment engager un r\u00e9dacteur CER ind\u00e9pendant\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Les comp\u00e9tences \u00e0 rechercher chez un r\u00e9dacteur de CER comprennent une exp\u00e9rience des r\u00e9glementations et des processus d'approbation des dispositifs m\u00e9dicaux, une bonne connaissance de MEDDEV 2.7\/ rev. 4, la connaissance des domaines th\u00e9rapeutiques et de solides comp\u00e9tences analytiques. <strong>L'\u00e9quipe mondiale d'experts de Kolabtree comprend des personnes qualifi\u00e9es dans les domaines suivants <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">R\u00e9dacteurs de rapports d'\u00e9valuation clinique<\/a>qui peuvent vous aider \u00e0 \u00e9tablir un rapport d'\u00e9valuation exhaustif et bien document\u00e9. Il est gratuit de publier votre projet et d'obtenir des devis d'experts.\u00a0 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Commencez<\/a><\/strong><\/span><\/p>\n<p>Experts connexes :<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Consultants en dispositifs m\u00e9dicaux<\/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=WhatIsCER\">R\u00e9dacteur m\u00e9dical ind\u00e9pendant<\/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=WhatIsCER\">R\u00e9dacteur ind\u00e9pendant du CER<\/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=WhatIsCER\">Consultants MDR de l'UE<\/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=WhatIsCER\">Soumissions \u00e0 la FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Experts en recherche documentaire<\/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=WhatIsCER\">Experts en conformit\u00e9 r\u00e9glementaire<\/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=WhatIsCER\">Expert en essais cliniques<\/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=WhatIsCER\">R\u00e9dacteurs de textes r\u00e9glementaires<\/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=WhatIsCER\">Consultants PMS<\/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=WhatIsCER\">Consultants du PMCF<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">\u00a0Experts en biostatistique<\/a>\u00a0|<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">\u00a0Expert en d\u00e9veloppement de produits\u00a0<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>A clinical evaluation report (CER) is a technical document required by medical device companies that want to sell or distribute products in Europe. The CER provides a comprehensive overview of the medical device design and composition, intended usage and applications, clinical trials analysis and outcomes, relevant literature reviews, protocols and instructions for use. EU MDR<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/fr\/what-is-a-clinical-evaluation-report\/\" title=\"Lire la suite\">Lire la suite<\/a><\/div>","protected":false},"author":12,"featured_media":6465,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540,147],"tags":[498,499,500],"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>What is a Clinical Evaluation Report? - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"A clinical evaluation report (CER) is a document required by all medical devices that want to sell in Europe. 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