{"id":7994,"date":"2025-02-26T15:49:15","date_gmt":"2025-02-26T07:49:15","guid":{"rendered":"https:\/\/regask.com\/?p=7994"},"modified":"2025-02-28T18:07:26","modified_gmt":"2025-02-28T10:07:26","slug":"francia-ansm-exencion-de-marca-ce","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/france-ansm-ce-mark-exemption\/","title":{"rendered":"ANSM (Francia) aclara el proceso de exenci\u00f3n de la marca CE para M..."},"content":{"rendered":"<p>En <strong>27 de enero de 2025<\/strong>, el <strong>Agencia Nacional de Seguridad de Medicamentos y Productos Sanitarios (ANSM)<\/strong> En Francia se public\u00f3 una actualizaci\u00f3n clave sobre el proceso para obtener <strong>Exenciones de la marca CE<\/strong> para dispositivos m\u00e9dicos. Esta aclaraci\u00f3n reglamentaria describe las condiciones espec\u00edficas en las que los fabricantes pueden solicitar la aprobaci\u00f3n para comercializar dispositivos m\u00e9dicos en Francia. <strong>Sin certificaci\u00f3n CE<\/strong>, que normalmente se requiere para confirmar el cumplimiento de <strong>Normas de seguridad y rendimiento de la UE<\/strong>.<\/p>\n<p>La ANSM destaca que estas exenciones se conceden <strong>S\u00f3lo en circunstancias excepcionales<\/strong>, principalmente para salvaguardar <strong>Salud p\u00fablica y seguridad del paciente<\/strong>, de acuerdo con <strong>Art\u00edculo 59 del Reglamento (UE) 2017\/745<\/strong>.<\/p>\n<p>Las excepciones a la marca CE se limitan estrictamente a situaciones en las que existe una necesidad imperiosa de salud p\u00fablica o una preocupaci\u00f3n por la seguridad del paciente. Para cumplir los requisitos, los fabricantes deben demostrar <strong>beneficio significativo para el paciente<\/strong>, respaldado por datos de seguridad y rendimiento, y demostrar que <strong>No hay productos alternativos<\/strong> Est\u00e1n disponibles en el mercado.<\/p>\n<p>En la actualizaci\u00f3n se describen dos tipos de exenciones. <strong>Exenciones individuales<\/strong> se aplican a pacientes espec\u00edficos en funci\u00f3n de necesidades m\u00e9dicas urgentes, mientras que <strong>exenciones globales<\/strong> abarcan casos m\u00e1s amplios pero permanecen <strong>De alcance y tiempo limitados<\/strong>Los profesionales sanitarios que utilicen dispositivos al amparo de una excepci\u00f3n deben informar a los pacientes sobre la falta de marcado CE, obtener su consentimiento expl\u00edcito y notificar cualquier incidente o riesgo asociado al uso del dispositivo.<\/p>\n<p>La ANSM evaluar\u00e1 las solicitudes <strong>caso por caso<\/strong>, garantizando que se mantengan las exenciones <strong>excepcional<\/strong> y no pasar por alto <strong>v\u00edas regulatorias est\u00e1ndar<\/strong>, incluidas las investigaciones cl\u00ednicas.<\/p>\n<p>Los fabricantes y proveedores de atenci\u00f3n m\u00e9dica involucrados en el suministro o uso de dispositivos m\u00e9dicos en Francia deben revisar cuidadosamente la gu\u00eda actualizada de la ANSM para asegurarse <strong>cumplimiento<\/strong> y <strong>documentaci\u00f3n adecuada<\/strong> cuando se solicita una derogaci\u00f3n.<\/p>\n<p>Para obtener detalles completos, consulte la publicaci\u00f3n oficial de ANSM en <strong>Exenciones de la marca CE<\/strong>.<\/p>","protected":false},"excerpt":{"rendered":"<p>El 27 de enero de 2025, la Agencia Nacional de Seguridad de Medicamentos y Productos Sanitarios (ANSM) de Francia emiti\u00f3 una actualizaci\u00f3n clave sobre el proceso de obtenci\u00f3n de exenciones del marcado CE para dispositivos m\u00e9dicos. Esta aclaraci\u00f3n regulatoria describe las condiciones espec\u00edficas bajo las cuales los fabricantes pueden solicitar la aprobaci\u00f3n para comercializar dispositivos m\u00e9dicos en Francia sin la certificaci\u00f3n CE, lo cual es\u2026<\/p>","protected":false},"author":30,"featured_media":8074,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[509,39],"tags":[165,602],"class_list":["post-7994","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-france-regulations","category-medical-devices-insights","tag-public-health","tag-import-and-export-regs"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>France ANSM Updates CE Mark Exemption Process | RegASK<\/title>\n<meta name=\"description\" content=\"France\u2019s ANSM clarifies CE mark exemption rules for medical devices, ensuring compliance &amp; patient safety. 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