{"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\/pt\/what-is-a-clinical-evaluation-report\/","title":{"rendered":"O que \u00e9 um Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica?"},"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\">Tabela de Conte\u00fados<\/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-69f2f16aa04ba\" 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-69f2f16aa04ba\"><\/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\/pt\/what-is-a-clinical-evaluation-report\/#EU_MDR_and_CE_Marking\" title=\"Marca\u00e7\u00e3o UE MDR e CE\">Marca\u00e7\u00e3o UE MDR e CE<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-is-a-clinical-evaluation-report\/#Clinical_Evaluation_Report\" title=\"Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica\">Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-is-a-clinical-evaluation-report\/#Equivalence\" title=\"Equival\u00eancia\">Equival\u00eancia<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-is-a-clinical-evaluation-report\/#Literature_Review\" title=\"Revis\u00e3o da Literatura \">Revis\u00e3o da Literatura <\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-is-a-clinical-evaluation-report\/#How_long_does_it_take_to_write_a_CER\" title=\"Quanto tempo leva para escrever um CER?\u00a0\">Quanto tempo leva para escrever um 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\/pt\/what-is-a-clinical-evaluation-report\/#Clinical_Evaluation_Report_Writers\" title=\"Redatores de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica\">Redatores de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-is-a-clinical-evaluation-report\/#How_to_hire_a_freelance_CER_writer\" title=\"Como contratar um redator freelancer CER\u00a0\">Como contratar um redator freelancer CER\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\">relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica (CER)<\/a> is a technical document required by <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">dispositivo m\u00e9dico<\/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>Marca\u00e7\u00e3o UE MDR e CE<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Os dispositivos m\u00e9dicos na Europa precisam obter uma \"Marca CE\", que indica que o produto est\u00e1 em conformidade com os regulamentos da UE (MDD, MDR ou IVDR, o que for aplic\u00e1vel). As recentes Regulamenta\u00e7\u00f5es de Produtos m\u00e9dicos na Europa tiveram um impacto significativo na forma como os dispositivos m\u00e9dicos s\u00e3o regulamentados e aprovados na UE. O MDR \u00e9 a maior mudan\u00e7a na legisla\u00e7\u00e3o de produtos m\u00e9dicos em mais de 20 anos. Algumas grandes mudan\u00e7as na MDR (em compara\u00e7\u00e3o com a MDD) incluem classifica\u00e7\u00e3o de dispositivos, documenta\u00e7\u00e3o de arquivo t\u00e9cnico, rastreabilidade e vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.<\/p>\n<p><strong>Leia mais: <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\">As melhores dicas para obter a marca CE para seu dispositivo m\u00e9dico<\/a><\/strong><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Report\"><\/span>Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>O MDR coloca grande \u00eanfase nos Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica ou CERs. O RCE faz parte do Arquivo T\u00e9cnico, que \u00e9 a principal documenta\u00e7\u00e3o que demonstra a conformidade regulamentar e fornece todas as informa\u00e7\u00f5es sobre o dispositivo. As empresas de dispositivos m\u00e9dicos precisam tomar v\u00e1rias medidas para garantir que suas RCEs estejam bem preparadas e bem mantidas. A documenta\u00e7\u00e3o do CER normalmente compreende 4 etapas:<\/p>\n<ul>\n<li>Definir o escopo do dispositivo, seu uso pretendido e suas reivindica\u00e7\u00f5es terap\u00eauticas\/diagn\u00f3sticas<\/li>\n<li>Identifica\u00e7\u00e3o e valida\u00e7\u00e3o de dados cl\u00ednicos<\/li>\n<li>Analisar os dados e interpret\u00e1-los para ver se atendem a todos os requisitos<\/li>\n<li>Identifica\u00e7\u00e3o de riscos e incertezas, que podem ser respondidos durante a vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o (PMS)<\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Um CER precisa ser atualizado regularmente ao longo de todo o ciclo de vida de um dispositivo m\u00e9dico. <\/span><span style=\"font-weight: 400;\">O documento deve conter as provas cl\u00ednicas que suportam a prova de conformidade com os Requisitos Essenciais (RE) no MEDDEV 2.7\/1 Rev. 4 Anexo 1 (Requisitos de Seguran\u00e7a e Desempenho no MDR). O documento tamb\u00e9m deve descrever os aspectos f\u00edsicos e t\u00e9cnicos e a composi\u00e7\u00e3o do dispositivo, juntamente com as instru\u00e7\u00f5es de uso.\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>As quatro etapas do CER, conforme descritas em <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>Equival\u00eancia<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Os fabricantes de dispositivos m\u00e9dicos precisam avaliar os dados cl\u00ednicos de seu pr\u00f3prio dispositivo m\u00e9dico ou de um dispositivo equivalente, cuja seguran\u00e7a e desempenho cl\u00ednico n\u00e3o sejam diferentes. Sob o MDR, o fabricante de dispositivos m\u00e9dicos tem que considerar tr\u00eas fatores para provar que um produto \u00e9 equivalente: biol\u00f3gico, t\u00e9cnico e cl\u00ednico.<\/p>\n<p><strong>Equival\u00eancia t\u00e9cnica<\/strong> significa que o dispositivo deve ter as mesmas especifica\u00e7\u00f5es de projeto e composi\u00e7\u00e3o, e deve ser utilizado nas mesmas condi\u00e7\u00f5es, com o mesmo m\u00e9todo de implanta\u00e7\u00e3o e princ\u00edpios operacionais. <strong>Equival\u00eancia cl\u00ednica<\/strong> significa que o dispositivo deve ser usado para tratar a mesma condi\u00e7\u00e3o, no mesmo local do corpo e para o mesmo grupo de popula\u00e7\u00e3o, alcan\u00e7ando desempenho semelhante.<br \/>\n<strong>Equival\u00eancia Biol\u00f3gica<\/strong> significa que o dispositivo m\u00e9dico em quest\u00e3o n\u00e3o deve causar qualquer risco biol\u00f3gico.<\/p>\n<p>Se um dispositivo m\u00e9dico for incapaz de demonstrar equival\u00eancia, eles t\u00eam que realizar uma investiga\u00e7\u00e3o cl\u00ednica adicional ou remover a reivindica\u00e7\u00e3o de seu produto.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Literature_Review\"><\/span>Revis\u00e3o da Literatura <b><\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Um forte processo de revis\u00e3o de literatura precisa ser estabelecido para que toda a literatura publicada relevante para o dispositivo seja facilmente acess\u00edvel e possa apoiar a alega\u00e7\u00e3o que est\u00e1 sendo feita. As revis\u00f5es de literatura normalmente precisam da experi\u00eancia de um pesquisador especializado que possa identificar o termo de pesquisa correto, usar bancos de dados como PubMED ou MEDLine, encontrar literatura relevante e avali\u00e1-la, inclusive usando refer\u00eancias relevantes. A revis\u00e3o da literatura tamb\u00e9m deve abordar quaisquer quest\u00f5es que os dados cl\u00ednicos n\u00e3o sejam capazes de responder.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_long_does_it_take_to_write_a_CER\"><\/span><b>Quanto tempo leva para escrever um CER?\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Identificar e reunir todos os dados que entram no CER e preparar o documento de acordo com as diretrizes pode levar v\u00e1rias semanas ou meses. A vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o (PMS) constitui uma grande parte do processo mesmo ap\u00f3s a certifica\u00e7\u00e3o da marca CE, e o PMS tem que ser uma parte central do Sistema de Gest\u00e3o de Qualidade (QMS) dos fabricantes. Alguns casos tamb\u00e9m requerem Acompanhamento Cl\u00ednico P\u00f3s-Mercado (PMCF) que envolve a coleta proativa de dados cl\u00ednicos e sua avalia\u00e7\u00e3o para atender \u00e0s exig\u00eancias de seguran\u00e7a e desempenho.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O CER n\u00e3o \u00e9 um documento est\u00e1tico. \u00c9 recomendado que os fabricantes de dispositivos m\u00e9dicos desenvolvam um processo robusto e uma estrat\u00e9gia incorporando boas pr\u00e1ticas para ajud\u00e1-los a manter o acesso ao mercado na UE, evitar qualquer recall de produtos e agilizar o tempo e os recursos usados para manter o documento.\u00a0<\/span><\/p>\n<p>A terceiriza\u00e7\u00e3o da escrita do CER para um especialista freelance pode ajudar a economizar tempo e energia preciosos. <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\">Autores de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica freelance<\/a> s\u00e3o capazes de desenvolver RCEs a partir de USD 3.000 em Kolabtree.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Clinical_Evaluation_Report_Writers\"><\/span>Redatores de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>O tempo e a experi\u00eancia necess\u00e1rios para montar um CER pode ser uma tens\u00e3o de recursos para v\u00e1rias startups de dispositivos m\u00e9dicos ou SMBs de dispositivos m\u00e9dicos, que podem n\u00e3o ter especialistas internos. Trabalhando com especialistas externos, incluindo escritores freelance CER, analistas de dados cl\u00ednicos, bioestat\u00edsticos especialistas em revis\u00e3o de literatura e escritores m\u00e9dicos podem ajudar as empresas a garantir que sua estrat\u00e9gia de CER seja robusta e que seus dados sejam todos verificados e precisos.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_to_hire_a_freelance_CER_writer\"><\/span><b>Como contratar um redator freelancer CER\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">As habilidades a serem procuradas em um redator CER incluem experi\u00eancia em lidar com regulamentos e processos de aprova\u00e7\u00e3o de dispositivos m\u00e9dicos, familiaridade com a MEDDEV 2.7\/ rev. 4, conhecimento de \u00e1reas terap\u00eauticas e forte capacidade anal\u00edtica. <strong>O pool global de especialistas da Kolabtree inclui especialistas qualificados <a href=\"https:\/\/www.kolabtree.com\/services\/clinical-evaluation-report-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Redatores de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica<\/a>que pode ajud\u00e1-lo a montar um CER bem pesquisado e minucioso. \u00c9 livre para publicar seu projeto e obter cita\u00e7\u00f5es de especialistas.\u00a0 <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Comece<\/a><\/strong><\/span><\/p>\n<p>Peritos relacionados:<\/p>\n<p><strong><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Consultores de Produtos m\u00e9dicos<\/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\">Escritor M\u00e9dico Freelancer<\/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\">Escritor aut\u00f4nomo do 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\">Consultores MDR da 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\">Envios da FDA<\/a>\u00a0|\u00a0<a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=WhatIsCER\">Especialistas em Pesquisa de Literatura<\/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\">Peritos em Conformidade Regulat\u00f3ria<\/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\">Especialista em ensaios cl\u00ednicos<\/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\">Escritores Reguladores<\/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\">Consultores 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\">Consultores da 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\">\u00a0Especialistas em Bioestat\u00edstica<\/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\">\u00a0Especialista em desenvolvimento de produtos\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\/pt\/what-is-a-clinical-evaluation-report\/\" title=\"Leia mais\">Leia mais<\/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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