{"id":32718,"date":"2024-06-21T10:00:09","date_gmt":"2024-06-21T08:00:09","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/06\/21\/ema-aggiornata-la-linea-guida-questions-and-answers-sui-prodotti-combinati-farmaco-dispositivo\/"},"modified":"2024-06-21T10:12:42","modified_gmt":"2024-06-21T08:12:42","slug":"ema-aggiornata-la-linea-guida-questions-and-answers-sui-prodotti-combinati-farmaco-dispositivo","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/06\/21\/ema-aggiornata-la-linea-guida-questions-and-answers-sui-prodotti-combinati-farmaco-dispositivo\/","title":{"rendered":"EMA: gu\u00eda actualizada de preguntas y respuestas sobre combinaciones de medicamentos y dispositivos"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>En mayo de 2024, la Agencia Europea de Medicamentos <strong>(EMA)<\/strong>, junto con el Grupo de Coordinaci\u00f3n de Procedimientos Descentralizados y de Reconocimiento Mutuo <strong>(CMDh)<\/strong>, public\u00f3 la <strong>cuarta revisi\u00f3n<\/strong> de la <strong>gu\u00eda <\/strong>en formato de <strong>preguntas y respuestas<\/strong> sobre <strong>combinaciones de medicamentos y productos sanitarios <\/strong>(tanto DM como de diagn\u00f3stico in vitro) para fabricantes que solicitan autorizaci\u00f3n de acceso al mercado y Organismos Notificados acreditados.<\/h2>\n<p>El documento, que se basa en la experiencia y en casos reales, transmite <strong>informaci\u00f3n pr\u00e1ctica <\/strong>de gran utilidad, teniendo en cuenta que muchos de los dispositivos m\u00e1s innovadores en producci\u00f3n incluyen una parte de medicamento (o sustancia) adem\u00e1s del propio dispositivo y est\u00e1n <strong>regulados en el marco farmac\u00e9utico y\/o de productos sanitarios<\/strong>, en funci\u00f3n del modo de acci\u00f3n principal del producto, en un contexto jur\u00eddico que no siempre es f\u00e1cil de interpretar.<\/p>\n<p>La gu\u00eda pretende servir de apoyo al Reglamento sobre productos sanitarios MDR (UE) 2017\/745 y al Reglamento sobre productos para diagn\u00f3stico in vitro IVDR (UE) 2017\/746.<\/p>\n<p><strong>Objetos principales de las preguntas y respuestas<\/strong><\/p>\n<p>En concreto, el conjunto de preguntas que componen la gu\u00eda se refieren a los procedimientos de gesti\u00f3n a lo largo del ciclo de vida del producto y la solicitud de autorizaci\u00f3n para:<\/p>\n<ul>\n<li>productos sanitarios y medicamentos que constituyen un producto integral con un medicamento (productos combinados integrales), como las jeringuillas precargadas;<\/li>\n<li>medicamentos que incluyen un producto sanitario (co-envasado) y etiquetado en su envase;<\/li>\n<li>los productos compuestos por sustancias medicinales que, como parte integrante del producto sanitario, desempe\u00f1an una funci\u00f3n auxiliar, accesoria, es decir, de apoyo al buen funcionamiento del producto;<\/li>\n<li>procedimientos de consulta para acompa\u00f1ar diagn\u00f3sticos, pruebas diagn\u00f3sticas esenciales para el uso correcto de un medicamento espec\u00edfico.<\/li>\n<\/ul>\n<p>El documento presenta <strong>cambios significativos<\/strong> <strong>respecto a la versi\u00f3n anterior, publicada en noviembre de 2023<\/strong>, en particular porque contiene m\u00e1s secciones.<\/p>\n<p>Por nombrar algunas, la <strong>nueva<\/strong> <strong>pregunta 1.3. <\/strong>especifica c\u00f3mo obtener asesoramiento sobre la clasificaci\u00f3n de los productos combinados medicamento-producto, en particular para los <strong>productos<\/strong> <strong>fronterizos<\/strong>, que son aquellos para los que no est\u00e1 claro si el contexto legal de referencia que debe aplicarse es el de los productos sanitarios o el de los medicamentos. En pocas palabras, la decisi\u00f3n sobre la clasificaci\u00f3n de los productos corresponde a las autoridades nacionales responsables de los medicamentos y\/o productos sanitarios.<\/p>\n<p>\u00bfPueden los solicitantes de autorizaci\u00f3n presentar la declaraci\u00f3n de conformidad parcial del organismo notificado con los requisitos generales de seguridad y funcionamiento (GSPR)? \u00bfQu\u00e9 peso tiene el dictamen del organismo notificado?\u00a0 Se trata, en definitiva, de la <strong>pregunta 2.4.<\/strong>, a la que se responde negativamente.<strong>\u00a0 <\/strong>De hecho, la gu\u00eda establece que la opini\u00f3n de un organismo notificado no puede aceptarse, explicando los motivos.<\/p>\n<p><strong>\u00a0<\/strong>La <strong>pregunta 2.7 <\/strong>trata de los cambios menores introducidos en los <strong>productos de<\/strong> <strong>combinaci\u00f3n<\/strong> <strong>integral<\/strong> <strong>de medicamento y dispositivo<\/strong>, combinaci\u00f3n de medicamento y dispositivo (DDC): como con cualquier otro cambio, el titular de la autorizaci\u00f3n debe determinar si el cambio afecta significativamente a la calidad y eficacia del producto y, en caso afirmativo, solicitar una modificaci\u00f3n; en la respuesta se incluyen numerosas ideas y facetas, que deben leerse con atenci\u00f3n.<\/p>\n<p>En la <a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf\"><strong>gu\u00eda<\/strong><\/a> puede profundizar en todas las preguntas y respuestas.<\/p>\n<p>&gt;&gt;&gt; THEMA, en asociaci\u00f3n con otras empresas del Grupo Complife, puede ser su <strong>aliado estrat\u00e9gico <\/strong>en la demostraci\u00f3n de la conformidad de los productos sanitarios combinados f\u00e1rmaco-dispositivo m\u00e9dico, especialmente los <strong>productos sanitarios<\/strong> <strong>fronterizos<\/strong> respaldados por un <strong>f\u00e1rmaco con funci\u00f3n auxiliar<\/strong>. Para m\u00e1s informaci\u00f3n<a href=\"mailto:sales@thema-med.com\">: sales@thema-med.com<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Fuente<\/strong><strong>: <\/strong><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/regulatory-procedural-guideline\/questions-answers-implementation-medical-devices-vitro-diagnostic-medical-devices-regulations-eu-2017-745-eu-2017-746_en.pdf\">Questions &amp; Answers on the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (europa.eu)<\/a><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/medical-devices-new-guidance-industry-notified-bodies\">https:\/\/www.ema.europa.eu\/en\/news\/medical-devices-new-guidance-industry-notified-bodies<\/a><br \/>\n<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf\">QWP-BWP Guideline on medicinal products used with a medical device (europa.eu)<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32698,"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-32718","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>EMA: gu\u00eda actualizada de preguntas y respuestas sobre combinaciones de medicamentos y dispositivos<\/title>\n<meta name=\"description\" content=\"Il Medical Device Coordination Group (MDCG) ha aggiornato la linea guida MDCG 2024-2 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