{"id":7418,"date":"2018-10-15T12:00:07","date_gmt":"2018-10-15T10:00:07","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7418"},"modified":"2023-01-24T15:05:21","modified_gmt":"2023-01-24T14:05:21","slug":"ue-actualizado-el-manual-sobre-dispositivos-fronterizos","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/10\/15\/ue-actualizado-el-manual-sobre-dispositivos-fronterizos\/","title":{"rendered":"UE: actualizado el Manual sobre dispositivos fronterizos"},"content":{"rendered":"<p>El 23 de abril de 2018, el <strong>Medical Devices Expert Group<\/strong> de la Comisi\u00f3n Europea public\u00f3 la versi\u00f3n 19 del <em>\u00abManual on borderline and classification in the community regulatory framework for medical devices\u00bb<\/em> para aclarar la designaci\u00f3n espec\u00edfica de ciertos dispositivos fronterizos.<\/p>\n<p>La clasificaci\u00f3n de los dispositivos fronterizos no est\u00e1 del todo clara, ya que podr\u00edan caer en la definici\u00f3n de dispositivos m\u00e9dicos, dispositivos IVD, medicamentos o de suplemento nutricional.<\/p>\n<p><img decoding=\"async\" class=\"size-full wp-image-7413 alignright\" src=\"http:\/\/www.thema-med.com\/wp-content\/uploads\/2018\/06\/EU.jpg\" alt=\"\" width=\"275\" height=\"183\" \/><\/p>\n<p>Tambi\u00e9n hay casos en los que el producto forma parte de la definici\u00f3n de dispositivo m\u00e9dico pero est\u00e1 excluido de la regulaci\u00f3n debido a su alcance.<\/p>\n<p>En comparaci\u00f3n con la versi\u00f3n anterior publicada en diciembre pasado, este Documento destaca productos adicionales que <strong>ya no se consideran dispositivos m\u00e9dicos<\/strong>.<\/p>\n<p>Ejemplos particulares incluyen el casco de rugby, la l\u00e1mpara germicida de flujo UV, la sierra de autopsia, el filtro de agua y el extracto de Phaseolus vulgaris utilizado en productos diet\u00e9ticos.<\/p>\n<p>Otros productos como los selladores \u00f3seos que contienen factores de crecimiento animal y las c\u00e1maras de Crioterapia se designan, respectivamente, como dispositivos de Clase III y IIb.<\/p>\n<p>Cabe recordar que el Manual se refiere a las Directivas de Dispositivos M\u00e9dicos e IVD, por lo que ser\u00e1 revisado a finales del periodo de transici\u00f3n de los Reglamentos Europeos 2017\/745 y 2017\/746.<\/p>\n<p>Para m\u00e1s informaci\u00f3n:<\/p>\n<p><a href=\"https:\/\/ec.europa.eu\/docsroom\/documents\/29021\" target=\"_blank\" rel=\"noopener\">https:\/\/ec.europa.eu\/docsroom\/documents\/29021<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>El 23 de abril de 2018, el Medical Devices Expert Group de la Comisi\u00f3n Europea public\u00f3 la versi\u00f3n 19 del \u00abManual  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","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-7418","post","type-post","status-publish","format-standard","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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