{"id":34442,"date":"2025-07-10T12:22:21","date_gmt":"2025-07-10T10:22:21","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34442"},"modified":"2025-07-10T15:02:59","modified_gmt":"2025-07-10T13:02:59","slug":"cuales-son-los-plazos-obligatorios-para-adoptar-el-sistema-udi","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/07\/10\/cuales-son-los-plazos-obligatorios-para-adoptar-el-sistema-udi\/","title":{"rendered":"\u00bfCu\u00e1les son los plazos obligatorios para adoptar el sistema UDI?"},"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\"><p>El calendario de implementaci\u00f3n de UDI var\u00eda en funci\u00f3n de la clase de riesgo del dispositivo, seg\u00fan lo establecido en los Reglamentos MDR (UE) 2017\/745 para dispositivos m\u00e9dicos e IVDR (UE) 2017\/746 para dispositivos m\u00e9dicos de diagn\u00f3stico in vitro.<\/p>\n<p>Las fechas de solicitud son las siguientes:<\/p>\n<p><strong>Para productos sanitarios (MDR (UE) 2017\/745):<\/strong><\/p>\n<ul>\n<li><strong>Colocaci\u00f3n de UDI en las etiquetas de los productos:<\/strong>\n<ul>\n<li>Para <strong>la clase III y los dispositivos implantables<\/strong>: el plazo finaliz\u00f3 el 26 de mayo de 2021.<\/li>\n<li>Para la <strong>Clase IIa y la Clase IIb<\/strong>: la fecha l\u00edmite era el 26 de mayo de 2023.<\/li>\n<li>Para <strong>la Clase I<\/strong>: el plazo finaliza el 26 de mayo de 2025.<\/li>\n<\/ul>\n<\/li>\n<li><strong>Marcado directo de productos sanitarios<\/strong>\n<ul>\n<li>Para <strong>la clase III y los dispositivos implantables<\/strong>: el plazo finaliz\u00f3 el 26 de mayo de 2023.<\/li>\n<li>Para las <strong>clases IIa y IIb<\/strong>: el plazo finaliza el 26 de mayo de 2025.<\/li>\n<li>Para <strong>la Clase I<\/strong>: el plazo finaliza el 26 de mayo de 2027.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p><strong>Para productos sanitarios de diagn\u00f3stico in vitro (IVDR (UE) 2017\/746):<\/strong><\/p>\n<ul>\n<li><strong>Colocaci\u00f3n de UDI en las etiquetas de los productos:<\/strong>\n<ul>\n<li>Para <strong>la clase D IVD<\/strong>: la fecha l\u00edmite era el 26 de mayo de 2021.<\/li>\n<li>Para <strong>la Clase C y la Clase B<\/strong>: la fecha l\u00edmite era el 26 de mayo de 2023.<\/li>\n<li>Para <strong>la clase A<\/strong>: el plazo finaliza el 26 de mayo de 2025.<\/li>\n<\/ul>\n<\/li>\n<li><strong>Marcado directo de productos sanitarios<\/strong>\n<ul>\n<li>Para <strong>la clase D IVD<\/strong>: la fecha l\u00edmite era el 26 de mayo de 2023.<\/li>\n<li>Para <strong>la clase C y la clase B<\/strong>: el plazo finaliza el 26 de mayo de 2025.<\/li>\n<li>Para <strong>la clase A<\/strong>: el plazo finaliza el 26 de mayo de 2027.<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<\/div><div class=\"fusion-image-element \" 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