{"id":23852,"date":"2022-09-20T16:22:31","date_gmt":"2022-09-20T14:22:31","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=23852"},"modified":"2022-09-22T10:32:41","modified_gmt":"2022-09-22T08:32:41","slug":"europa-mdcg-2022-14-acciones-inmediatas-previstas-para-facilitar-la-transicion-a-la-mdr-ivdr","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2022\/09\/20\/europa-mdcg-2022-14-acciones-inmediatas-previstas-para-facilitar-la-transicion-a-la-mdr-ivdr\/","title":{"rendered":"EUROPA: MDCG 2022-14 | Acciones inmediatas previstas para facilitar la transici\u00f3n a la MDR\/IVDR"},"content":{"rendered":"<h2>Hasta la fecha, sigue siendo dif\u00edcil para los fabricantes llevar a cabo la certificaci\u00f3n MDR o IVDR de forma <strong>clara, accesible<\/strong> y que garantice la <strong>continuidad<\/strong> de la comercializaci\u00f3n de los dispositivos.<\/h2>\n<p>Por eso, la Directriz 2022-14 del MDCG <a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2022-14-transition-mdr-and-ivdr-notified-body-capacity-and-availability-medical-devices-and-2022-08-26_en\"><em>Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs<\/em><\/a>, publicada el pasado mes de agosto, enumera las medidas inmediatas que deben adoptar los organismos notificados, los fabricantes y los comerciantes en general.<\/p>\n<p>Entre las recomendaciones comunicadas por el Grupo de Coordinaci\u00f3n de Dispositivos M\u00e9dicos a los <strong>Organismos Notificados<\/strong>, algunas son especialmente significativas:<\/p>\n<ul>\n<li>utilizar auditor\u00edas h\u00edbridas;<\/li>\n<li>promover el desarrollo de los Organismos Notificados mediante actividades de formaci\u00f3n, entrenamiento y pr\u00e1cticas para su personal. Adem\u00e1s, los Organismos Notificados deben racionalizar los procedimientos administrativos internos;<\/li>\n<li>acelerar el proceso de evaluaci\u00f3n, designaci\u00f3n y notificaci\u00f3n de los Organismos Notificados;<\/li>\n<li>a\u00f1adir oportunamente los c\u00f3digos de designaci\u00f3n del Organismo Notificado;<\/li>\n<li>permitir flexibilidad a los Operadores Econ\u00f3micos, Organismos Notificados y Autoridades Competentes en c\u00f3mo demonstrar el cumplimiento de los requisitos legales en un plazo razonable.<\/li>\n<\/ul>\n<p>Tambi\u00e9n hay requisitos para los Organismos, como hacer p\u00fablicas las <strong>tarifas<\/strong> y que sean f\u00e1cilmente comparables, y proporcionar recursos para la asistencia a las peque\u00f1as y medianas empresas y a las organizaciones que se introducen en el mercado m\u00e9dico por primera vez, incluido el suministro de informaci\u00f3n a trav\u00e9s de directrices comunes y el intercambio de contenidos.<\/p>\n<p>Adem\u00e1s, la directriz insta a los fabricantes a <strong>no esperar<\/strong> hasta el final del Per\u00edodo de gracia para proceder al inicio de la certificaci\u00f3n y recomienda <strong>reuniones y di\u00e1logos estructurados<\/strong> con el Organismo Notificado antes y durante el proceso de evaluaci\u00f3n de la conformidad.<\/p>\n<p>Con la directriz del MDCG 2022-14, la Comisi\u00f3n Europea dio <strong>un primer paso importante<\/strong> para resolver cuestiones significativas que a\u00fan est\u00e1n presentes y que podr\u00edan retrasar el acceso al mercado de los dispositivos m\u00e9dicos in vitro y de diagn\u00f3stico in vitro.<\/p>\n<p>&gt;&gt; A trav\u00e9s de nuestros servicios de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/consultoria-estrategico-regulatoria\/\">consulencia estrat\u00e9gico-regulatoria<\/a>, <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/apoyo-para-la-certificacion-ce\/\">apoyo para la certificaci\u00f3n CE<\/a> y, si es necesario, de <a href=\"https:\/\/www.thema-med.com\/es\/servicios\/representante-local\/servicio-representante-autorizado-europeo\/\">Representante Europeo Autorizado<\/a>, Thema puede apoyarle en el cumplimiento de los requisitos del Reglamento de Dispositivos M\u00e9dicos MDR (EU) 2017\/745 y de Dispositivos de Diagn\u00f3stico In Vitro IVDR (EU) 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\/2022-08\/mdcg_2022-14_en.pdf\">https:\/\/health.ec.europa.eu\/system\/files\/2022-08\/mdcg_2022-14_en.pdf<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hasta la fecha, sigue siendo dif\u00edcil para los fabricantes llevar a cabo la certificaci\u00f3n MDR o IVDR de forma clara, accesible  [&#8230;]<\/p>\n","protected":false},"author":114,"featured_media":23773,"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-23852","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: MDCG 2022-14 | Acciones inmediatas previstas para facilitar la transici\u00f3n a la MDR\/IVDR<\/title>\n<meta name=\"description\" content=\"La Directriz 2022-14 del MDCG Transition to the MDR and IVDR Notified body capacity and availability of medical devices and IVDs...\" \/>\n<meta name=\"robots\" content=\"index, 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