{"id":9814,"date":"2026-01-16T12:12:28","date_gmt":"2026-01-16T12:12:28","guid":{"rendered":"https:\/\/mdxcro.com\/mdr-and-ivdr-targeted-revision-2026\/"},"modified":"2026-03-02T16:43:25","modified_gmt":"2026-03-02T16:43:25","slug":"mdr-and-ivdr-targeted-revision-2026","status":"publish","type":"post","link":"https:\/\/mdxcro.com\/es\/mdr-and-ivdr-targeted-revision-2026\/","title":{"rendered":"Revisi\u00f3n espec\u00edfica del MDR y el IVDR"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\">Lo que los fabricantes de la UE deben saber en 2026<\/h2>\n\n<p>Si desarrolla, lanza o mantiene productos sanitarios o IVD en la UE, la <strong>revisi\u00f3n espec\u00edfica del MDR\/IVDR<\/strong> es la actualizaci\u00f3n normativa m\u00e1s relevante desde 2017. El <strong>16 de diciembre de 2025<\/strong>, la Comisi\u00f3n Europea present\u00f3 una propuesta para <strong>simplificar<\/strong> y <strong>agilizar<\/strong> el MDR y el IVDR, reduciendo la carga administrativa y <strong>manteniendo intactas las normas de seguridad<\/strong>. <\/p>\n\n<p>Por nuestra parte<strong>, con m\u00e1s de 40 consultores<\/strong> que apoyan a fabricantes en <strong>el Reino Unido, EE. UU., Espa\u00f1a, B\u00e9lgica, Portugal y el conjunto de la UE<\/strong>, ya hemos mapeado el impacto pr\u00e1ctico por funci\u00f3n, clase y cartera. Nuestro equipo de expertos analiz\u00f3 la revisi\u00f3n y redact\u00f3 este art\u00edculo, con pasos de acci\u00f3n que puede empezar este trimestre.   <\/p>\n\n<div id=\"download\" class=\"wp-block-group has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-b896e0b1abf978b1b2b7f7b89cfacab1 has-global-padding is-layout-constrained wp-container-core-group-is-layout-50133c3e wp-block-group-is-layout-constrained\" style=\"min-height:30%;margin-top:var(--wp--preset--spacing--small);margin-bottom:var(--wp--preset--spacing--small);padding-top:var(--wp--preset--spacing--large);padding-right:16%;padding-bottom:var(--wp--preset--spacing--large);padding-left:16%\">\n<h2 class=\"wp-block-heading has-text-align-center\">Descargue el an\u00e1lisis normativo completo<\/h2>\n\n\n\n<p class=\"has-text-align-center\">\u00bfQuiere el <strong>desglose art\u00edculo por art\u00edculo<\/strong>, plantillas (di\u00e1logo estructurado con el ON, cadencia de PSUR, calendario de Basic UDI-DI) y <strong>listas de verificaci\u00f3n por funci\u00f3n<\/strong>?<\/p>\n\n\n<style id=\"wpforms-css-vars-9201-block-03907a8f-53aa-4df3-8544-33cc3f88a00f\">\n\t\t\t\t#wpforms-9201.wpforms-block-03907a8f-53aa-4df3-8544-33cc3f88a00f {\n\t\t\t\t--wpforms-label-color: #c5c5c5;\n--wpforms-label-sublabel-color: #8e8e8e;\n--wpforms-field-border-color: #737373;\n--wpforms-field-border-color-spare: #737373;\n--wpforms-field-text-color: #484848;\n--wpforms-field-menu-color: #c9c9c9;\n--wpforms-button-background-color: #f7f7f7;\n--wpforms-button-text-color: #0000F0;\n--wpforms-background-color: #00000000;\n--wpforms-label-error-color: #df5858;\n--wpforms-container-padding: 3px;\n--wpforms-field-size-input-height: 43px;\n--wpforms-field-size-input-spacing: 15px;\n--wpforms-field-size-font-size: 16px;\n--wpforms-field-size-line-height: 19px;\n--wpforms-field-size-padding-h: 14px;\n--wpforms-field-size-checkbox-size: 16px;\n--wpforms-field-size-sublabel-spacing: 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>\n\t\t<\/div>\n\t\t<div id=\"wpforms-9201-field_4-container\" class=\"wpforms-field wpforms-field-hidden\" data-field-id=\"4\"><input type=\"hidden\" id=\"wpforms-9201-field_4\" name=\"wpforms[fields][4]\"><\/div><div id=\"wpforms-9201-field_6-container\" class=\"wpforms-field wpforms-field-hidden\" data-field-id=\"6\"><input type=\"hidden\" id=\"wpforms-9201-field_6\" name=\"wpforms[fields][6]\"><\/div><div id=\"wpforms-9201-field_9-container\" class=\"wpforms-field wpforms-field-hidden\" data-field-id=\"9\"><input type=\"hidden\" id=\"wpforms-9201-field_9\" name=\"wpforms[fields][9]\"><\/div><div id=\"wpforms-9201-field_15-container\" class=\"wpforms-field wpforms-field-hidden\" data-field-id=\"15\"><input type=\"hidden\" id=\"wpforms-9201-field_15\" name=\"wpforms[fields][15]\" value=\"MDR_IVDR_TargetedRevision\"><\/div><div id=\"wpforms-9201-field_7-container\" class=\"wpforms-field wpforms-field-hidden\" data-field-id=\"7\"><input type=\"hidden\" id=\"wpforms-9201-field_7\" 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wpforms-is-recaptcha-type-v3\" ><input type=\"hidden\" name=\"wpforms[recaptcha]\" value=\"\"><\/div><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"9201\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/mdxcro.com\/es\/wp-json\/wp\/v2\/posts\/9814\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-9201\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Download regulatory analysis\" aria-live=\"assertive\" value=\"wpforms-submit\">Download regulatory analysis<\/button><\/div><\/form><\/div>  <!-- .wpforms-container -->\n\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\"><\/div>\n<\/div>\n\n<h2 class=\"wp-block-heading\">Visi\u00f3n general: por qu\u00e9 la UE propuso una revisi\u00f3n espec\u00edfica<\/h2>\n\n<p>El objetivo de la Comisi\u00f3n es sencillo: <strong>reducir la carga, mejorar la previsibilidad y proteger la innovaci\u00f3n<\/strong>, sin rebajar los requisitos de seguridad o rendimiento. La medida responde a cuellos de botella estructurales (capacidad de los ON, pr\u00e1cticas desiguales y plazos de certificaci\u00f3n) que han tensionado a las pymes y limitado la disponibilidad de productos. <\/p>\n\n<blockquote class=\"wp-block-quote has-black-color has-white-frost-background-color has-text-color has-background has-regular-font-size is-layout-flow wp-block-quote-is-layout-flow\" style=\"margin-top:var(--wp--preset--spacing--small);margin-bottom:var(--wp--preset--spacing--small);padding-right:var(--wp--preset--spacing--xlarge);padding-left:var(--wp--preset--spacing--xlarge)\">\n<p class=\"has-medium-font-size\" style=\"margin-top:var(--wp--preset--spacing--tiny);margin-right:0;margin-bottom:var(--wp--preset--spacing--tiny);margin-left:0;padding-top:var(--wp--preset--spacing--tiny);padding-right:var(--wp--preset--spacing--regular);padding-bottom:var(--wp--preset--spacing--tiny);padding-left:var(--wp--preset--spacing--regular)\"><strong><mark style=\"background-color:#F3F8FB\" class=\"has-inline-color has-blue-color\">Perspectiva del equipo<\/mark><\/strong><br\/>En proyectos recientes con ON para fabricantes del Reino Unido y EE. UU. que buscan el marcado CE en la UE, hemos observado que una <strong>interacci\u00f3n temprana y estructurada con el ON<\/strong> elimina ciclos de revisi\u00f3n evitables y reduce el time-to-decision, especialmente en carteras complejas.  <\/p>\n<\/blockquote>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Qu\u00e9 cambia realmente (y qu\u00e9 no)<\/mark><\/h2>\n\n<p>La propuesta <strong>mantiene los fundamentos de seguridad del MDR\/IVDR<\/strong>, pero cambia <em>c\u00f3mo<\/em> se aplican los procesos, de forma m\u00e1s proporcionada y digital por defecto. \u00c1reas clave: <\/p>\n\n<h3 class=\"wp-block-heading\">PRRC, validez de los certificados y revisiones basadas en el riesgo<\/h3>\n\n<ul class=\"wp-block-list\">\n<li><strong>PRRC<\/strong>: simplifica los requisitos de cualificaci\u00f3n; las pymes que utilicen un PRRC externo ya no necesitan que est\u00e9 disponible \u201cde forma permanente y continua\u201d, sino simplemente <strong>disponible<\/strong>.<\/li>\n\n\n\n<li><strong>Validez del certificado<\/strong>: se elimina el ciclo fijo de 5 a\u00f1os. Se esperan <strong>revisiones peri\u00f3dicas basadas en el riesgo<\/strong> en lugar de plazos r\u00edgidos de recertificaci\u00f3n. <\/li>\n<\/ul>\n\n<blockquote class=\"wp-block-quote has-black-color has-white-frost-background-color has-text-color has-background has-link-color has-regular-font-size wp-elements-6007271640b6e182455face0e1e36e00 is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-medium-font-size\" style=\"margin-top:var(--wp--preset--spacing--tiny);margin-right:0;margin-bottom:var(--wp--preset--spacing--tiny);margin-left:0;padding-top:var(--wp--preset--spacing--tiny);padding-right:var(--wp--preset--spacing--regular);padding-bottom:var(--wp--preset--spacing--tiny);padding-left:var(--wp--preset--spacing--regular)\"><strong><mark style=\"background-color:#F3F8FB\" class=\"has-inline-color has-blue-color\">Perspectiva del equipo<\/mark><\/strong><br\/>En recertificaciones multisede, pasar a <strong>revisiones basadas en el riesgo<\/strong> permite a RA\/QA centrarse en <em>se\u00f1ales<\/em> en lugar de hitos del calendario; nuestros clientes esperan una reducci\u00f3n significativa del retrabajo relacionado con los PSUR tras secuenciar las actualizaciones con los hallazgos de PMS.  <\/p>\n<\/blockquote>\n\n<h3 class=\"wp-block-heading\">PSUR y SSCP\/SSP: informes m\u00e1s ligeros y guiados por el riesgo<\/h3>\n\n<ul class=\"wp-block-list\">\n<li><strong>PSUR<\/strong>: Clase IIb\/III (actualizaci\u00f3n en el a\u00f1o 1 y <strong>cada 2 a\u00f1os<\/strong> despu\u00e9s; Clase IIa) <strong>solo cuando sea necesario<\/strong> en funci\u00f3n del PMS. Los ON revisan los PSUR de las clases de alto riesgo durante la vigilancia. <\/li>\n\n\n\n<li><strong>SSCP\/SSP<\/strong>: alcance limitado a productos bajo <strong>evaluaci\u00f3n sistem\u00e1tica de la DT<\/strong>; <strong>sin validaci\u00f3n separada del ON<\/strong>.<\/li>\n<\/ul>\n\n<h3 class=\"wp-block-heading\">Ajustes de clasificaci\u00f3n: software, instrumentos reutilizables y m\u00e1s<\/h3>\n\n<p>Se esperan ajustes espec\u00edficos de las reglas que reduzcan la clase de riesgo para determinadas categor\u00edas (p. ej., algunos <strong>instrumentos quir\u00fargicos reutilizables<\/strong>, <strong>accesorios de implantables activos<\/strong>, <strong>software<\/strong>), con expectativas de evidencia proporcionales; los detalles se concretar\u00e1n a trav\u00e9s del proceso legislativo.<\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Enfoque IVDR<\/mark>: productos de fabricaci\u00f3n interna, estudios e impactos en las clases C\/D<\/h2>\n\n<ul class=\"wp-block-list\">\n<li><strong>Productos de fabricaci\u00f3n interna (art\u00edculo 5(5))<\/strong>: m\u00e1s flexibilidad, incluida la posibilidad de <strong>transferir<\/strong> productos de fabricaci\u00f3n interna cuando la salud p\u00fablica lo justifique; eliminaci\u00f3n de la condici\u00f3n de \u201cno equivalente en el mercado\u201d; los laboratorios centrales para ensayos cl\u00ednicos quedan cubiertos por la exenci\u00f3n de fabricaci\u00f3n interna.<\/li>\n\n\n\n<li><strong>Estudios de rendimiento<\/strong>: las <strong>extracciones de sangre rutinarias<\/strong> ya no necesitan autorizaci\u00f3n previa; los estudios de diagn\u00f3stico complementario con <strong>muestras sobrantes<\/strong> eliminan los requisitos de notificaci\u00f3n.<\/li>\n<\/ul>\n\n<blockquote class=\"wp-block-quote has-black-color has-white-frost-background-color has-text-color has-background has-link-color has-regular-font-size wp-elements-be8632405dcac038f073ceae1d1e5f99 is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-medium-font-size\" style=\"margin-top:var(--wp--preset--spacing--tiny);margin-right:0;margin-bottom:var(--wp--preset--spacing--tiny);margin-left:0;padding-top:var(--wp--preset--spacing--tiny);padding-right:var(--wp--preset--spacing--regular);padding-bottom:var(--wp--preset--spacing--tiny);padding-left:var(--wp--preset--spacing--regular)\"><mark style=\"background-color:#F3F8FB\" class=\"has-inline-color has-blue-color\"><strong>Perspectiva del equipo<\/strong><\/mark><br\/>El <strong>asesoramiento temprano de paneles de expertos<\/strong> para IVD de clase C\/D ha evitado retrabajos costosos en m\u00faltiples expedientes. La propuesta formaliza un aporte cient\u00edfico m\u00e1s temprano y r\u00e1pido para poder aprovecharlo. <\/p>\n<\/blockquote>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\"><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-blue-color\">Acceso al mercado m\u00e1s r\u00e1pido y m\u00e1s claro<\/mark><\/h2>\n\n<h3 class=\"wp-block-heading\">Di\u00e1logo estructurado con los Organismos Notificados (y planes de control de cambios)<\/h3>\n\n<p>La propuesta crea una <strong>base jur\u00eddica formal<\/strong> para el <strong>di\u00e1logo estructurado<\/strong> antes y despu\u00e9s de la presentaci\u00f3n, adem\u00e1s de <strong>planes de control de cambios preacordados<\/strong> para reducir sorpresas. Tambi\u00e9n distingue los cambios que requieren <strong>notificaci\u00f3n<\/strong>, <strong>aprobaci\u00f3n<\/strong> o <strong>ninguna<\/strong>. <\/p>\n\n<h3 class=\"wp-block-heading\">Productos innovadores y hu\u00e9rfanos: prioridad y revisiones continuas<\/h3>\n\n<p>Nuevos art\u00edculos definen los criterios de <strong>innovador<\/strong> y <strong>hu\u00e9rfano<\/strong> con evaluaci\u00f3n de la conformidad <strong>prioritaria<\/strong>\/<strong>continua<\/strong> y acceso a expertos; los productos hu\u00e9rfanos heredados podr\u00e1n continuar m\u00e1s all\u00e1 de la transici\u00f3n bajo condiciones.<\/p>\n\n<h3 class=\"wp-block-heading\">Entornos controlados regulatorios para tecnolog\u00edas emergentes<\/h3>\n\n<p>Los <strong>entornos controlados<\/strong> a nivel de la UE o de los Estados miembros permitir\u00e1n pruebas supervisadas y generaci\u00f3n de datos para tecnolog\u00edas novedosas, acelerando la reducci\u00f3n de riesgos y manteniendo las salvaguardas.<\/p>\n\n<blockquote class=\"wp-block-quote has-black-color has-white-frost-background-color has-text-color has-background has-link-color has-regular-font-size wp-elements-62e30ef29544945a47b98e6f0da0da81 is-layout-flow wp-block-quote-is-layout-flow\">\n<p class=\"has-medium-font-size\" style=\"margin-top:var(--wp--preset--spacing--tiny);margin-right:0;margin-bottom:var(--wp--preset--spacing--tiny);margin-left:0;padding-top:var(--wp--preset--spacing--tiny);padding-right:var(--wp--preset--spacing--regular);padding-bottom:var(--wp--preset--spacing--tiny);padding-left:var(--wp--preset--spacing--regular)\"><mark style=\"background-color:#F3F8FB\" class=\"has-inline-color has-blue-color\"><strong>Perspectiva del equipo<\/strong><\/mark><br\/>Para diagn\u00f3sticos habilitados por IA, un sandbox + asesoramiento temprano del panel crea un <strong>plan de doble v\u00eda<\/strong> (evidencia + regulaci\u00f3n) que mantiene el desarrollo seg\u00fan lo previsto y, a la vez, se alinea con las obligaciones de ciberseguridad y datos.<\/p>\n<\/blockquote>\n\n<h2 class=\"wp-block-heading\">Digitalizaci\u00f3n: EUDAMED, UDI y etiquetado electr\u00f3nico<\/h2>\n\n<p>La revisi\u00f3n impulsa lo <strong>digital por defecto<\/strong>:<\/p>\n\n<ul class=\"wp-block-list\">\n<li><strong>DoC digital<\/strong>, presentaciones electr\u00f3nicas, <strong>DT digital<\/strong> entre ON y fabricante, y <strong>eIFU<\/strong> para pruebas cerca del paciente.<\/li>\n\n\n\n<li><strong>Ventas online<\/strong>: la identificaci\u00f3n esencial y las IFU deben estar disponibles para los usuarios.<\/li>\n\n\n\n<li><strong>UDI<\/strong>: se refuerza el <strong>Basic UDI-DI<\/strong> (asignar <strong>antes<\/strong> de la presentaci\u00f3n al ON cuando proceda), m\u00e1s datos UDI p\u00fablicos, proporcionalidad para vol\u00famenes peque\u00f1os\/productos individualizados y condiciones preferentes para pymes.<\/li>\n<\/ul>\n\n<p>Por separado, la Comisi\u00f3n ha se\u00f1alado el <strong>calendario de EUDAMED<\/strong> y su uso obligatorio en <strong>2026<\/strong>, lo que aumenta el valor de poner en orden desde ahora sus datos de UDI y EUDAMED.<\/p>\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p>La revisi\u00f3n espec\u00edfica del MDR\/IVDR es una <strong>correcci\u00f3n de rumbo<\/strong>: requisitos proporcionados, revisiones previsibles y una base digital, sin comprometer la seguridad. Los fabricantes que <strong>act\u00faen pronto<\/strong> \u2014formalizando un di\u00e1logo estructurado con el ON, recalibrando los PSUR e industrializando UDI\/EUDAMED\u2014 convertir\u00e1n la complejidad en <strong>velocidad y resiliencia<\/strong>. Empiece con el plan de 90 d\u00edas; lo dem\u00e1s ser\u00e1 m\u00e1s f\u00e1cil.  <\/p>\n\n<div id=\"download\" class=\"wp-block-group has-white-frost-color has-blue-background-color has-text-color has-background has-link-color wp-elements-e550ab1a03d7fa2672761617d13b1055 has-global-padding is-layout-constrained wp-container-core-group-is-layout-50133c3e wp-block-group-is-layout-constrained\" style=\"min-height:30%;margin-top:var(--wp--preset--spacing--small);margin-bottom:var(--wp--preset--spacing--small);padding-top:var(--wp--preset--spacing--large);padding-right:16%;padding-bottom:var(--wp--preset--spacing--large);padding-left:16%\">\n<h2 class=\"wp-block-heading has-text-align-center\">Descargue el an\u00e1lisis normativo completo<\/h2>\n\n\n\n<p class=\"has-text-align-center\">\u00bfQuiere el <strong>desglose art\u00edculo por art\u00edculo<\/strong>, plantillas (di\u00e1logo estructurado con el ON, cadencia de PSUR, calendario de Basic UDI-DI) y <strong>listas de 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style=\"padding-top:var(--wp--preset--spacing--medium);padding-right:0;padding-bottom:var(--wp--preset--spacing--medium);padding-left:0\">\n<h2 class=\"wp-block-heading\">Preguntas frecuentes<\/h2>\n\n\n\n<div class=\"schema-faq wp-block-yoast-faq-block\"><div class=\"schema-faq-section\" id=\"faq-question-1769085089484\"><strong class=\"schema-faq-question\">\u00bfEsto reduce los est\u00e1ndares de seguridad?<\/strong> <p class=\"schema-faq-answer\">No. La propuesta <strong>mantiene intacta la seguridad<\/strong> mientras simplifica los pasos del proceso y alinea la evidencia con el riesgo.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1769085112925\"><strong class=\"schema-faq-question\">\u00bfCu\u00e1l es el nuevo ritmo del PSUR?<\/strong> <p class=\"schema-faq-answer\">Para <strong>IIb\/III<\/strong>: actualizar <strong>en el a\u00f1o 1<\/strong> y luego <strong>cada 2 a\u00f1os<\/strong>; <strong>IIa<\/strong>: actualizar <strong>cuando sea necesario<\/strong> seg\u00fan el PMS. Los ON revisan los PSUR de determinadas clases de alto riesgo durante la vigilancia. <\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1769085123946\"><strong class=\"schema-faq-question\">\u00bfQu\u00e9 es el \u201cdi\u00e1logo estructurado\u201d en la pr\u00e1ctica?<\/strong> <p class=\"schema-faq-answer\">Un marco formal para interactuar con los ON <strong>antes\/despu\u00e9s de la presentaci\u00f3n<\/strong>, con <strong>planes de control de cambios<\/strong> y una diferenciaci\u00f3n clara de los cambios que requieren notificaci\u00f3n\/aprobaci\u00f3n\/ninguna.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1769085134854\"><strong class=\"schema-faq-question\">\u00bfQu\u00e9 cambia para los IVD de fabricaci\u00f3n interna?<\/strong> <p class=\"schema-faq-answer\">M\u00e1s flexibilidad, incluidas opciones de <strong>transferencia<\/strong> e inclusi\u00f3n de <strong>laboratorios centrales<\/strong> para ensayos cl\u00ednicos dentro de la exenci\u00f3n; eliminaci\u00f3n de la cl\u00e1usula de \u201cproducto no equivalente\u201d.<\/p> <\/div> <div class=\"schema-faq-section\" id=\"faq-question-1769085144388\"><strong class=\"schema-faq-question\">\u00bfD\u00f3nde encajan EUDAMED\/UDI?<\/strong> <p class=\"schema-faq-answer\">Presentaciones digitales, <strong>Basic UDI-DI<\/strong> antes de la presentaci\u00f3n al ON (cuando proceda) y un acceso p\u00fablico m\u00e1s amplio a los datos UDI; planifique ya los hitos de EUDAMED de <strong>2026<\/strong>.<\/p> <\/div> <\/div>\n\n\n\n<div style=\"height:40px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div>\n\n<div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\">\n<h3 class=\"wp-block-heading has-text-align-center\"><strong>\u00bfListo para transformar la complejidad regulatoria en ventaja competitiva?<\/strong><\/h3>\n\n\n\n<p class=\"has-text-align-center\">P\u00f3ngase en contacto con MDx hoy mismo y perm\u00edtanos acompa\u00f1arle en el pr\u00f3ximo cap\u00edtulo del MDR y el IVDR.<\/p>\n<\/div>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-a89b3969 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><button type=\"button\" class=\"wp-block-button__link wp-element-button\">Contact us to request support<\/button><\/div>\n<\/div>\n\n<div style=\"height:50px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Si desarrolla, lanza o mantiene productos sanitarios o IVD en la UE, la revisi\u00f3n espec\u00edfica del MDR\/IVDR es el cambio normativo m\u00e1s importante desde 2017. El 16 de diciembre de 2025, la Comisi\u00f3n Europea public\u00f3 una propuesta para simplificar y agilizar el MDR y el IVDR, reduciendo la carga administrativa y manteniendo sin cambios los requisitos de seguridad. <\/p>\n<p>Con m\u00e1s de 40 consultores que apoyan a fabricantes en el Reino Unido, EE. UU., Espa\u00f1a, B\u00e9lgica, Portugal y el conjunto de la UE, ya hemos traducido la propuesta a un impacto pr\u00e1ctico por funci\u00f3n, clase de producto y cartera. En este art\u00edculo, nuestros expertos desglosan qu\u00e9 est\u00e1 cambiando, qu\u00e9 significa para su organizaci\u00f3n y las acciones concretas que puede empezar este trimestre. <\/p>\n","protected":false},"author":6,"featured_media":9012,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[216],"tags":[218,498,502],"resources-sector":[178,180],"class_list":["post-9814","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog","tag-ivdr-es","tag-mdr","tag-revision-especifica","resources-sector-ivds","resources-sector-medical-devices"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Revisi\u00f3n espec\u00edfica del MDR y el IVDR: \u00bfqu\u00e9 cambia en 2026?<\/title>\n<meta name=\"description\" content=\"Resumen de la revisi\u00f3n espec\u00edfica del MDR y el IVDR 2026: alcance, plazos, recertificaci\u00f3n basada en el riesgo, EUDAMED\/UDI y cambios poscomercializaci\u00f3n.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/mdxcro.com\/es\/mdr-and-ivdr-targeted-revision-2026\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Revisi\u00f3n espec\u00edfica del MDR y el IVDR: \u00bfqu\u00e9 cambia en 2026?\" \/>\n<meta property=\"og:description\" content=\"Resumen de la revisi\u00f3n espec\u00edfica del MDR y el IVDR 2026: alcance, plazos, recertificaci\u00f3n basada en el riesgo, EUDAMED\/UDI y cambios poscomercializaci\u00f3n.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/mdxcro.com\/es\/mdr-and-ivdr-targeted-revision-2026\/\" \/>\n<meta property=\"og:site_name\" content=\"MDx CRO\" \/>\n<meta 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