{"id":8550,"date":"2018-12-12T11:59:37","date_gmt":"2018-12-12T10:59:37","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=8550"},"modified":"2023-01-26T12:25:22","modified_gmt":"2023-01-26T11:25:22","slug":"union-europea-actualizado-el-manual-sobre-dispositivos-fronterizos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/12\/12\/union-europea-actualizado-el-manual-sobre-dispositivos-fronterizos\/","title":{"rendered":"UNI\u00d3N EUROPEA: actualizado el manual sobre dispositivos fronterizos"},"content":{"rendered":"<p><img decoding=\"async\" class=\"alignnone wp-image-8544 size-full\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/12\/bordeline-UE-e1544602680491.jpg\" alt=\"\" width=\"721\" height=\"407\" \/><\/p>\n<p>Publicado el 30 de octubre de 2018 por la Comisi\u00f3n Europea, la \u00faltima versi\u00f3n del \u00ab<a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/32208\"><em>Manual on borderline and classification in the community regulatory framework for medical devices <\/em><\/a>\u201d muestra, a trav\u00e9s de seis nuevos ejemplos\/casos, c\u00f3mo interpretar la definici\u00f3n de dispositivo m\u00e9dico y c\u00f3mo aplicar las reglas de clasificaci\u00f3n para dispositivos fronterizos (<em>borderline devices<\/em>).<\/p>\n<p>Los casos a los que se aplica el manual son los siguientes:<\/p>\n<ul>\n<li>no est\u00e1 claro desde el principio si un producto es un dispositivo m\u00e9dico (MD), un dispositivo m\u00e9dico de diagn\u00f3stico in vitro (IVD), un dispositivo m\u00e9dico implantable activo (AIMD) o no;<\/li>\n<li>el producto se ajusta a la definici\u00f3n de dispositivo m\u00e9dico, pero est\u00e1 excluido de las Directivas para su alcance;<\/li>\n<li>hay dificultad en la aplicaci\u00f3n uniforme de las reglas de clasificaci\u00f3n establecidas en el MDD;<\/li>\n<li>existen afirmaciones de naturaleza m\u00e9dica que no pueden ser probadas por datos t\u00e9cnicos, cl\u00ednicos o cient\u00edficos.<\/li>\n<\/ul>\n<p>Por lo tanto, el manual proporciona apoyo para determinar el tipo de dispositivos y su clase de riesgo.<\/p>\n<p>Si bien algunos ejemplos incluidos en el <em>Manual sobre la clasificaci\u00f3n actual y los dispositivos fronterizos\u00a0<\/em>seguir\u00e1n siendo v\u00e1lidos en el MDR, un enfoque caso por caso es crucial, especialmente para los IVD cuya clasificaci\u00f3n ha sufrido cambios importantes.<\/p>\n<p>La versi\u00f3n actual (1.20) es la segunda actualizaci\u00f3n del manual en 2018 y sustituye a la versi\u00f3n publicada en abril.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Publicado el 30 de octubre de 2018 por la Comisi\u00f3n Europea, la \u00faltima versi\u00f3n del \u00abManual on borderline and classification in  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":23492,"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-8550","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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