{"id":24223,"date":"2022-10-21T08:56:16","date_gmt":"2022-10-21T06:56:16","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=24223"},"modified":"2023-01-24T15:08:56","modified_gmt":"2023-01-24T14:08:56","slug":"europa-best-practice-para-la-presentacion-de-documentacion-tecnica","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/10\/21\/europa-best-practice-para-la-presentacion-de-documentacion-tecnica\/","title":{"rendered":"EUROPA: Best Practice para la presentaci\u00f3n de Documentaci\u00f3n T\u00e9cnica"},"content":{"rendered":"<h2>A pesar de que el MDR entr\u00f3 en vigor en 2017 y es totalmente aplicable el 26 de mayo de 2021, todav\u00eda no est\u00e1 claro para los fabricantes de dispositivos m\u00e9dicos c\u00f3mo presentar una Documentaci\u00f3n T\u00e9cnica del producto que sea adecuada a los requisitos y potencialmente aceptable durante la revisi\u00f3n por parte del Organismo Notificado.<\/h2>\n<p>Para facilitar la comprensi\u00f3n de la estructura y el contenido del expediente, <strong>Team NB<\/strong> (la asociaci\u00f3n europea de organismos notificados que operan en el sector m\u00e9dico) ha considerado oportuno publicar el documento de orientaci\u00f3n <a href=\"https:\/\/www.team-nb.org\/team-nb-position-paper-on-bpg-technical-documentation\/\"><em>Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017\/745<\/em><\/a>.<\/p>\n<p>El objetivo de la directriz es ilustrar los requisitos m\u00ednimos b\u00e1sicos que la Documentaci\u00f3n T\u00e9cnica debe tener durante su presentaci\u00f3n, estableciendo as\u00ed un <strong>nivel est\u00e1ndar<\/strong> de expectativas para los Organismos Notificados.<\/p>\n<p>El documento de orientaci\u00f3n presenta en primer lugar las causas m\u00e1s frecuentes de retraso en la revisi\u00f3n de la Documentaci\u00f3n T\u00e9cnica, es decir, <strong>la presentaci\u00f3n de documentaci\u00f3n incompleta <\/strong>y<strong> la incoherencia de la informaci\u00f3n presentada. <\/strong><\/p>\n<p>A continuaci\u00f3n, bas\u00e1ndose en experiencias de revisiones deficientes u omisivas, los organismos ofrecen algunos <strong>consejos pr\u00e1cticos<\/strong>, entre ellos:<\/p>\n<p>&#8211; Antes de la presentaci\u00f3n, los fabricantes deben aclarar de antemano los <strong>requisitos ling\u00fc\u00edsticos<\/strong> con su organismo notificado, as\u00ed como los <strong>requisitos de etiqueta<\/strong> y los m\u00e9todos de presentaci\u00f3n de la documentaci\u00f3n.<\/p>\n<p>&#8211; Es necesario:<\/p>\n<ul>\n<li>proporcionar <strong>report y datos completos y lo m\u00e1s recientes posible<\/strong>,<\/li>\n<li>proporcionar pruebas objetivas del cumplimiento de los <strong>requisitos generales<\/strong> de seguridad y rendimiento (GSPR) aplicables,<\/li>\n<li>garantizar la <strong>correcci\u00f3n y la coherencia<\/strong> de la informaci\u00f3n solicitada en todas las diferentes secciones de la documentaci\u00f3n tambi\u00e9n con respecto a lo declarado en el formulario de solicitud,<\/li>\n<li>Justificar <strong>los datos que faltan<\/strong>, si es necesario.<\/li>\n<\/ul>\n<p>&#8211; Los organismos pueden <strong>hacer uso de las evaluaciones realizadas en el pasado<\/strong> en virtud de las directivas para determinar el cumplimiento de los requisitos del MDR.<\/p>\n<p>&#8211; El fabricante debe seguir proporcionando la documentaci\u00f3n t\u00e9cnica completa de acuerdo con los anexos II y III del MDR.<\/p>\n<p>Aunque cada Organismo Notificado tiene sus propias y peculiares directrices que es necesario conocer y seguir, para facilitar y agilizar el proceso de revisi\u00f3n y conseguir as\u00ed el objetivo de la certificaci\u00f3n, se recomienda que los Fabricantes <strong>tengan en cuenta<\/strong> el documento del Equipo NB, utiliz\u00e1ndolo como referencia complementaria para su propio procedimiento interno de preparaci\u00f3n del expediente, ya adaptado a los Anexos I, II, III y IV del MDR.<\/p>\n<h3><strong>&gt;&gt; \u00bfC\u00f3mo podemos ayudar en el proceso de preparaci\u00f3n de la documentaci\u00f3n t\u00e9cnica y la certificaci\u00f3n del dispositivo?<\/strong><\/h3>\n<p>A trav\u00e9s de nuestros servicios de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">consulencia estrat\u00e9gico-regulatoria<\/a> y de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\">apoyo para la certificaci\u00f3n CE<\/a>, los expertos de Thema pueden guiarle en el cumplimiento de los requisitos del Reglamento de Dispositivos M\u00e9dicos MDR (UE) 2017\/745.<\/p>\n<p><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\">P\u00f3ngase en contacto con nosotros<\/a> para informarse.<\/p>\n<p>Fuente: <a href=\"https:\/\/www.team-nb.org\/team-nb-position-paper-on-bpg-technical-documentation\/\" target=\"_blank\" rel=\"noopener\">https:\/\/www.team-nb.org\/team-nb-position-paper-on-bpg-technical-documentation\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>A pesar de que el MDR entr\u00f3 en vigor en 2017 y es totalmente aplicable el 26 de mayo de 2021,  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":24161,"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-24223","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 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>EUROPA: Best Practice para la presentaci\u00f3n de Documentaci\u00f3n 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