{"id":7609,"date":"2024-08-02T12:44:21","date_gmt":"2024-08-02T11:44:21","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7609"},"modified":"2025-01-20T15:58:04","modified_gmt":"2025-01-20T15:58:04","slug":"ue-divulga-consensus-statement-dispositivos-medicos","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/pt-pt\/ue-divulga-consensus-statement-dispositivos-medicos\/","title":{"rendered":"UE publica &#8216;Consensus Statement&#8217; sobre Dispositivos M\u00e9dicos"},"content":{"rendered":"<p>As Autoridades Nacionais Competentes da Uni\u00e3o Europeia, com o papel ativo do INFARMED, I.P., aprovaram um <strong>\u201cconsensus statement\u201d<\/strong> que avalia o estado atual do quadro regulamentar europeu para dispositivos m\u00e9dicos.<\/p>\n<p>O documento, partilhado com a Comiss\u00e3o Europeia, identifica prioridades comuns para a\u00e7\u00f5es futuras e aborda os desafios enfrentados na implementa\u00e7\u00e3o dos Regulamentos Europeus sobre dispositivos m\u00e9dicos (2017\/745) e dispositivos de diagn\u00f3stico in vitro (2017\/746).<\/p>\n<h2><strong>Workshop em Fran\u00e7a sobre Regulamenta\u00e7\u00e3o de Dispositivos M\u00e9dicos<\/strong><\/h2>\n<p>A 10 de julho de 2024, os representantes da Comiss\u00e3o Europeia, juntamente com as autoridades competentes, estiveram reunidos num workshop em Fran\u00e7a.<\/p>\n<p>Desenvolvido para discutir a aplica\u00e7\u00e3o pr\u00e1tica dos regulamentos, este evento foi promovido pelo HMA Core Group e j\u00e1 contou com o apoio da Comiss\u00e3o Europeia.<\/p>\n<h3>Quais os <strong>objetivos principais do workshop<\/strong>?<\/h3>\n<ul>\n<li>Fazer um ponto de situa\u00e7\u00e3o sobre a implementa\u00e7\u00e3o dos regulamentos.<\/li>\n<li>Contribuir para a avalia\u00e7\u00e3o direcionada (\u201cTargeted Evaluation\u201d) conduzida pela Comiss\u00e3o Europeia.<\/li>\n<\/ul>\n<h3><strong>Conhe\u00e7a os quatro pilares tem\u00e1ticos discutidos<\/strong>:<\/h3>\n<ol>\n<li><strong>Acesso &amp; Disponibilidade<\/strong>.<\/li>\n<li><strong>Seguran\u00e7a<\/strong>.<\/li>\n<li><strong>Inova\u00e7\u00e3o<\/strong>.<\/li>\n<li><strong>Governa\u00e7\u00e3o &amp; Coordena\u00e7\u00e3o<\/strong>.<\/li>\n<\/ol>\n<p>Durante o workshop, foi destacada a necessidade de uma abordagem colaborativa para superar os desafios atuais. As autoridades enfatizaram que o equil\u00edbrio entre seguran\u00e7a, inova\u00e7\u00e3o e acessibilidade \u00e9 fundamental para garantir um sistema eficaz.<\/p>\n<h2><strong>Desafios e Compromissos das Autoridades Competentes<\/strong><\/h2>\n<p>Por um lado, foi destacada a import\u00e2ncia do quadro regulamentar para a prote\u00e7\u00e3o da sa\u00fade p\u00fablica e para o incentivo \u00e0 inova\u00e7\u00e3o tecnol\u00f3gica na \u00e1rea m\u00e9dica.<\/p>\n<h4>Por outro lado, tamb\u00e9m foram reconhecidas dificuldades como:<\/h4>\n<ul>\n<li>Atrasos na transi\u00e7\u00e3o para os novos regulamentos.<\/li>\n<li>Custos elevados e imprevis\u00edveis.<\/li>\n<li>Riscos de descontinua\u00e7\u00e3o ou escassez de dispositivos m\u00e9dicos essenciais.<\/li>\n<\/ul>\n<p>Outro ponto abordado foi a necessidade de maior previsibilidade para os fabricantes, que enfrentam desafios tanto na certifica\u00e7\u00e3o de novos dispositivos quanto na adapta\u00e7\u00e3o de produtos existentes \u00e0s novas exig\u00eancias regulamentares.<\/p>\n<h4>Apesar destas adversidades, o compromisso foi reafirmado com:<\/h4>\n<ul>\n<li>A confian\u00e7a nos regulamentos como base para proteger a sa\u00fade p\u00fablica.<\/li>\n<li>A colabora\u00e7\u00e3o com a Comiss\u00e3o Europeia e outros stakeholders para superar os desafios.<\/li>\n<\/ul>\n<h3><\/h3>\n<h2><strong>Apelo \u00e0 Comiss\u00e3o Europeia e A\u00e7\u00f5es Futuras<\/strong><\/h2>\n<p>As Autoridades Competentes pedem \u00e0 Comiss\u00e3o Europeia para priorizar a regulamenta\u00e7\u00e3o de dispositivos m\u00e9dicos no pr\u00f3ximo mandato.<\/p>\n<p>Desta forma, as autoridades comprometem-se a trabalhar em parceria para:<\/p>\n<ul>\n<li>Identificar solu\u00e7\u00f5es pr\u00e1ticas para os desafios regulamentares.<\/li>\n<li>Refor\u00e7ar infraestruturas e capacidades, incluindo o sistema EUDAMED.<\/li>\n<li>Garantir um sistema eficiente, seguro e adaptado \u00e0s necessidades dos cidad\u00e3os e da ind\u00fastria.<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h2><strong>Compromisso com um Sistema Regulamentar Sustent\u00e1vel<\/strong><\/h2>\n<p>Assim, o <a href=\"https:\/\/www.infarmed.pt\/documents\/15786\/1147401\/Regulamentos+relativos+aos+Dispositivos+M%C3%A9dicos+e+Diagn%C3%B3stico+In+Vitro%3A+publica%C3%A7%C3%A3o+de+um+%27%27consensus+statement%27%27+das+Autoridades+Competentes+da+UE+dirigido+%C3%A0+Comiss%C3%A3o+Europeia\/c3e32854-7f46-59ff-279b-6e622857206b\">\u00a0<strong>\u201cconsensus statement\u201d<\/strong><\/a> reafirma a relev\u00e2ncia e necessidade dos regulamentos MDR e IVDR para proteger a sa\u00fade p\u00fablica e fomentar a inova\u00e7\u00e3o tecnol\u00f3gica na Europa.<\/p>\n<p>As Autoridades Competentes, incluindo INFARMED, I.P., destacam quais s\u00e3o as decis\u00f5es futuras que devem ser baseadas em evid\u00eancias e an\u00e1lises criteriosas.<\/p>\n<p>Assim, podem ser evitandas interrup\u00e7\u00f5es e assegurando o desenvolvimento cont\u00ednuo do sistema regulamentar europeu.<\/p>\n<p>&nbsp;<\/p>\n<p>Precisa de mais informa\u00e7\u00f5es sobre quest\u00f5es regulat\u00f3rias? A ELS pode ajudar.<\/p>\n<p>Por favor entre em contato com o seu\u00a0<a href=\"https:\/\/els-solutions.com\/onde-estamos\/\">consultor local da ELS<\/a>\u00a0ou atrav\u00e9s do email: <a href=\"mailto:info@elssolutions.pt\">info@elssolutions.pt<\/a><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>O INFARMED,  em conjunto com entidades competentes, divulga &#8216;consensus statement&#8217; da UE sobre dispositivos m\u00e9dicos.<\/p>\n","protected":false},"author":9,"featured_media":7611,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[53,60],"tags":[64],"class_list":["post-7609","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-geral","category-noticias","tag-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v23.4 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>UE divulga Consensus Statement sobre dispositivos m\u00e9dicos<\/title>\n<meta name=\"description\" content=\"O INFARMED, em conjunto com entidades competentes, divulga &#039;consensus statement&#039; 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