{"id":33310,"date":"2024-11-22T11:34:37","date_gmt":"2024-11-22T10:34:37","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/11\/22\/aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali\/"},"modified":"2024-11-22T12:01:02","modified_gmt":"2024-11-22T11:01:02","slug":"aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/11\/22\/aggiornamento-della-linea-guida-mdcg-2022-5-rev-1-chiarificazioni-sui-prodotti-borderline-tra-dispositivi-medici-e-medicinali\/","title":{"rendered":"Actualizaci\u00f3n de la directriz 2022-5 Rev.1 del MDCG: aclaraci\u00f3n de los productos fronterizos entre productos sanitarios y medicamentos"},"content":{"rendered":"<p style=\"text-align: right;\">22\/11\/2024<\/p>\n<h2>En octubre de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) public\u00f3 la versi\u00f3n actualizada de <strong>la Directriz 2022-5 Rev. 1 del MDCG<\/strong>, titulada <strong>\u00ab<em>Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017\/745 on medical devices<\/em><\/strong>\u00ab.<\/h2>\n<p>Esta directriz es un punto de referencia clave en la Uni\u00f3n Europea para aclarar las distinciones reglamentarias entre productos sanitarios y medicamentos. De hecho, la directriz ayuda al fabricante a clasificar correctamente los <strong>productos fronterizos<\/strong>, es decir, aquellos productos que por su naturaleza no son inmediatamente atribuibles a un sector espec\u00edfico y a los que, por tanto, resulta dif\u00edcil definir qu\u00e9 normativa debe aplicarse. En particular, el documento se refiere a los productos que se encuentran en la frontera entre los productos sanitarios y los medicamentos.<\/p>\n<h2>Principales actualizaciones<\/h2>\n<p>Directriz 2022-5 del MDCG rev. 1 conserva su importancia para ayudar a los fabricantes y reguladores a determinar si un producto debe calificarse como <strong>producto sanitario<\/strong> con arreglo al MDR (UE) 2017\/745, o como <strong>medicamento<\/strong> con arreglo a la Directiva 2001\/83\/CE y al Reglamento (CE) n. 726\/2004.<\/p>\n<p>En la revisi\u00f3n de octubre de 2024, se realizaron <strong>actualizaciones espec\u00edficas de la secci\u00f3n 1.2.6.1<\/strong>, relativa a <strong>los productos destinados a la limpieza, desinfecci\u00f3n o esterilizaci\u00f3n de productos sanitarios<\/strong>.<\/p>\n<p>La revisi\u00f3n aclara que los productos destinados espec\u00edficamente a la <strong>limpieza, desinfecci\u00f3n o esterilizaci\u00f3n<\/strong> de productos sanitarios pueden clasificarse como productos sanitarios, seg\u00fan <strong>el MDR (UE) 2017\/745<\/strong>, si se utilizan como parte de la preparaci\u00f3n de los propios productos. Sin embargo, si el fabricante no los ha destinado <strong>espec\u00edfica y exclusivamente<\/strong> a tales fines (por ejemplo, en el caso de los desinfectantes polivalentes), no est\u00e1n cubiertos por el Reglamento de Productos Sanitarios (MDR). En cambio, estos \u00faltimos est\u00e1n cubiertos por <strong>el Reglamento (UE) 528\/2012<\/strong> <strong>sobre biocidas<\/strong>, que se aplica a los productos con un uso m\u00e1s amplio y no espec\u00edfico.<\/p>\n<p>La distinci\u00f3n se basa en la <strong>acci\u00f3n principal de la sustancia<\/strong> en cuesti\u00f3n y en <strong>la intenci\u00f3n declarada del fabricante.<\/strong> Si la acci\u00f3n es principalmente farmacol\u00f3gica o qu\u00edmica, el producto se considera un medicamento; si, por el contrario, la acci\u00f3n es auxiliar o de apoyo de un producto, se considera un producto sanitario.<br \/>\nEn el caso de los productos de limpieza, desinfecci\u00f3n o esterilizaci\u00f3n, para ser considerados productos sanitarios deben tener <strong>como \u00fanico uso previsto la preparaci\u00f3n de otros productos sanitarios<\/strong>.<\/p>\n<h2>Impacto en las empresas y el sector<\/h2>\n<p>Las actualizaciones tienen implicaciones directas para los fabricantes, ya que aclaran las condiciones en las que un producto se considera un producto sanitario y no un biocida. Esto es especialmente importante para <strong>las empresas que producen detergentes y desinfectantes para usos espec\u00edficos en productos sanitarios<\/strong>.<br \/>\nLa aclaraci\u00f3n aportada por la directriz actualizada contribuir\u00e1 a facilitar el cumplimiento de los requisitos del MDR por parte de los fabricantes.<\/p>\n<p>La versi\u00f3n completa de la gu\u00eda est\u00e1 disponible en la p\u00e1gina web oficial de la Comisi\u00f3n Europea y puede consultarse en el siguiente enlace: <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-5-rev1-guidance-borderline-between-medical-devices-and-medicinal-products-under-regulation-2024-10-29_en\"><strong>MDCG 2022-5 Rev. 1 \u2013 Guidance on borderline between medical devices and medicinal products<\/strong><\/a><strong>.<\/strong><\/p>\n<p>Para m\u00e1s informaci\u00f3n sobre los dispositivos fronterizos basados en sustancias, lea el <a href=\"https:\/\/www.thema-med.com\/2024\/07\/31\/dispositivi-a-base-di-sostanze-come-dimostrare-lancillarita-del-farmaco-secondo-mdr\/\"><strong>art\u00edculo en nuestro Blog<\/strong><\/a><strong>.<\/strong><\/p>\n<p>&gt;&gt;&gt; Thema, en colaboraci\u00f3n con otras empresas del Grupo Complife, ofrece un apoyo integrado y global para la gesti\u00f3n del cumplimiento normativo y de la calidad de los productos fronterizos, en particular cuando apoyan en un medicamento con funci\u00f3n auxiliar. Para m\u00e1s informaci\u00f3n sobre el <strong>Servicio Borderline<\/strong>, dir\u00edjase a: <strong>sales@complifegroup.com.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>22\/11\/2024 En octubre de 2024, el Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG) public\u00f3 la versi\u00f3n actualizada de la Directriz 2022-5  [&#8230;]<\/p>\n","protected":false},"author":115,"featured_media":33296,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-33310","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Actualizaci\u00f3n de la directriz 2022-5 Rev.1 del MDCG: aclaraci\u00f3n de los productos fronterizos entre productos sanitarios y medicamentos - 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