{"id":10083,"date":"2022-07-08T09:56:47","date_gmt":"2022-07-08T09:56:47","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=10083"},"modified":"2023-03-06T11:50:12","modified_gmt":"2023-03-06T11:50:12","slug":"mdr-updates-2022-kolabtree","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/","title":{"rendered":"MDR Updates and Trends - O Guia Definitivo para Regulamentos de Dispositivos M\u00e9dicos"},"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-69f2299c97733\" 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-69f2299c97733\"><\/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\/mdr-updates-2022-kolabtree\/#MDR_updates_you_need_to_know\" title=\"Atualiza\u00e7\u00f5es MDR que voc\u00ea precisa saber\">Atualiza\u00e7\u00f5es MDR que voc\u00ea precisa saber<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#TableFig_1_Highlights_of_the_major_MDR_updates\" title=\"Tabela\/Fig. 1: Destaques das principais atualiza\u00e7\u00f5es do MDR\u00a0 \u00a0\">Tabela\/Fig. 1: Destaques das principais atualiza\u00e7\u00f5es do MDR\u00a0 \u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#Keeping_up_with_the_MDCG_-_MDR_updates\" title=\"Acompanhando as atualiza\u00e7\u00f5es do MDCG - MDR\">Acompanhando as atualiza\u00e7\u00f5es do MDCG - MDR\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#MDCG_position_paper_2022-11_released_in_June_2022\" title=\"MDCG position paper 2022-11 (lan\u00e7ado em junho de 2022)\">MDCG position paper 2022-11 (lan\u00e7ado em junho de 2022)<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#How_can_hiring_expert_medical_writers_help_you\" title=\"Como a contrata\u00e7\u00e3o de escritores m\u00e9dicos especialistas pode ajud\u00e1-lo?\">Como a contrata\u00e7\u00e3o de escritores m\u00e9dicos especialistas pode ajud\u00e1-lo?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#Role_of_regulatory_medical_writers\" title=\"Papel dos escritores m\u00e9dicos reguladores\">Papel dos escritores m\u00e9dicos reguladores<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#Where_does_Kolabtree_fit_in_this\" title=\"Onde a Kolabtree se encaixa nisto?\">Onde a Kolabtree se encaixa nisto?<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/#References\" title=\"Refer\u00eancias\">Refer\u00eancias<\/a><\/li><\/ul><\/nav><\/div>\n<p><span style=\"font-weight: 400;\">Acompanhar as atualiza\u00e7\u00f5es oportunas da UE MDR \u00e9 crucial para as empresas de produtos m\u00e9dicos, permitindo-lhes garantir a ades\u00e3o ao conjunto de regulamentos que regem a comercializa\u00e7\u00e3o e venda de produtos m\u00e9dicos no espa\u00e7o econ\u00f4mico europeu. <\/span><\/p>\n<p><em><span style=\"font-weight: 400;\">This article, authored by Kolabtree&#8217;s freelance scientist <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/aditi-kandlur\">Aditi Kandlur,<\/a> elaborates on the MDR updates you need to keep an eye on as we traverse 2022. Aditi is a molecular biologist with a passion for writing and changing the world one step at a time. She can be contacted on Kolabtree for freelance projects related to medical writing, molecular biology and behavioural neuroscience.<\/span><\/em><\/p>\n<p><span style=\"font-weight: 400;\">Em todo o mundo, os dispositivos m\u00e9dicos e <a href=\"https:\/\/www.kolabtree.com\/blog\/pioneering-medtech-healthcare-companies-in-europe\/\">medtech<\/a> sectors of industries aim to place high-quality products capable of delivering quality healthcare to patients. However, attaining such a status of high quality requires companies to invest their resources into strategic planning, <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">pesquisa<\/a> and development, engineering and compliance with <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-compliance\">normas reguladoras.<\/a>\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O <\/span><a href=\"https:\/\/www.who.int\/activities\/prioritizing-medical-devices\"><span style=\"font-weight: 400;\">OMS<\/span><\/a><span style=\"font-weight: 400;\"> tamb\u00e9m ap\u00f3ia e enfatiza que seus Estados-Membros desenvolvem e implementam tais medidas e pol\u00edticas atrav\u00e9s do \"Modelo Global de Marco Regulat\u00f3rio para Dispositivos M\u00e9dicos, incluindo dispositivos m\u00e9dicos de diagn\u00f3stico in vitro\".<\/span><\/p>\n<p><span style=\"font-weight: 400;\">In the European region, the European Medicines Agency (EMA) oversees the regulatory process while advising on scientific matters to other designated organizations\/notified bodies. Each European Union(EU) Member State has an accredited notified body responsible for performing conformity assessments and evaluations of medical device or medtech manufacturers. Passing the inspection validates the manufacturers with the <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices\"><span style=\"font-weight: 400;\">CE (Conformit\u00e9 Europ\u00e9enne)<\/span><\/a><span style=\"font-weight: 400;\"> marca no dispositivo m\u00e9dico.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A certifica\u00e7\u00e3o da marca CE faz com que o produto <\/span><a href=\"https:\/\/cemarking.net\/how-do-you-benefit-from-ce-marking\/\"><span style=\"font-weight: 400;\">aberto ao com\u00e9rcio<\/span><\/a><span style=\"font-weight: 400;\"> na UE. O credenciamento tamb\u00e9m denota que o produto est\u00e1 em conformidade com todos os requisitos regulamentares sob a nova <\/span><span style=\"font-weight: 400;\">Regulamento de Dispositivos M\u00e9dicos (MDR updates 2017\/745). Este <\/span><a href=\"https:\/\/cemarking.net\/how-do-you-benefit-from-ce-marking\/\"><span style=\"font-weight: 400;\">Benef\u00edcios da marca\u00e7\u00e3o CE<\/span><\/a><span style=\"font-weight: 400;\"> os fabricantes, na medida em que eles t\u00eam que aderir a um conjunto uniforme de diretrizes enquanto projetam e fabricam seus produtos em todo o Espa\u00e7o Econ\u00f4mico Europeu (EEE). Estas diretrizes garantem que produtos mais seguros cheguem ao usu\u00e1rio, reduzindo assim as reclama\u00e7\u00f5es contra responsabilidade ou danos.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O <\/span><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/medical-device-regulation-comes-application\"><span style=\"font-weight: 400;\">MDR<\/span><\/a> <span style=\"font-weight: 400;\">foi introduzido em abril de 2017, mas adotado mais tarde em maio de 2017. As partes interessadas levaram um tempo consider\u00e1vel antes de fazer a transi\u00e7\u00e3o para a nova estrutura. O MDR fornece mudan\u00e7as novas e revisadas na estrutura legal relacionada aos dispositivos m\u00e9dicos. Ao mesmo tempo, tamb\u00e9m reestrutura as responsabilidades funcionais e acomodat\u00edcias da EMA e seus organismos notificados associados dos estados membros da UE.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"MDR_updates_you_need_to_know\"><\/span><b>Atualiza\u00e7\u00f5es MDR que voc\u00ea precisa saber<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">As atualiza\u00e7\u00f5es do MDR para 2022 tiveram algumas modifica\u00e7\u00f5es espec\u00edficas feitas pela Comiss\u00e3o Europ\u00e9ia, a maioria das quais foram acrescentadas \u00e0 estrutura padr\u00e3o do MDR estabelecida em 2021. Estas nove novas cl\u00e1usulas adicionais envolvem marketing, avalia\u00e7\u00f5es biol\u00f3gicas, sistemas de gerenciamento de qualidade, bem como a esteriliza\u00e7\u00e3o de dispositivos m\u00e9dicos e\/ou produtos m\u00e9dicos associados, entre outros. <\/span><span style=\"font-weight: 400;\">(Tabela 1\/Fig 1).\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Segundo a Comiss\u00e3o, \"os dispositivos que est\u00e3o em conformidade com as normas harmonizadas relevantes, ou as partes relevantes dessas normas, cujas refer\u00eancias tenham sido publicadas no <\/span><b>Jornal Oficial da Uni\u00e3o Europ\u00e9ia<\/b><span style=\"font-weight: 400;\">devem ser presumidos em conformidade com as exig\u00eancias desse regulamento cobertas por essas normas ou partes delas\".<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Em maio de 2022, um novo sistema de classifica\u00e7\u00e3o para companheiro\/ <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> diagn\u00f3sticos foi introduzido. Eles estabeleceram o papel e a necessidade de ferramentas de diagn\u00f3stico companheiro para identificar a compatibilidade com os pacientes aos quais s\u00e3o oferecidos dispositivos m\u00e9dicos como modo de tratamento. Todas essas novas regulamenta\u00e7\u00f5es foram aplicadas para capacitar os fabricantes com clareza, de modo que eles possam cumprir as normas de forma eficiente.\u00a0<\/span><\/p>\n<p>&nbsp;<\/p>\n<h2><span class=\"ez-toc-section\" id=\"TableFig_1_Highlights_of_the_major_MDR_updates\"><\/span><b>Tabela\/Fig. 1: Destaques das principais atualiza\u00e7\u00f5es do MDR\u00a0 \u00a0<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>&nbsp;<\/p>\n<table>\n<tbody>\n<tr>\n<td><b>Nome da diretriz<\/b><\/td>\n<td><b>Breve descri\u00e7\u00e3o\/ Cl\u00e1usula<\/b><\/td>\n<td><b>Data de vig\u00eancia<\/b><\/td>\n<td><b>Per\u00edodo de transi\u00e7\u00e3o solicitado<\/b><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Diretriz sobre documenta\u00e7\u00e3o de qualidade para produtos medicinais quando usados com um dispositivo m\u00e9dico<\/span><\/p>\n<p><span style=\"font-weight: 400;\">(EMA\/CHMP\/QWP\/BWP\/259165\/2019)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Esta diretriz instrui as partes interessadas a apresentar aspectos de qualidade espec\u00edficos de um produto m\u00e9dico, ou pe\u00e7a de dispositivo, que possam ter um impacto na qualidade, seguran\u00e7a e\/ou efic\u00e1cia do dispositivo m\u00e9dico. Estas informa\u00e7\u00f5es relacionadas \u00e0 qualidade devem ser apresentadas no dossi\u00ea de autoriza\u00e7\u00e3o de comercializa\u00e7\u00e3o e de acordo com a Diretiva 2001\/83\/CE e\/ou o Regulamento (CE) 726\/2004.\u00a0<\/span><\/td>\n<td><span style=\"font-weight: 400;\">1 de janeiro de 2022<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Nenhum<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">Decis\u00e3o de implementa\u00e7\u00e3o da Comiss\u00e3o (UE) 2022\/6<\/span><\/td>\n<td><span style=\"font-weight: 400;\">6. EN ISO 10993-9:2021- Avalia\u00e7\u00e3o biol\u00f3gica de dispositivos m\u00e9dicos - Parte 9: Estrutura para identifica\u00e7\u00e3o e quantifica\u00e7\u00e3o de produtos com potencial de degrada\u00e7\u00e3o\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">7. EN ISO 10993-12:2021- Avalia\u00e7\u00e3o biol\u00f3gica de dispositivos m\u00e9dicos - Parte 12: Prepara\u00e7\u00e3o de amostras e materiais de refer\u00eancia\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">8. EN ISO 11737-1:2018- Sterilization of health care products &#8211; Microbiological methods &#8211; Part 1: Determination of a population of microorganisms on products\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">9. EN ISO 13408-6:2021- Processamento ass\u00e9ptico de produtos de sa\u00fade - Parte 6: Sistemas isoladores\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">10. EN <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/iso-13485\" target=\"_blank\" rel=\"noopener\">ISO 13485<\/a>:2016- Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes<\/span><\/p>\n<p><span style=\"font-weight: 400;\">11. EN ISO 14160:2021- Sterilization of health care products &#8211; Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives &#8211; Requirements for characterization, development, validation and routine control of a sterilization process for medical devices<\/span><\/p>\n<p><span style=\"font-weight: 400;\">12. EN ISO 15223-1:2021- Dispositivos m\u00e9dicos - S\u00edmbolos a serem usados com informa\u00e7\u00f5es a serem fornecidas pelo fabricante - Parte 1: Exig\u00eancias gerais<\/span><\/p>\n<p><span style=\"font-weight: 400;\">13. EN ISO 17664-1:2021- Processamento de produtos m\u00e9dicos - Informa\u00e7\u00f5es a serem fornecidas pelo fabricante do dispositivo m\u00e9dico para o processamento de dispositivos m\u00e9dicos - Parte 1: Dispositivos m\u00e9dicos cr\u00edticos e semi-cr\u00edticos<\/span><\/p>\n<p><span style=\"font-weight: 400;\">14. 14. PT IEC 60601-2-83:2020- Equipamento el\u00e9trico m\u00e9dico - Parte 2-83: Requisitos particulares para a seguran\u00e7a b\u00e1sica e desempenho essencial do equipamento de terapia com luz dom\u00e9stica<\/span><\/td>\n<td><span style=\"font-weight: 400;\">4 de janeiro de 2022<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Nenhum<\/span><\/td>\n<\/tr>\n<tr>\n<td><i><span style=\"font-weight: 400;\">In-Vitro<\/span><\/i><span style=\"font-weight: 400;\"> Regulamento de Dispositivos de Diagn\u00f3stico (Regulamento (UE) 2017\/746)<\/span><\/td>\n<td><span style=\"font-weight: 400;\">As diretrizes trazem um novo sistema de classifica\u00e7\u00e3o para companheiro\/ <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> diagn\u00f3sticos que identificam pacientes compat\u00edveis com o produto m\u00e9dico como meio de tratamento.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">26 de maio de 2022<\/span><\/td>\n<td><span style=\"font-weight: 400;\">5 anos<\/span><\/td>\n<\/tr>\n<tr>\n<td><span style=\"font-weight: 400;\">MDCG 2019-9 Rev.1 muda<\/span><\/td>\n<td><span style=\"font-weight: 400;\">Atualiza\u00e7\u00f5es da MDR em rela\u00e7\u00e3o \u00e0 elabora\u00e7\u00e3o de resumos de seguran\u00e7a e desempenho cl\u00ednico para dispositivos de alto risco, tais como dispositivos implant\u00e1veis e Classe III, durante a avalia\u00e7\u00e3o pelo organismo notificado. Eles tamb\u00e9m detalharam uma exig\u00eancia dos fabricantes, atribuindo um c\u00f3digo\/n\u00famero de refer\u00eancia \u00fanico a tais resumos. Esta medida visa trazer mais transpar\u00eancia e facilidade de acesso \u00e0 informa\u00e7\u00e3o.<\/span><\/td>\n<td><span style=\"font-weight: 400;\">24 de mar\u00e7o de 2022<\/span><\/td>\n<td><span style=\"font-weight: 400;\">2 anos para dispositivos m\u00e9dicos e implant\u00e1veis da classe 3; 4 anos para outros<\/span><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<h2><\/h2>\n<h2><span class=\"ez-toc-section\" id=\"Keeping_up_with_the_MDCG_-_MDR_updates\"><\/span><strong>Acompanhando as atualiza\u00e7\u00f5es do MDCG - MDR\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">O Grupo de Coordena\u00e7\u00e3o de Produtos m\u00e9dicos (MDCG) foi estabelecido pelo MDR. O painel do MDCG inclui pelo menos um\/dois especialistas de cada estado membro e dois deputados. Os membros do painel s\u00e3o selecionados com base em sua experi\u00eancia em medicina e <\/span><i><span style=\"font-weight: 400;\">in vitro<\/span><\/i><span style=\"font-weight: 400;\"> dispositivos de diagn\u00f3stico. O painel \u00e9 nomeado por um per\u00edodo de tr\u00eas anos.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">O MDCG tem uma s\u00e9rie de fun\u00e7\u00f5es que influenciam muito os fabricantes, bem como os \u00f3rg\u00e3os reguladores notificados.<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Fornecendo orienta\u00e7\u00e3o para a implementa\u00e7\u00e3o sistem\u00e1tica do MDR<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Monitorar o progresso t\u00e9cnico, bem como desenvolver normas e padr\u00f5es\u00a0<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Avalia\u00e7\u00e3o dos \u00d3rg\u00e3os Notificados dos Estados membros<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Assisting competent authorities in a wide range of regulatory areas.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Ponto focal para a Comiss\u00e3o Europ\u00e9ia coordenar o funcionamento do Grupo de Coordena\u00e7\u00e3o do \u00d3rg\u00e3o Notificado sob o Artigo 49.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">O MDCG tem uma influ\u00eancia ineg\u00e1vel na implementa\u00e7\u00e3o do Regulamento e, portanto, n\u00e3o deve ser subestimado. O painel foi respons\u00e1vel por fazer a transi\u00e7\u00e3o do MDD 93\/42\/EEC para o novo <\/span><span style=\"font-weight: 400;\">MDR 2017\/745. As atualiza\u00e7\u00f5es MDR e as diretrizes IVDR pelo MDCG substitu\u00edram os documentos MEDDEV mais antigos. \u00c9 importante para as empresas fabricantes observar que estas diretrizes do MDCG s\u00e3o <\/span><b>n\u00e3o <\/b><span style=\"font-weight: 400;\">legalmente vinculante, no entanto, a escolha mais inteligente seria cuidadosamente considerada e implementada na pr\u00e1tica quando e como necess\u00e1rio. O MDCG faz cumprir a implementa\u00e7\u00e3o do regulamento atrav\u00e9s do Artigo 105 do MDR, que declara que eles s\u00e3o respons\u00e1veis por contribuir para \"uma implementa\u00e7\u00e3o eficaz e harmonizada do regulamento\".\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Atrav\u00e9s do MDCG, as normas de refer\u00eancia para demonstrar a seguran\u00e7a e o desempenho de seus produtos aumentaram para os fabricantes. As diretrizes s\u00e3o mais flex\u00edveis e inclusivas quando comparadas com a Diretiva de Dispositivos M\u00e9dicos (MDD). Os relat\u00f3rios de qualidade enviados pelos fabricantes s\u00e3o baseados em estudos cl\u00ednicos patrocinados pelo fabricante e ou em literatura revisada por pares que se concentra exclusivamente no dispositivo em quest\u00e3o. Estas fontes de dados s\u00e3o vistas como um padr\u00e3o ouro e tamb\u00e9m como a evid\u00eancia mais direta em apoio a um dispositivo.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"MDCG_position_paper_2022-11_released_in_June_2022\"><\/span>MDCG position paper 2022-11 (lan\u00e7ado em junho de 2022)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">O MDCG libera documentos de posi\u00e7\u00e3o que n\u00e3o s\u00e3o juridicamente vinculativos e n\u00e3o s\u00e3o documentos da Comiss\u00e3o Europ\u00e9ia. Entretanto, tais documentos s\u00e3o considerados como refletindo a posi\u00e7\u00e3o oficial da Comiss\u00e3o Europ\u00e9ia.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">On 13 June 2022, a Position paper <\/span><a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-11-mdcg-position-paper-notice-manufacturers-ensure-timely-compliance-mdr-requirements-2022-06-13_en\"><span style=\"font-weight: 400;\">MDCG 2022-11<\/span><\/a><span style=\"font-weight: 400;\"> foi publicado no site da Comiss\u00e3o Europ\u00e9ia e endossado pelo MDCG. O MDCG 2022-11 serve como um aviso aos fabricantes com o objetivo de garantir o cumprimento oportuno das exig\u00eancias do MDR. O documento fala com a inten\u00e7\u00e3o de garantir que os dispositivos m\u00e9dicos possam continuar a ser colocados no mercado sem escassez. Ele destaca que \u00e9 crucial que todos os fabricantes desenvolvam seu sistema - envolvendo etapas para finalizar a transi\u00e7\u00e3o para o MDR e obter a marca CE ap\u00f3s a solicita\u00e7\u00e3o a um organismo notificado, apresentando solicita\u00e7\u00f5es completas e em conformidade. O MDCG enfatiza que os fabricantes devem agir o mais r\u00e1pido poss\u00edvel e estar bem \u00e0 frente nos procedimentos antes do final do per\u00edodo de transi\u00e7\u00e3o para garantir a conformidade em tempo h\u00e1bil.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Isto ocorre em um momento em que aproximadamente \"70 % de certificados AIMDD\/MDD expirar\u00e3o em 2024 (no m\u00e1ximo at\u00e9 26 de maio de 2024)\". O MDCG instrui os fabricantes a tomarem as medidas apropriadas, pois os organismos notificados podem n\u00e3o ser capazes de avaliar todos os arquivos correspondentes devido a um poss\u00edvel aumento na documenta\u00e7\u00e3o dentro dos primeiros meses de 2024.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"How_can_hiring_expert_medical_writers_help_you\"><\/span><b>Como a contrata\u00e7\u00e3o de escritores m\u00e9dicos especialistas pode ajud\u00e1-lo?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">A transi\u00e7\u00e3o de MDD para MDR \u00e9 um desafio que os fabricantes enfrentam. Eles precisariam tomar decis\u00f5es inteligentes que permitissem que o processo fosse sistem\u00e1tico e organizado. Isto exigiria que as empresas contratassem partes interessadas que tivessem a experi\u00eancia e a habilidade para se especializar em dispositivos m\u00e9dicos e na regulamenta\u00e7\u00e3o europ\u00e9ia MDR (EU MDR 2017\/745) e ajudassem a empresa atrav\u00e9s de uma mistura de compet\u00eancias cient\u00edficas, m\u00e9dicas\/cl\u00ednicas, reguladoras e t\u00e9cnicas.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Estas partes interessadas s\u00e3o redatores m\u00e9dicos reguladores\/<a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-reports-cer\"> Redatores do Relat\u00f3rio de Avalia\u00e7\u00e3o Cl\u00ednica (CER)<\/a> que apresentam an\u00e1lise de dados cl\u00ednicos e evid\u00eancias ou mesmo revis\u00f5es de literatura ap\u00f3s realizar a an\u00e1lise de lacunas (para a transi\u00e7\u00e3o MDD-MDR).<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Quais s\u00e3o algumas habilidades e experi\u00eancias relevantes para se concentrar ao avaliar a possibilidade de se contratar um redator de CER? \u00c9 amplamente reconhecido que encontrar tais escritores m\u00e9dicos especializados \u00e9 um grande inc\u00f4modo. Eles tamb\u00e9m t\u00eam vasta experi\u00eancia em escrever documentos tais como <a href=\"https:\/\/www.kolabtree.com\/blog\/medical-device-clinical-evaluation-report-sample-free\/\">protocolos cl\u00ednicos<\/a>, informed consent documents, and clinical study reports (CSR), whilst also helping in clinical trial\/study data analyses. The challenge comes while hiring the right personnel\/team who can juggle regulatory affairs and technical medical\/CER writing. If needed, the company can recruit a team consisting of CER\/medical writers and medical doctors who can serve as the source of information about their expertise that lies in the specific therapeutic area.<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Role_of_regulatory_medical_writers\"><\/span><b>Papel dos escritores m\u00e9dicos reguladores<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\">Escritores m\u00e9dicos reguladores<\/a> s\u00e3o geralmente cientistas ou cl\u00ednicos por profiss\u00e3o ou treinamento. Eles trabalham atrav\u00e9s das diferentes etapas dos processos de certifica\u00e7\u00e3o para preparar documentos t\u00e9cnicos. Normalmente, eles s\u00e3o especializados em documenta\u00e7\u00e3o para candidatos a medicamentos e dispositivos m\u00e9dicos, juntamente com produtos m\u00e9dicos associados.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">A principal responsabilidade dos escritores m\u00e9dicos \u00e9 proteger os dados dos pacientes nos documentos atrav\u00e9s de t\u00e9cnicas apropriadas de anonimiza\u00e7\u00e3o. Isto inclui v\u00e1rios meios, tais como evitar o uso de identificadores diretos (IDs) que s\u00e3o diretamente atribu\u00edveis a um indiv\u00edduo espec\u00edfico, tais como nomes, iniciais, endere\u00e7os, etc.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">That includes even masking\/ generalizing quasi-IDs such as sex, race, birth dates etc. This is done to avoid patient re-identification or tracing back of patients. With regards to medical devices, medical writers do not provide specific details- serial numbers or any other device identifiers.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">The responsibilities of medical writers are summarized as per the EMA Policy 0070: &#8220;what [we]ultimately want to achieve is to retain a maximum of scientifically useful information on medicinal products for the benefit of the public while achieving adequate anonymisation.&#8221;<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Where_does_Kolabtree_fit_in_this\"><\/span><b>Onde a Kolabtree se encaixa nisto?<\/b><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Kolabtree serve como uma plataforma para conectar <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\">dispositivo m\u00e9dico, <\/a><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/science-communication\">biotecnologia<\/a> e empresas farmac\u00eauticas, entre outras, a um grande corpo de especialistas independentes altamente qualificados como <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/product-development\">consultores cient\u00edficos<\/a>editores m\u00e9dicos e <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\">escritores<\/a> que oferecem seus servi\u00e7os sob demanda. Estes freelancers trabalham com clientes dentro da plataforma segura Kolabtree, ajudando empresas de biotecnologia, organiza\u00e7\u00f5es de dispositivos m\u00e9dicos, empresas farmac\u00eauticas ou organiza\u00e7\u00f5es de pesquisa contratadas (CROs), companhias de seguro de sa\u00fade, autoridades de sa\u00fade, institui\u00e7\u00f5es de caridade, ag\u00eancias governamentais e para-governamentais, e organiza\u00e7\u00f5es de m\u00e9dicos, entre outras.<\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-hire-a-remote-science-writer\/\">Terceiriza\u00e7\u00e3o<\/a> pode vir a ser uma grande estrat\u00e9gia para atender a demandas cr\u00edticas de projetos. <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\">Escritores m\u00e9dicos freelance<\/a> pode revelar-se um excelente recurso para empresas que precisam de suas habilidades regularmente para obter os melhores resultados. Isto tamb\u00e9m oferece \u00e0s empresas menores uma chance de contratar consultores em regime de pay-as-you-go, testando novas id\u00e9ias ou concluindo projetos de dura\u00e7\u00e3o fixa sem ter que contratar um recurso interno. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Kolabtree, uma plataforma segura que tamb\u00e9m garante <a href=\"https:\/\/www.kolabtree.com\/blog\/3-ways-kolabtree-guarantees-data-security-whilst-hiring-freelancers\/\">confidencialidade da data<\/a> e pagamentos seguros, tem escritores especializados certificados pela Associa\u00e7\u00e3o Europ\u00e9ia de Escritores M\u00e9dicos (EMWA), a Associa\u00e7\u00e3o Americana de Escritores M\u00e9dicos (AMWA), ou a Associa\u00e7\u00e3o Internacional de Escritores Cient\u00edficos (ISWA).<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"References\"><\/span><strong>Refer\u00eancias<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ol>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.who.int\/activities\/prioritizing-medical-devices\"><span style=\"font-weight: 400;\">Priorizando os dispositivos m\u00e9dicos (who.int)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory\/overview\/medical-devices\"><span style=\"font-weight: 400;\">Dispositivos m\u00e9dicos | Ag\u00eancia Europ\u00e9ia de Medicamentos (europa.eu)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.emergobyul.com\/resources\/europe-medical-devices-regulation-mdr-ce-marking-regulatory-process\"><span style=\"font-weight: 400;\">Europa Regulamenta\u00e7\u00e3o de Dispositivos M\u00e9dicos (MDR) Processo de Regulamenta\u00e7\u00e3o da Marca\u00e7\u00e3o CE (emergobyul.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.qvccert.com\/product-certification\/medical-devices-ce-marking\/\"><span style=\"font-weight: 400;\">Dispositivos m\u00e9dicos - Marca\u00e7\u00e3o CE - Marca\u00e7\u00e3o CE, Marca Ce, Marca\u00e7\u00e3o de Produto, Certifica\u00e7\u00e3o de Sistema (qvccert.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/cemarking.net\/how-do-you-benefit-from-ce-marking\/\"><span style=\"font-weight: 400;\">Como voc\u00ea se beneficia da marca\u00e7\u00e3o CE?<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/biocodexphame.fi\/articles\/why-is-it-important-to-have-ce-marking-for-medical-devices\"><span style=\"font-weight: 400;\">Por que \u00e9 importante ter a marca\u00e7\u00e3o CE para dispositivos m\u00e9dicos - Biocodex (biocodexphame.fi)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2022\/1\/european-commission-publishes-second-batch-of-harm\"><span style=\"font-weight: 400;\">A Comiss\u00e3o Europ\u00e9ia publica o segundo lote de normas harmonizadas sob MDR | RAPS<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.celegence.com\/regulatory-challenges-writing-eumdr-compliant-clinical-evaluation-reports-cer\/\"><span style=\"font-weight: 400;\">Desafios regulamentares na reda\u00e7\u00e3o de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica (CER) (celegence.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.seleon.com\/en\/regulatory-affairs\/meddev-is-going-mdcg-is-coming-an-update-of-the-guidance-documents\/\"><span style=\"font-weight: 400;\">MEDDEV est\u00e1 indo, MDCG est\u00e1 chegando - uma atualiza\u00e7\u00e3o dos documentos de orienta\u00e7\u00e3o - seleon GmbH<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Bilh\u00f5es de d\u00f3lares, Raquel. \"Os dispositivos m\u00e9dicos na era da divulga\u00e7\u00e3o e o papel dos escritores m\u00e9dicos\". <\/span><i><span style=\"font-weight: 400;\">Escrita m\u00e9dica<\/span><\/i><span style=\"font-weight: 400;\"> 26 (2017): 32-34.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/akrnconsulting.com\/the-pillars-of-successful-cer-writing\/#:~:text=Writing%20an%20exemplar%20Clinical%20Evaluation%20Report%20%28CER%29%20requires,that%20master%20such%20a%20broad%20range%20of%20experience%21\"><span style=\"font-weight: 400;\">AKRN | The 4 Pillars of Successful CER Writing | Medical Device CRO (akrnconsulting.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.celegence.com\/regulatory-challenges-writing-eumdr-compliant-clinical-evaluation-reports-cer\/\"><span style=\"font-weight: 400;\">Desafios regulamentares na reda\u00e7\u00e3o de Relat\u00f3rios de Avalia\u00e7\u00e3o Cl\u00ednica (CER) (celegence.com)<\/span><\/a><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><a href=\"https:\/\/www.kolabtree.com\/blog\/why-outsource-biotech-website-content-to-expert-writers\/\"><span style=\"font-weight: 400;\">Por que terceirizar o conte\u00fado do site de biotecnologia para escritores especializados - (kolabtree.com)<\/span><\/a><\/li>\n<\/ol>","protected":false},"excerpt":{"rendered":"<p>Keeping up with timely EU MDR updates is crucial for medical device companies, enabling them to ensure adherence to the set of regulations that govern the marketing and sale of medical device products in the European Economic area. This article, authored by Kolabtree&#8217;s freelance scientist Aditi Kandlur, elaborates on the MDR updates you need to<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":151,"featured_media":10110,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[540],"tags":[535,483,500,474,482],"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>MDR Updates and Trends - The Definitive Guide to Medical Device Regulations - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MDR Updates and Trends - The Definitive Guide to Medical Device Regulations\" \/>\n<meta property=\"og:description\" content=\"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/\" \/>\n<meta property=\"og:site_name\" content=\"The Kolabtree Blog\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/kolabtree\" \/>\n<meta property=\"article:published_time\" content=\"2022-07-08T09:56:47+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-03-06T11:50:12+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/07\/shutterstock_1923647231.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1000\" \/>\n\t<meta property=\"og:image:height\" content=\"667\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Kolabtree\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:site\" content=\"@kolabtree\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Kolabtree\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. tempo de leitura\" \/>\n\t<meta name=\"twitter:data2\" content=\"10 minutos\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"MDR Updates and Trends - The Definitive Guide to Medical Device Regulations - The Kolabtree Blog","description":"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/","og_locale":"pt_BR","og_type":"article","og_title":"MDR Updates and Trends - The Definitive Guide to Medical Device Regulations","og_description":"MDR updates 2022 - All the latest trends, guidelines and updates you need to know about in medical device regulations for 2022.","og_url":"https:\/\/www.kolabtree.com\/blog\/pt\/mdr-updates-2022-kolabtree\/","og_site_name":"The Kolabtree Blog","article_publisher":"https:\/\/www.facebook.com\/kolabtree","article_published_time":"2022-07-08T09:56:47+00:00","article_modified_time":"2023-03-06T11:50:12+00:00","og_image":[{"width":1000,"height":667,"url":"https:\/\/www.kolabtree.com\/blog\/wp-content\/uploads\/2022\/07\/shutterstock_1923647231.jpg","type":"image\/jpeg"}],"author":"Kolabtree","twitter_card":"summary_large_image","twitter_creator":"@kolabtree","twitter_site":"@kolabtree","twitter_misc":{"Escrito por":"Kolabtree","Est. tempo de leitura":"10 minutos"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.kolabtree.com\/blog\/mdr-updates-2022-kolabtree\/#article","isPartOf":{"@id":"https:\/\/www.kolabtree.com\/blog\/mdr-updates-2022-kolabtree\/"},"author":{"name":"Kolabtree","@id":"https:\/\/www.kolabtree.com\/blog\/#\/schema\/person\/39cd88be69e5687afd09ea14960d3e0b"},"headline":"MDR Updates and Trends &#8211; 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