{"id":23850,"date":"2022-09-20T16:22:08","date_gmt":"2022-09-20T14:22:08","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=23850"},"modified":"2022-09-20T16:26:14","modified_gmt":"2022-09-20T14:26:14","slug":"europa-publicada-una-directriz-para-los-producto-borderline-segun-el-mdr-y-el-ivdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/09\/20\/europa-publicada-una-directriz-para-los-producto-borderline-segun-el-mdr-y-el-ivdr\/","title":{"rendered":"EUROPA: publicada una directriz para los dispositivos borderline seg\u00fan el MDR y el IVDR"},"content":{"rendered":"<h2>La directriz <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/md_borderline_manual_09-2022_en.pdf\"><em>Manual on borderline and classification for medical devices under Regulation (EU) 2017\/745 on medical devices and Regulation (EU) 2017\/746 on in vitro diagnostic medical devices<\/em><\/a>, publicada en la versi\u00f3n 1 ayuda a determinar si un <strong>producto borderline<\/strong> entra en la definici\u00f3n de dispositivo m\u00e9dico y seg\u00fan qu\u00e9 normas de clasificaci\u00f3n.<\/h2>\n<p>El documento, en el que se citan ejemplos y casos pr\u00e1cticos, pretende aclarar las normas de comercializaci\u00f3n de un dispositivo cuando <strong>no se define inmediatamente<\/strong> como dispositivo m\u00e9dico (o DIV) por qu\u00e9 est\u00e0 en la frontera con los DIV, los medicamentos, los cosm\u00e9ticos, los biocidas, los alimentos, los equipos de protecci\u00f3n individual, los productos de consumo u otras categor\u00edas.<\/p>\n<p>Una vez identificado como dispositivo m\u00e9dico o DIV, es necesario identificar la <strong>clase de riesgo<\/strong>plicable, es decir, I, IIa, IIb, III (para dispositivo m\u00e9dico) o A, B, C y D en el caso de dispositivos DIV. Las normas de clasificaci\u00f3n de los dispositivo m\u00e9dico se rigen por el art\u00edculo 51 Clasificaci\u00f3n de los dispositivos y el anexo VIII del MDR (UE) 2017\/745. Para el IVDR (UE) 2017\/746, las referencias correspondientes son el art\u00edculo 47 y el anexo VIII. En la directriz hay <strong>algunos casos<\/strong> de clasificaci\u00f3n en los que las autoridades competentes de los Estados miembros tienen dificultades para aplicar las normas de clasificaci\u00f3n de manera uniforme.<\/p>\n<p>El manual, redactado por los miembros de los Estados miembros del Grupo de Trabajo de Fronteras y Clasificaci\u00f3n, un subgrupo del Grupo de Coordinaci\u00f3n de Dispositivos M\u00e9dicos, es un importante punto de referencia para los fabricantes a la hora de evaluar la conformidad de los dispositivos, aunque debe aplicarse <strong>caso por caso<\/strong> de acuerdo con la normativa de la UE, sujeto a la decisi\u00f3n final de las autoridades competentes de los distintos Estados miembros y de los tribunales nacionales.<\/p>\n<p>&gt;&gt; A trav\u00e9s de la <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">consulencia estrat\u00e9gico-regulatoria<\/a>, los expertos de Thema pueden apoyarle en la clasificaci\u00f3n del dispositivo borderline sobre la base del manual y en cumplimiento de los requisitos del Reglamento de Dispositivos M\u00e9dicos MDR (UE) 2017\/745 y Dispositivos de Diagn\u00f3stico In Vitro IVDR (UE) 2017\/746.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\">P\u00f3ngase en contacto con nosotros<\/a> para m\u00e1s informaci\u00f3n.<\/p>\n<p>Fuente: <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/md_borderline_manual_09-2022_en.pdf\">https:\/\/health.ec.europa.eu\/system\/files\/2022-09\/md_borderline_manual_09-2022_en.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>La directriz Manual on borderline and classification for medical devices under Regulation (EU) 2017\/745 on medical devices and Regulation (EU) 2017\/746  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":23768,"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-23850","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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