{"id":1108,"date":"2025-06-19T16:11:53","date_gmt":"2025-06-19T15:11:53","guid":{"rendered":"https:\/\/www.md-amconsulting.es\/?p=1108"},"modified":"2025-09-11T11:47:22","modified_gmt":"2025-09-11T10:47:22","slug":"cambios-clave-reglamento-productos-sanitarios","status":"publish","type":"post","link":"https:\/\/www.md-amconsulting.es\/index.php\/2025\/06\/19\/cambios-clave-reglamento-productos-sanitarios\/","title":{"rendered":"Cambios clave en el reglamento de productos sanitarios: gu\u00eda esencial"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" style=\"letter-spacing:1px\">Cambios clave en el reglamento de productos sanitarios<\/h2>\n\n\n\n<p style=\"letter-spacing:1px\">El <strong>Reglamento (UE) 2017\/745 sobre productos sanitarios<\/strong> entr\u00f3 en aplicaci\u00f3n el 26 de mayo de 2021, introduciendo importantes <strong>cambios reglamento productos sanitarios<\/strong> que afectan a la trazabilidad, a los organismos notificados y a los operadores econ\u00f3micos. Hasta 2024, podr\u00e1n convivir en el mercado productos con certificados conforme a la antigua Directiva 93\/42\/CE y al nuevo Reglamento.<\/p>\n\n\n\n<p style=\"letter-spacing:1px\">La Comisi\u00f3n Europea ha se\u00f1alado que ambos certificados ser\u00e1n legalmente v\u00e1lidos y no habr\u00e1 discriminaci\u00f3n en procesos como las licitaciones p\u00fablicas. Asimismo, los certificados de libre venta podr\u00e1n emitirse con base en cualquiera de los dos marcos normativos.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" style=\"letter-spacing:1px\">\u00bfQu\u00e9 implica este cambio normativo?<\/h3>\n\n\n\n<p style=\"letter-spacing:1px\">Aunque el Reglamento mantiene parte de los requisitos de las Directivas anteriores, refuerza varios aspectos clave como:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:1px\">Seguridad durante todo el ciclo de vida del producto<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Requisitos cl\u00ednicos m\u00e1s exigentes<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Nuevas responsabilidades para los agentes de la cadena de suministro<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" style=\"letter-spacing:1px\">Organismos Notificados<\/h3>\n\n\n\n<p style=\"letter-spacing:1px\">Los <strong>Organismos Notificados (ON)<\/strong> se designan conjuntamente entre autoridades nacionales y equipos auditores de la UE. Adem\u00e1s:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:1px\">Ser\u00e1n auditados regularmente por la Comisi\u00f3n y las autoridades nacionales.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Sus funciones pueden ser suspendidas o limitadas si no cumplen los requisitos del reglamento.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" style=\"letter-spacing:1px\">Obligaciones de los operadores econ\u00f3micos<\/h3>\n\n\n\n<p style=\"letter-spacing:1px\">Los nuevos reglamentos establecen obligaciones claras para cada figura de la cadena de suministro:<\/p>\n\n\n\n<h4 class=\"wp-block-heading\" style=\"letter-spacing:1px\">Importadores<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:1px\">Verificar que los productos cumplen los Reglamentos.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Estar registrados en <strong>Eudamed<\/strong>.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Incluir su informaci\u00f3n de contacto en el embalaje o documentaci\u00f3n anexa.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Comunicar al fabricante cualquier reclamaci\u00f3n recibida.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" style=\"letter-spacing:1px\">Distribuidores<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:1px\">Verificar el cumplimiento normativo mediante muestreos.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Comunicar incidentes a fabricantes, representantes autorizados o importadores.<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\" style=\"letter-spacing:1px\">Representantes autorizados<\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li style=\"letter-spacing:1px\">Comprobar que el fabricante ha seguido el proceso adecuado de evaluaci\u00f3n de la conformidad.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Disponer de la documentaci\u00f3n t\u00e9cnica, declaraci\u00f3n de conformidad y certificados.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Apoyar a las autoridades en acciones preventivas y correctivas.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Figurar en el etiquetado.<\/li>\n\n\n\n<li style=\"letter-spacing:1px\">Tener un mandato escrito con el fabricante.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" style=\"letter-spacing:1px\">C\u00f3digo de identificaci\u00f3n \u00fanica (<a href=\"https:\/\/health.ec.europa.eu\/medical-devices-topics-interest\/unique-device-identifier-udi_es\">UDI<\/a>)<\/h3>\n\n\n\n<p style=\"letter-spacing:1px\">El <strong>UDI (Unique Device Identifier)<\/strong> es un c\u00f3digo alfanum\u00e9rico que permite la identificaci\u00f3n inequ\u00edvoca de los productos en el mercado. Es obligatorio para todos los productos sanitarios, excepto los \u201ca medida\u201d y los destinados a investigaci\u00f3n.<\/p>\n\n\n\n<p style=\"letter-spacing:1px\">Si tiene cualquier duda al respecto, \u00a1no dude en <a href=\"https:\/\/www.md-amconsulting.es\/index.php\/pagina-de-contacto\/\">consultarnos<\/a>!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Cambios clave en el reglamento de productos sanitarios El Reglamento (UE) 2017\/745 sobre productos sanitarios entr\u00f3 en aplicaci\u00f3n el 26 de mayo de 2021, introduciendo importantes cambios reglamento productos sanitarios que afectan a la trazabilidad, a los organismos notificados y a los operadores econ\u00f3micos. Hasta 2024, podr\u00e1n convivir en el mercado productos con certificados conforme [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":786,"comment_status":"open","ping_status":"open","sticky":false,"template":"page-blog","format":"standard","meta":{"saved_in_kubio":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[50],"tags":[12,35,69,18,59,28],"class_list":["post-1108","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-consultoria","tag-diagnostico-in-vitro","tag-formacion","tag-marcado-ce","tag-mdr","tag-poscomercializacion"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Cambios clave en el reglamento de productos sanitarios: - 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