{"id":31533,"date":"2026-02-13T09:42:15","date_gmt":"2026-02-13T12:42:15","guid":{"rendered":"https:\/\/sobelconsult.com\/mdr-and-ivdr-under-review\/"},"modified":"2026-10-24T06:39:59","modified_gmt":"2026-10-24T09:39:59","slug":"mdr-and-ivdr-under-review","status":"publish","type":"post","link":"https:\/\/sobelconsult.com\/pt-br\/mdr-and-ivdr-under-review\/","title":{"rendered":"Not\u00edcias: MDR e IVDR em revis\u00e3o, QMSR em vigor e muito mais"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Nos \u00faltimos meses, o setor regulat\u00f3rio tem se concentrado cada vez mais em t\u00f3picos relacionados a MDR e IVDR.<\/p>\n\n<p class=\"wp-block-paragraph\">Na \u00faltima edi\u00e7\u00e3o da Sobel News, abordamos um <a href=\"https:\/\/sobelconsult.com\/pt-br\/impactos-regulatorios-eu-mdr-ivdr\/\">estudo encomendado pela Uni\u00e3o Europeia que analisa o impacto do MDR e do IVDR<\/a> no mercado de dispositivos m\u00e9dicos da regi\u00e3o.<\/p>\n\n<p class=\"wp-block-paragraph\">Agora, no final de janeiro, Bruxelas sediou <strong>discuss\u00f5es sobre poss\u00edveis revis\u00f5es do MDR e do IVDR.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Essa atualiza\u00e7\u00e3o, juntamente com importantes desenvolvimentos regulat\u00f3rios nos Estados Unidos e na China, \u00e9 o foco deste artigo.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-mdr-and-ivdr-under-review-in-the-european-union\"><strong>MDR e IVDR em an\u00e1lise na Uni\u00e3o Europeia<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">As autoridades regulat\u00f3rias da Uni\u00e3o Europeia apresentaram <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/1\/eu-officials-detail-proposed-mdr,-ivdr-revisions\"><strong>propostas iniciais para revisar o MDR e o IVDR<\/strong><\/a> (Regulamenta\u00e7\u00e3o de Dispositivos M\u00e9dicos e Regulamenta\u00e7\u00e3o de Diagn\u00f3stico In Vitro).<\/p>\n\n<p class=\"wp-block-paragraph\">O objetivo \u00e9 ajustar as opera\u00e7\u00f5es regulat\u00f3rias para reduzir os desafios enfrentados pelos fabricantes durante os processos de certifica\u00e7\u00e3o e manuten\u00e7\u00e3o.<\/p>\n\n<p class=\"wp-block-paragraph\">As discuss\u00f5es incluem melhorias na previsibilidade regulat\u00f3ria e poss\u00edveis extens\u00f5es de cronograma em situa\u00e7\u00f5es espec\u00edficas. Elas tamb\u00e9m abordam ajustes de requisitos que afetam a disponibilidade de produtos no mercado europeu. <\/p>\n\n<p class=\"wp-block-paragraph\">Desde sua implementa\u00e7\u00e3o, o MDR e o IVDR aumentaram significativamente os requisitos t\u00e9cnicos e de documenta\u00e7\u00e3o para os fabricantes, fortalecendo os padr\u00f5es de seguran\u00e7a e desempenho.<\/p>\n\n<p class=\"wp-block-paragraph\">No entanto, essa estrutura introduziu desafios, incluindo o aumento dos custos regulat\u00f3rios, a complexidade do processo e a capacidade limitada dos \u00f3rg\u00e3os notificados.<\/p>\n\n<p class=\"wp-block-paragraph\">Basicamente, as revis\u00f5es propostas visam melhorar a efici\u00eancia regulat\u00f3ria sem comprometer os objetivos principais.<\/p>\n\n<p class=\"wp-block-paragraph\">Para os fabricantes, as mudan\u00e7as no MDR e no IVDR podem afetar o planejamento regulat\u00f3rio, as prioridades de mercado e os cronogramas do ciclo de vida do produto.<\/p>\n\n<p class=\"wp-block-paragraph\">Espera-se que esse t\u00f3pico permane\u00e7a altamente relevante nos pr\u00f3ximos meses.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-qmsr-c-omes-into-force-in-the-united-states\"><strong>O QMSR<\/strong><strong>entra em vigor nos Estados Unidos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">A <a href=\"https:\/\/www.raps.org\/news-and-articles\/news-articles\/2026\/2\/qmsr-is-live-expert-says-new-rule-may-be-challengi\"><strong>O novo Regulamento do Sistema de Gerenciamento de Qualidade (QMSR) da FDA entrou em vigor,<\/strong><\/a> alinhando os requisitos do sistema de qualidade de dispositivos m\u00e9dicos com a ISO 13485.<\/p>\n\n<p class=\"wp-block-paragraph\">A atualiza\u00e7\u00e3o representa um passo importante em dire\u00e7\u00e3o \u00e0 harmoniza\u00e7\u00e3o regulat\u00f3ria internacional.<\/p>\n\n<p class=\"wp-block-paragraph\">Na pr\u00e1tica, ela introduz ajustes relevantes nas expectativas de conformidade dos fabricantes que operam no mercado dos EUA, <strong>exigindo <\/strong><a href=\"https:\/\/sobelconsult.com\/pt-br\/registrar-um-dispositivo-medico-no-fda\/sistema-da-qualidade-fda\/\"><strong>atualiza\u00e7\u00f5es nos procedimentos internos, na documenta\u00e7\u00e3o e nos processos de auditoria.<\/strong><\/a><\/p>\n\n<figure class=\"wp-block-image aligncenter size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1000\" height=\"733\" src=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization.jpg\" alt=\"M&#xE3;os masculinas segurando um tablet. Elementos gr&#xE1;ficos representando um sistema de qualidade. \" class=\"wp-image-19982\" srcset=\"https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization.jpg 1000w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization-300x220.jpg 300w, https:\/\/sobelconsult.com\/wp-content\/uploads\/2025\/11\/FDA-ISO-13485-harmonization-768x563.jpg 768w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/figure>\n\n<h2 class=\"wp-block-heading\" id=\"h-china-launches-plan-to-strengthen-quality-systems-in-the-cosmetics-industry\"><strong>China lan\u00e7a plano para fortalecer os sistemas de qualidade no setor de cosm\u00e9ticos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">As autoridades reguladoras chinesas anunciaram um <a href=\"https:\/\/cisema.com\/en\/cosmetics-quality-system-action-plan\/\">plano de a\u00e7\u00e3o para 2026-2028<\/a> com o objetivo de <strong>fortalecer os sistemas de qualidade dos fabricantes de cosm\u00e9ticos.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">A iniciativa inclui uma supervis\u00e3o aprimorada baseada em riscos, um controle mais rigoroso das mat\u00e9rias-primas e o monitoramento cont\u00ednuo da conformidade durante todo o ciclo de vida do produto.<\/p>\n\n<p class=\"wp-block-paragraph\">Certamente, isso sinaliza um claro aumento nas expectativas regulat\u00f3rias para as empresas que fabricam ou exportam para o mercado chin\u00eas.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-publishes-draft-guidance-for-cosmetics\"><strong>FDA publica vers\u00e3o preliminar de orienta\u00e7\u00e3o para cosm\u00e9ticos<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">A FDA divulgou <a href=\"https:\/\/www.fda.gov\/media\/190681\/download\">um esbo\u00e7o de orienta\u00e7\u00e3o <strong>que descreve a seguran\u00e7a atualizada e as expectativas regulat\u00f3rias<\/strong><\/a><strong> aplic\u00e1veis aos produtos cosm\u00e9ticos.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">O documento <strong>refor\u00e7a a necessidade de documenta\u00e7\u00e3o t\u00e9cnica robusta, manuten\u00e7\u00e3o de registros adequados e pr\u00e1ticas de monitoramento p\u00f3s-comercializa\u00e7\u00e3o refor\u00e7adas.<\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Embora ainda preliminar, a orienta\u00e7\u00e3o indica a futura dire\u00e7\u00e3o regulamentar e permite que as empresas iniciem ajustes antecipados em seus processos de conformidade.<\/p>\n\n<h2 class=\"wp-block-heading\" id=\"h-quality-traceability-and-regulatory-oversight\"><strong>Qualidade, rastreabilidade e supervis\u00e3o regulat\u00f3ria<\/strong><\/h2>\n\n<p class=\"wp-block-paragraph\">As discuss\u00f5es em torno do MDR e do IVDR, combinadas com a implementa\u00e7\u00e3o do QMSR nos Estados Unidos e as novas iniciativas regulat\u00f3rias na China e no setor de cosm\u00e9ticos dos EUA, demonstram que o ambiente regulat\u00f3rio global continua a avan\u00e7ar em dire\u00e7\u00e3o a modelos mais fortes de qualidade, rastreabilidade e supervis\u00e3o.<\/p>\n\n<p class=\"wp-block-paragraph\">Para fabricantes e empresas com atua\u00e7\u00e3o internacional, monitorar essas mudan\u00e7as e integrar a intelig\u00eancia regulat\u00f3ria \u00e0 estrat\u00e9gia de neg\u00f3cios \u00e9 essencial para reduzir riscos, manter a conformidade e sustentar a competitividade em mercados cada vez mais exigentes.<\/p>\n\n<p class=\"wp-block-paragraph\">N\u00e3o importa se o t\u00f3pico \u00e9 MDR e IVDR, tend\u00eancias regulat\u00f3rias de cosm\u00e9ticos ou novas publica\u00e7\u00f5es de autoridades regulat\u00f3rias, o boletim informativo da Sobel \u00e9 onde voc\u00ea encontrar\u00e1 as atualiza\u00e7\u00f5es mais importantes do setor.<\/p>\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/sobelconsult.com\/pt-br\/?popup=810\">Assine gratuitamente o Sobel News Round Up<\/a> e mantenha-se informado sobre os acontecimentos que podem afetar sua empresa nos setores de dispositivos m\u00e9dicos, IVD e cosm\u00e9ticos.<\/p>\n\n<p class=\"wp-block-paragraph\">Para criar uma estrat\u00e9gia regulat\u00f3ria bem-sucedida, voc\u00ea precisa estar preparado para as atualiza\u00e7\u00f5es regulat\u00f3rias globais cont\u00ednuas.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Atualiza\u00e7\u00f5es globais sobre MDR e IVDR, o QMSR nos EUA e novos requisitos regulat\u00f3rios para cosm\u00e9ticos na China e no mercado dos EUA.<\/p>\n","protected":false},"author":12,"featured_media":31528,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_angie_page":false,"page_builder":"","footnotes":"","_members_access_role":[],"_members_access_error":""},"categories":[138],"tags":[529],"market":[501,497],"content_type":[517],"class_list":["post-31533","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-dispositivo-medico","tag-sistemas-da-qualidade-pt-br","market-eua","market-europa","content_type-noticias"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.8 (Yoast SEO v28.1) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Not\u00edcias: MDR e IVDR em revis\u00e3o, QMSR em vigor e muito mais - Sobel<\/title>\n<meta name=\"description\" content=\"Atualiza\u00e7\u00f5es globais sobre MDR e IVDR, o QMSR nos EUA e novos requisitos regulat\u00f3rios para 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