{"id":34887,"date":"2025-11-25T14:25:11","date_gmt":"2025-11-25T13:25:11","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34887"},"modified":"2025-11-25T17:10:45","modified_gmt":"2025-11-25T16:10:45","slug":"espana-completa-la-adaptacion-al-ivdr-con-el-real-decreto-942-2025","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/11\/25\/espana-completa-la-adaptacion-al-ivdr-con-el-real-decreto-942-2025\/","title":{"rendered":"Espa\u00f1a Completa la Adaptaci\u00f3n al IVDR con el Real Decreto 942\/2025"},"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-blend:overlay;--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\"><p style=\"text-align: right;\"><strong><em>Traducido con IA<\/em><\/strong><\/p>\n<p>El 23 de octubre de 2025 se public\u00f3 en el <em>Bolet\u00edn Oficial del Estado<\/em> (BOE) el <strong>Real Decreto espa\u00f1ol n.\u00ba 942\/2025<\/strong> que <strong>completa la adaptaci\u00f3n<\/strong> de la legislaci\u00f3n nacional espa\u00f1ola al <strong>Reglamento europeo IVDR (UE) 2017\/746<\/strong> relativo a los Productos Sanitarios para Diagn\u00f3stico <em>In Vitro<\/em>. El Decreto entr\u00f3 en vigor el d\u00eda despu\u00e9s de su publicaci\u00f3n, es decir, el <strong>24 de octubre de 2025<\/strong>.<\/p>\n<p>Con la promulgaci\u00f3n del Decreto 942\/2025, Espa\u00f1a refuerza el marco normativo preexistente, garantizando que las pr\u00e1cticas internas y la puesta a disposici\u00f3n de los productos IVD est\u00e9n plenamente alineadas con los <strong>requisitos europeos.<\/strong> El Decreto a\u00f1ade adem\u00e1s algunos <strong>requisitos nacionales espec\u00edficos<\/strong> al Reglamento IVDR.<\/p>\n<p>A continuaci\u00f3n, se detallan los puntos clave.<\/p>\n<h3><strong>Mayores Obligaciones para los Productos IVD de \u201cFabricaci\u00f3n Interna\u201d (<em>In-House<\/em>)<\/strong><\/h3>\n<p>El Decreto establece requisitos espec\u00edficos para los <strong>IVD de \u201cFabricaci\u00f3n Interna\u201d (<em>In-House<\/em>) &#8211; <\/strong>es decir, fabricados y utilizados dentro de la misma instituci\u00f3n sanitaria (como los <strong>Laboratorios Cl\u00ednicos<\/strong>) &#8211; equiparando su regulaci\u00f3n a la de los fabricantes de IVD (Art\u00edculo 7). El objetivo es someter a los productos IVD no cubiertos por certificaci\u00f3n externa a los est\u00e1ndares de calidad m\u00e1s elevados:<\/p>\n<ul>\n<li><strong>Obligatoriedad de la ISO 15189:<\/strong> los Centros deben obtener la acreditaci\u00f3n conforme a la norma internacional <strong>ISO 15189<\/strong> (Calidad y competencia de los laboratorios cl\u00ednicos). Por primera vez, la acreditaci\u00f3n de la ISO 15189 no solo es recomendada, sino que se convierte en <strong>obligatoria (legalmente vinculante)<\/strong> y es requerida para aquellos Centros que producen y utilizan IVD dentro de su propia estructura sanitaria.<\/li>\n<\/ul>\n<p>Se prev\u00e9n plazos escalonados en funci\u00f3n de la clase de riesgo del producto utilizado:<\/p>\n<ul>\n<li style=\"list-style-type: none;\">\n<ul>\n<li><strong>2027:<\/strong> Aplicaci\u00f3n de la obligaci\u00f3n para la <strong>Clase D<\/strong> (riesgo m\u00e1s alto).<\/li>\n<li><strong>2032:<\/strong> Aplicaci\u00f3n de la obligaci\u00f3n para las <strong>Clases A\/B<\/strong> (riesgo m\u00e1s bajo).<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>Este requisito est\u00e1 espec\u00edficamente ligado a la <strong>prestaci\u00f3n de servicios de diagn\u00f3stico <em>in vitro<\/em><\/strong> y a la <strong>fabricaci\u00f3n de productos para uso interno<\/strong>, garantizando que incluso los IVD no certificados por terceros (Organismos Notificados) est\u00e9n sujetos a un riguroso sistema de gesti\u00f3n de la calidad.<\/p>\n<ul>\n<li><strong>Obligaciones de Registro y Persona Responsable:<\/strong> la obligaci\u00f3n de designar a una Persona Responsable del Cumplimiento Normativo (PRRC), ya prevista por el Reglamento IVDR (UE) 2017\/745 para los fabricantes de productos sanitarios, con el Real Decreto se <strong>extiende y formaliza<\/strong> <strong>tambi\u00e9n para los laboratorios que producen <em>In-House<\/em><\/strong>. <strong><br \/>\n<\/strong>Dichos centros, considerados ahora como fabricantes a efectos regulatorios, deber\u00e1n <strong>notificar el inicio de la actividad de fabricaci\u00f3n a la AEMPS<\/strong> (Agencia Espa\u00f1ola de Medicamentos y Productos Sanitarios) y nombrar formalmente a una <strong>Persona Responsable<\/strong> de la conformidad con los requisitos establecidos.<\/li>\n<\/ul>\n<h3><strong>Regulaci\u00f3n M\u00e1s Estricta para las Pruebas Gen\u00e9ticas<\/strong><\/h3>\n<p>Para proteger la salud y los derechos de los pacientes, el Real Decreto interviene con medidas espec\u00edficas para las pruebas gen\u00e9ticas:<\/p>\n<ul>\n<li><strong>Consentimiento Informado:<\/strong> se imponen reglas que aseguren que el paciente, antes de someterse a una prueba gen\u00e9tica, reciba <strong>informaci\u00f3n clara y completa<\/strong> por razones \u00e9ticas y legales, sobre la finalidad de la prueba, su irreversibilidad y su impacto a largo plazo (por ejemplo, los resultados pueden tener consecuencias significativas en las opciones reproductivas, en las oportunidades laborales o en el acceso a los seguros).<\/li>\n<li><strong>Asesoramiento Gen\u00e9tico Obligatorio:<\/strong> los centros que ofrecen pruebas gen\u00e9ticas est\u00e1n ahora obligados a proporcionar a los pacientes un<strong> servicio de asesoramiento gen\u00e9tico cualificado<\/strong>. El Art\u00edculo 34.2 especifica que los centros deber\u00e1n garantizar que el paciente reciba asesoramiento gen\u00e9tico adecuado antes y despu\u00e9s de la comunicaci\u00f3n del resultado.<\/li>\n<\/ul>\n<h3><strong>Obligaci\u00f3n de Registro Nacional para los Operadores Econ\u00f3micos<\/strong><\/h3>\n<p>Para garantizar la trazabilidad, en ausencia de la plena operatividad de EUDAMED, el Decreto prev\u00e9 la obligaci\u00f3n de inscripci\u00f3n en el <strong>Registro de Comercializaci\u00f3n<\/strong> <strong>gestionado por la AEMPS<\/strong> tambi\u00e9n para los <strong>Importadores y Distribuidores<\/strong>, adem\u00e1s de los fabricantes. Este registro nacional es esencial para poder introducir legalmente los productos en el mercado ib\u00e9rico.<\/p>\n<p>\ud83d\udc49 Con sus <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">servicios de consultor\u00eda estrat\u00e9gico-regulatoria<\/a>, Thema puede acompa\u00f1ar a los productos sanitarios y productos sanitarios para diagn\u00f3stico <em>in vitro<\/em> en el mercado espa\u00f1ol en plena conformidad, garantizando que los sistemas de gesti\u00f3n de la calidad de importadores, fabricantes extranjeros y fabricantes <em>in-house<\/em> cumplan plenamente con los requisitos.<\/p>\n<p><strong>FUENTE:<\/strong> <a href=\"https:\/\/www.boe.es\/diario_boe\/txt.php?id=BOE-A-2025-21298\">https:\/\/www.boe.es\/diario_boe\/txt.php?id=BOE-A-2025-21298<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":34904,"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-34887","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 - 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