{"id":6859,"date":"2020-02-07T11:52:11","date_gmt":"2020-02-07T11:52:11","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=6859"},"modified":"2020-11-10T11:05:35","modified_gmt":"2020-11-10T11:05:35","slug":"medical-device-eu-mdr-compliance-challenges-and-resource-crunch","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/","title":{"rendered":"Conformidade MDR da UE para Dispositivos M\u00e9dicos: Desafios e crise de recursos"},"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-69f2f140ceb8f\" 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-69f2f140ceb8f\"><\/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\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/#EU_MDR_Resource_Crunch\" title=\"EU MDR: Crunch de recursos\">EU MDR: Crunch de recursos<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/#Barriers_to_EU_MDR_compliance\" title=\"Obst\u00e1culos ao cumprimento da RDM da UE\">Obst\u00e1culos ao cumprimento da RDM da UE<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/#Working_with_MDR_consultants\" title=\"Trabalhando com consultores MDR\u00a0\">Trabalhando com consultores MDR\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\"><em>Este artigo delineia os desafios <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">dispositivo m\u00e9dico<\/a> os fabricantes est\u00e3o enfrentando com <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Conformidade com a RDM da UE<\/a> e a disponibilidade de <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">escritores freelance CER<\/a> e <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Consultores MDR<\/a> como uma solu\u00e7\u00e3o.\u00a0<\/em><\/span><\/p>\n<blockquote><p><strong>Atualiza\u00e7\u00e3o 13 de maio de 2020: O MDR da UE \u00e9 agora adiado para 26 de maio de 2021, \u00e0 luz da COVID-19. Isto d\u00e1 <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> empresas mais tempo para se preparar para isso. Este artigo ser\u00e1 atualizado \u00e0 medida que tivermos mais dados.\u00a0<\/strong><\/p><\/blockquote>\n<p>O MDR da UE \u00e9 um novo regulamento de dispositivos m\u00e9dicos que afeta todos os dispositivos m\u00e9dicos colocados no mercado europeu. Ela foi introduzida em 2017 para substituir a Diretiva de Dispositivos M\u00e9dicos (MDD) existente. Qualquer empresa de produtos m\u00e9dicos que queira vender seus produtos no mercado deve agora cumprir com a MDR 2017\/745 para obter a marca CE. Os fabricantes de produtos m\u00e9dicos existentes que j\u00e1 est\u00e3o no mercado devem atualizar sua documenta\u00e7\u00e3o t\u00e9cnica e seus processos de acordo com a nova regulamenta\u00e7\u00e3o, cujo prazo final \u00e9 26 de maio de 2020.<\/p>\n<p><span style=\"font-weight: 400;\">Qualquer dispositivo m\u00e9dico que \u00e9 vendido na regi\u00e3o da UE precisa ter uma marca CE. A UE designou Organismos Notificados que est\u00e3o autorizados a certificar os fabricantes de produtos m\u00e9dicos. Com o objetivo geral de melhorar a seguran\u00e7a e o desempenho, o novo regulamento inclui mudan\u00e7as na documenta\u00e7\u00e3o do arquivo t\u00e9cnico, reivindicando equival\u00eancia, avalia\u00e7\u00e3o cl\u00ednica, classifica\u00e7\u00e3o do dispositivo e vigil\u00e2ncia p\u00f3s-comercializa\u00e7\u00e3o.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"EU_MDR_Resource_Crunch\"><\/span>EU MDR: Crunch de recursos<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Mesmo que o prazo esteja a apenas alguns meses, h\u00e1 incerteza entre os profissionais reguladores e as empresas de dispositivos m\u00e9dicos sobre o que isso realmente significa. H\u00e1 uma grande escassez de recursos na ind\u00fastria de profissionais que podem compreender e implementar a conformidade regulat\u00f3ria MDR.<\/p>\n<blockquote><p>Para colocar as coisas em perspectiva:\u00a0<span style=\"font-weight: 400;\">Existem cerca de 27.000 empresas de tecnologia m\u00e9dica na Europa, <\/span><a href=\"https:\/\/mapmedtech.com\/2019\/06\/medtech-europe-publish-the-european-medical-technology-industry-in-figures-2019\/\"><span style=\"font-weight: 400;\">dos quais 95%<\/span><\/a><span style=\"font-weight: 400;\"> s\u00e3o pequenas e m\u00e9dias empresas (PMEs). Muitas dessas empresas podem n\u00e3o ter recursos internos para acompanhar as exig\u00eancias do MDR. Se n\u00e3o cumprirem, correm o risco de que seu produto seja totalmente retirado do mercado da UE.\u00a0<\/span><\/p><\/blockquote>\n<p><span style=\"font-weight: 400;\">Uma das raz\u00f5es para o r\u00e1pido crescimento das PMEs na ind\u00fastria de dispositivos m\u00e9dicos \u00e9 tamb\u00e9m a taxa de inova\u00e7\u00e3o. Entre 2007 e 2017, o n\u00famero de pedidos de patente europeus para tecnologia m\u00e9dica aumentou em cerca de 50%.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Barriers_to_EU_MDR_compliance\"><\/span>Obst\u00e1culos ao cumprimento da RDM da UE<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>O MDR da UE \u00e9 uma das maiores mudan\u00e7as nos regulamentos de dispositivos m\u00e9dicos em mais de 20 anos. V\u00e1rias empresas de produtos m\u00e9dicos est\u00e3o encontrando falta de recursos e experi\u00eancia para atender \u00e0s novas exig\u00eancias. Alguns dos desafios que as empresas est\u00e3o enfrentando incluem:<\/p>\n<p><strong>Falta de clareza nos regulamentos<\/strong><br \/>\n<span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\">Uma pesquisa recente realizada pela RAPS\/KPMG mostra que mais de 78% de empresas de dispositivos m\u00e9dicos n\u00e3o entendem completamente a MDR da UE. As mudan\u00e7as s\u00e3o extensas e exigem que as organiza\u00e7\u00f5es desenvolvam um plano abrangente para se prepararem para a implementa\u00e7\u00e3o completa do MDR. Muitas das mudan\u00e7as afetam v\u00e1rias fun\u00e7\u00f5es n\u00e3o apenas dentro de uma organiza\u00e7\u00e3o, mas tamb\u00e9m com seus parceiros comerciais e \u00d3rg\u00e3os Notificados. <\/span><\/span><\/p>\n<blockquote><p><span style=\"font-weight: 400;\"><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Redator de relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica freelance<\/a> Basak Erpolat diz,<\/span><\/span><br \/>\n\u201cM<span style=\"font-weight: 400;\">Os fabricantes de dispositivos m\u00e9dicos ainda n\u00e3o entendem as exig\u00eancias da MDR e a seriedade da linha do tempo. O documento com o qual todos est\u00e3o lutando parece ser CERs e a exig\u00eancia de 'evid\u00eancia cl\u00ednica suficiente'\". Erpolat tamb\u00e9m enfatiza que se tornou muito mais dif\u00edcil para os dispositivos m\u00e9dicos reivindicar equival\u00eancia - o que apresenta uma crise para os fabricantes que n\u00e3o t\u00eam dados cl\u00ednicos suficientes para dispositivos de baixo risco.<\/span><\/p><\/blockquote>\n<p><strong>Falta de acesso a profissionais qualificados\u00a0<\/strong><br \/>\nO conjunto de profissionais especializados que podem ajudar na implementa\u00e7\u00e3o do MDR \u00e9 significativamente menor do que<br \/>\no conjunto de fabricantes de dispositivos m\u00e9dicos que precisam deles. O acesso a profissionais qualificados \u00e9 um dos maiores desafios que as PMEs de produtos m\u00e9dicos enfrentam. A Kolabtree tem visto um aumento no n\u00famero de projetos que procuram escritores aut\u00f4nomos de CER para v\u00e1rias classes de dispositivos m\u00e9dicos, incluindo dispositivos de alto risco. Embora as empresas estabelecidas possam ter acesso a equipes internas de especialistas, as PMEs est\u00e3o procurando trabalhar com consultores sob demanda.<\/p>\n<p><strong>Atraso na designa\u00e7\u00e3o dos Organismos Notificados\u00a0<\/strong><br \/>\nMuitos existentes <a href=\"https:\/\/www.medtechdive.com\/news\/disruption-eu-mdr-notified-bodies-shortage-dive-awards\/564884\/\">Os organismos notificados est\u00e3o sobrecarregados<\/a> e est\u00e3o lutando para acompanhar a carga de trabalho. Tamb\u00e9m houve um atraso nas NBs designadas, o que tornou o per\u00edodo de espera ainda mais longo para os fabricantes. <span style=\"font-weight: 400;\">A partir de janeiro de 2020, apenas 9 dos 55 Organismos Notificados foram aprovados para a certifica\u00e7\u00e3o MDR.\u00a0<\/span><span style=\"font-weight: 400;\">A pesquisa RAPS\/KPMG tamb\u00e9m relatou que 35% das organiza\u00e7\u00f5es sentiram que a falta de Organismos Notificados era uma barreira \u00e0 conformidade.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Dado o tempo e o custo de investimento envolvidos no cumprimento das exig\u00eancias do MDR, os fabricantes est\u00e3o come\u00e7ando a olhar tamb\u00e9m para mercados alternativos como a China e a Cor\u00e9ia, onde podem lan\u00e7ar seus produtos f\u00e1cil e rapidamente. <\/span><span style=\"font-weight: 400;\">A RAPS\/KPMG informou que 43% dos fabricantes de dispositivos m\u00e9dicos planejam retirar-se do mercado da UE.\u00a0\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Working_with_MDR_consultants\"><\/span><b>Trabalhando com consultores MDR\u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">A falta de acesso f\u00e1cil aos especialistas em MDR \u00e9 um s\u00e9rio obst\u00e1culo para as PMEs de produtos m\u00e9dicos, e as restri\u00e7\u00f5es adicionais de or\u00e7amento e cronograma podem definir sua capacidade de sobreviver no mercado da UE. Entretanto, o uso de plataformas sob demanda e tarefas de terceiriza\u00e7\u00e3o para especialistas diretamente \u00e9 uma forma de resolver a lacuna de habilidades.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Erpolat explica que ela notou um aumento acentuado na demanda por redatores de relat\u00f3rios de avalia\u00e7\u00e3o cl\u00ednica em todas as classes de dispositivos m\u00e9dicos, incluindo os da categoria software-como-um-dispositivo m\u00e9dico. Cada dispositivo m\u00e9dico requer um documento CER, que compreende todas as informa\u00e7\u00f5es de avalia\u00e7\u00e3o de dados cl\u00ednicos, instru\u00e7\u00f5es de seguran\u00e7a e desempenho, revis\u00f5es de literatura e muito mais. A contrata\u00e7\u00e3o de especialistas freelance para esta tarefa pode economizar tempo e dinheiro preciosos para os fabricantes de produtos m\u00e9dicos, ao mesmo tempo em que reduz o risco de serem retirados do mercado.\u00a0\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Muitas PMEs tamb\u00e9m est\u00e3o simplesmente inseguras quanto ao caminho a seguir. Embora existam organiza\u00e7\u00f5es estabelecidas que oferecem servi\u00e7os de conformidade regulamentar, elas tamb\u00e9m envolvem processos e contratos mais complexos. A disponibilidade de consultores MDR na Kolabtree que podem aconselhar diretamente sobre uma estrat\u00e9gia regulat\u00f3ria, avalia\u00e7\u00e3o de lacunas MDR da UE ou resolver quest\u00f5es espec\u00edficas torna o processo mais f\u00e1cil, mais r\u00e1pido e indolor.<\/span><\/p>\n<p><strong>Precisa de ajuda com a conformidade regulamentar de seu dispositivo m\u00e9dico? Fale com um dispositivo m\u00e9dico <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations-mdr\">Especialista em conformidade com a RDM da UE<\/a> em Kolabtree ou trabalhar diretamente com um <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">redator de relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica freelance<\/a>. \u00c9 gr\u00e1tis para postar seu projeto e receber or\u00e7amentos.<\/strong><\/p>\n<p>Peritos relacionados:<\/p>\n<p><a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Consultores de Produtos m\u00e9dicos<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Escritor M\u00e9dico Freelancer<\/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=MDRResourceCrunch\">Escritor aut\u00f4nomo do CER<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device-regulations--mdr-?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Consultores MDR da UE<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/fda-submissions?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Envios da FDA<\/a> | <a href=\"https:\/\/www.kolabtree.com\/services\/literature-search?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Especialistas em Pesquisa de Literatura<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-compliance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Peritos em Conformidade Regulat\u00f3ria<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Especialista em ensaios cl\u00ednicos<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Escritores Reguladores<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/post-market-surveillance?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Consultores PMS<\/a> | <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=MDRResourceCrunch\">Consultores da PMCF<\/a> | <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/biostatistics?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDRResourceCrunch\">Especialistas em Bioestat\u00edstica<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>This article outlines the challenges medical device manufacturers are facing with EU MDR compliance and the availability of freelance CER writers and MDR consultants as a solution.\u00a0 Update 13 May 2020: The EU MDR Is now postponed to 26 May 2021 in light of COVID-19. This gives medical device companies more time to prepare for<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/medical-device-eu-mdr-compliance-challenges-and-resource-crunch\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":6874,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[499,535,474],"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>Medical Device EU MDR Compliance: Challenges and Resource Crunch<\/title>\n<meta name=\"description\" content=\"An outline of challenges and barriers medical device manufacturers are facing with EU MDR Compliance and how to overcome them.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link 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