{"id":34641,"date":"2025-08-27T14:21:27","date_gmt":"2025-08-27T12:21:27","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=34641"},"modified":"2025-08-28T16:15:55","modified_gmt":"2025-08-28T14:15:55","slug":"calificacion-de-software-para-ivd-la-guia-de-team-nb","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2025\/08\/27\/calificacion-de-software-para-ivd-la-guia-de-team-nb\/","title":{"rendered":"Calificaci\u00f3n de Software para IVD: La Gu\u00eda de Team-NB"},"content":{"rendered":"

Traducido con inteligencia artificial.<\/strong><\/p>\n

 <\/p>\n

El Team-NB, la asociaci\u00f3n europea de Organismos Notificados para dispositivos m\u00e9dicos, public\u00f3 la segunda versi\u00f3n de su Documento de Posici\u00f3n el 27 de junio de 2025, titulado \u00abTEAM NB Position Paper on Software qualification under the IVDR.\u00bb <\/span><\/p>\n

Desarrollado por el Grupo de Trabajo de Software para IVD, el documento es un recurso valioso para los fabricantes de IVD, ya que aborda uno de los temas con mayor incertidumbre: la calificaci\u00f3n del software seg\u00fan el IVDR (UE) 2017\/746. <\/span><\/p>\n

La segunda versi\u00f3n del Documento de Posici\u00f3n, que actualiza la versi\u00f3n de 2021, se desarroll\u00f3 para alinearse con la reciente directriz MDCG 2019-11 rev.1 del 17 de junio de 2025. <\/span><\/p>\n

El documento refleja la perspectiva de los Organismos Notificados y proporciona aclaraciones pr\u00e1cticas y concretas para ayudar a los fabricantes a decidir si deben o no someter su software a un Organismo Notificado. <\/span><\/p>\n

 <\/p>\n

Calificaci\u00f3n de Software para IVD<\/h2>\n

 <\/p>\n

El documento aborda el tema central de la calificaci\u00f3n del software. Un software se considera un\u00a0 <\/span>dispositivo m\u00e9dico de diagn\u00f3stico in vitro<\/span><\/b> si est\u00e1 destinado a ser utilizado con un fin m\u00e9dico espec\u00edfico, seg\u00fan se define en el Reglamento (UE) 2017\/746. <\/span><\/p>\n

Esta regla se aplica independientemente de si el software es aut\u00f3nomo, forma parte de un dispositivo o influye en su uso. <\/span><\/p>\n

Esta definici\u00f3n es fundamental para los fabricantes, que pueden as\u00ed determinar si su software entra en el \u00e1mbito del IVDR y cu\u00e1les son las expectativas regulatorias. <\/span><\/p>\n

Proporciona un l\u00edmite claro entre el software que tiene una funci\u00f3n diagn\u00f3stica o cl\u00ednica y el software utilizado con fines puramente administrativos. <\/span><\/p>\n

 <\/p>\n

Las Tres V\u00edas de Calificaci\u00f3n<\/h2>\n

 <\/p>\n

Adem\u00e1s de varias aclaraciones de t\u00e9rminos y definiciones, el Documento de Posici\u00f3n propone un <\/span>\u00e1rbol de decisi\u00f3n<\/span><\/b> que ayuda a establecer si un software entra en el \u00e1mbito del IVDR y c\u00f3mo lo hace, distinguiendo tres escenarios: <\/span><\/p>\n

Parte\/Integraci\u00f3n de un Dispositivo:<\/span><\/b> el software es una parte integral de un dispositivo de hardware o gu\u00eda\/influye en su funcionamiento (por ejemplo, software que controla los motores de un microscopio m\u00e9dico digital). <\/span><\/p>\n

En este caso, el software sigue el destino regulatorio del propio dispositivo. <\/span><\/p>\n

<\/div>\n

Dispositivo Aut\u00f3nomo:<\/span><\/b> si el software tiene su propio prop\u00f3sito IVD y funciona por s\u00ed solo (por ejemplo, una aplicaci\u00f3n que analiza im\u00e1genes histol\u00f3gicas para identificar c\u00e9lulas tumorales), se considera un dispositivo IVD y debe clasificarse y evaluarse de forma independiente. <\/span><\/p>\n

<\/div>\n

Accesorio:<\/span><\/b> un producto que, aunque no es un dispositivo IVD en s\u00ed mismo, est\u00e1 destinado a ser utilizado junto con uno o m\u00e1s IVD para permitir su uso o ayudar espec\u00edficamente a su funcionalidad m\u00e9dica. <\/span><\/p>\n

 <\/p>\n

Software Excluido del IVDR<\/h2>\n

 <\/p>\n

El documento tambi\u00e9n proporciona ejemplos pr\u00e1cticos de software que no entran en el \u00e1mbito del IVDR, siempre que se limiten a funciones administrativas o de formaci\u00f3n: <\/span><\/p>\n

 <\/p>\n

LIMS y sistemas de gesti\u00f3n de laboratorio:<\/span><\/b> utilizados \u00fanicamente para funciones de inventario y administrativas. <\/span><\/p>\n

 <\/p>\n

Software de formaci\u00f3n:<\/span><\/b> programas que generan datos simulados con fines educativos o de verificaci\u00f3n. <\/span><\/p>\n

<\/div>\n

Herramientas de visualizaci\u00f3n:<\/span><\/b> software que presenta datos no cl\u00ednicos, como gr\u00e1ficos o diagramas administrativos. <\/span><\/p>\n

<\/div>\n

Si estas herramientas introducen funcionalidades que <\/span>interpretan datos cl\u00ednicos o influyen en las decisiones de diagn\u00f3stico<\/span><\/b>, sin embargo, pueden entrar en el \u00e1mbito del IVDR. <\/span><\/p>\n

 <\/p>\n

Conclusiones<\/h2>\n

 <\/p>\n

La publicaci\u00f3n de esta segunda versi\u00f3n del Documento de Posici\u00f3n representa una se\u00f1al de claridad para un sector que a\u00fan enfrenta muchos <\/span>desaf\u00edos interpretativos<\/span><\/b>. <\/span><\/p>\n

Adem\u00e1s de la <\/span>calificaci\u00f3n<\/span><\/b>, tambi\u00e9n es esencial considerar la <\/span>clasificaci\u00f3n del software<\/span><\/b>: casi todo el software IVD que no sea de Clase A requiere la participaci\u00f3n de un Organismo Notificado. <\/span><\/p>\n

Adem\u00e1s, las empresas deben actuar teniendo en cuenta los pr\u00f3ximos <\/span>plazos del IVDR<\/span><\/b> introducidos por el Reglamento (UE) 2024\/1860. <\/span><\/p>\n

El Documento de Posici\u00f3n de Team-NB no tiene valor legal, pero proporciona una gu\u00eda concreta de quienes realizan las evaluaciones. <\/span><\/p>\n

Para los fabricantes, representa una herramienta \u00fatil para decidir c\u00f3mo calificar y documentar correctamente su software. <\/span><\/p>\n

Para una comprensi\u00f3n completa, se recomienda leer el <\/span>documento completo<\/span><\/b>. <\/span><\/p>\n

<\/div>\n
<\/div>\n

\ud83d\udc49 Solicita una consulta estrat\u00e9gica y regulatoria dirigida para recibir apoyo paso a paso en los procesos de calificaci\u00f3n, registro y conformidad de tus dispositivos m\u00e9dicos de diagn\u00f3stico in vitro (IVD). <\/span><\/p>\n

 <\/p>\n

FUENTE:<\/span><\/b> https:\/\/www.team-nb.org\/team-nb-position-paper-on-software-classification-under-the-ivdr-v2\/<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Traducido con inteligencia artificial.   El Team-NB, la asociaci\u00f3n europea de Organismos Notificados para dispositivos m\u00e9dicos, public\u00f3 la segunda versi\u00f3n de […]<\/p>\n","protected":false},"author":115,"featured_media":34610,"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-34641","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"\nCalificaci\u00f3n de Software para IVD: La Gu\u00eda de Team-NB - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/2025\/08\/27\/calificacion-de-software-para-ivd-la-guia-de-team-nb\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Calificaci\u00f3n de Software para IVD: La Gu\u00eda de Team-NB - 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