{"id":6626,"date":"2021-05-24T08:00:48","date_gmt":"2021-05-24T06:00:48","guid":{"rendered":"https:\/\/digiterm.hu\/digiterm-cumple-la-normativa-mdr\/"},"modified":"2023-07-25T01:02:58","modified_gmt":"2023-07-24T23:02:58","slug":"digiterm-cumple-la-normativa-mdr","status":"publish","type":"post","link":"https:\/\/digiterm.hu\/es\/digiterm-cumple-la-normativa-mdr\/","title":{"rendered":"Digiterm cumple la normativa MDR."},"content":{"rendered":"&#13;\n<p class=\"has-drop-cap\">Digiterm Ltd., presente en el mercado de los dispositivos m\u00e9dicos desde hace 30 a\u00f1os, se ha comprometido a cumplir todos los requisitos m\u00e1s exigentes de las aplicaciones sanitarias. Como ya sabr\u00e1, a finales de mayo de 2021 la Comisi\u00f3n Europea introducir\u00e1 un nuevo Reglamento de Productos Sanitarios con el n\u00famero (UE) 2017\/745 (MDR).<\/p>&#13;\n&#13;\n<p>En comparaci\u00f3n con las directivas anteriores 93\/42\/CEE (MDD), este reglamento contiene normas m\u00e1s estrictas sobre los siguientes aspectos de los productos sanitarios:<\/p>&#13;\n&#13;\n<ul class=\"wp-block-list\">&#13;\n<li>gesti\u00f3n de riesgos<\/li>&#13;\n<li>evaluaci\u00f3n cl\u00ednica del producto sanitario<\/li>&#13;\n<li>estructura de la especificaci\u00f3n t\u00e9cnica y contenido del producto sanitario<\/li>&#13;\n<li>proceso de evaluaci\u00f3n del cumplimiento<\/li>&#13;\n<li>proporcionar una trazabilidad estricta a trav\u00e9s de la vigilancia postcomercializaci\u00f3n<\/li>&#13;\n<\/ul>&#13;\n&#13;\n<figure class=\"wp-block-image size-large\"><img data-recalc-dims=\"1\" decoding=\"async\" class=\"lazyload wp-image-2573 size-fusion-400 aligncenter\" src=\"https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=400%2C400&#038;ssl=1\" data-orig-src=\"https:\/\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1-400x400.jpg\" alt=\"\" width=\"400\" height=\"400\" srcset=\"data:image\/svg+xml,%3Csvg%20xmlns%3D%27http%3A%2F%2Fwww.w3.org%2F2000%2Fsvg%27%20width%3D%27400%27%20height%3D%27400%27%20viewBox%3D%270%200%20400%20400%27%3E%3Crect%20width%3D%27400%27%20height%3D%27400%27%20fill-opacity%3D%220%22%2F%3E%3C%2Fsvg%3E\" data-srcset=\"https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=66%2C66&amp;ssl=1 66w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=150%2C150&amp;ssl=1 150w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=200%2C200&amp;ssl=1 200w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=300%2C300&amp;ssl=1 300w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=400%2C400&amp;ssl=1 400w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=600%2C600&amp;ssl=1 600w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=768%2C768&amp;ssl=1 768w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=800%2C800&amp;ssl=1 800w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=1024%2C1024&amp;ssl=1 1024w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?resize=1200%2C1200&amp;ssl=1 1200w, https:\/\/i0.wp.com\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg?fit=1440%2C1440&amp;ssl=1 1440w\" data-sizes=\"auto\" data-orig-sizes=\"(max-width: 400px) 100vw, 400px\" \/><\/figure>&#13;\n&#13;\n<p>Aunque a\u00f1ade cierta administraci\u00f3n adicional de los productos sanitarios que se encuentran en el mercado, el nuevo sistema ofrece una garant\u00eda adicional al usuario final de que el producto registrado utilizado es seguro, cumple la normativa m\u00e1s estricta y, en caso de que se produzcan imprevistos, ser\u00e1 m\u00e1s f\u00e1cil tomar medidas correctivas y preventivas para evitar que se repitan sucesos similares. Digiterm las cumple incluso hoy, pero a partir de finales de mayo tambi\u00e9n con esta normativa.<\/p>&#13;\n&#13;\n<p>Desde el punto de vista del riesgo, nuestras sillas terap\u00e9uticas pertenecen a la Clase I. Nuestras sillas con medici\u00f3n de peso integrada Comfort-3 Scale y Comfort-4 Scale son excepciones, ya que pertenecen al grupo de riesgo de clase I m. Para estos productos, la nueva normativa no se aplicar\u00e1 hasta despu\u00e9s de 2025, ya que se trata de dispositivos heredados y su cumplimiento es controlado peri\u00f3dicamente por organizaciones externas.<\/p>&#13;\n&#13;\n<p>La normativa estaba prevista para mayo de 2020, pero debido a la pandemia de Covid-19 se ha pospuesto un a\u00f1o. A partir del<sup>25<\/sup> de mayo de 2021, todo nuevo producto sanitario fabricado y aplicado deber\u00e1 cumplir el MDR.<\/p>&#13;\n&#13;\n<p>Tenemos el placer de informarle de que Digiterm ha finalizado la fase de preparaci\u00f3n y ya cumple los requisitos del MDR.<\/p>&#13;\n&#13;\n<p><strong>Actor ID\/SRN : HU-MF-000004201<\/strong><\/p>&#13;\n&#13;\n<p>Ahora que el m\u00f3dulo de registro de EUDAMED est\u00e1 disponible, hemos solicitado y recibido los identificadores UDI-DI para nuestros tipos de productos.<\/p>&#13;\n&#13;\n<p>Como efecto del registro, algunos cambios ser\u00e1n visibles tambi\u00e9n en las etiquetas de las sillas. Estos contendr\u00e1n el identificador UDI-DI del tipo de silla y tambi\u00e9n la denominaci\u00f3n de la silla en el idioma local del destino.<\/p>&#13;\n&#13;\n<p>Al ofrecer soluciones de asientos seguras y de alta calidad en todo el mundo, la satisfacci\u00f3n de nuestros socios siempre ha sido y ser\u00e1 un valor clave para nosotros.<\/p>&#13;\n&#13;\n<p>Si tiene alguna pregunta relacionada con la gesti\u00f3n de la calidad, p\u00f3ngase en contacto con nuestro equipo de SGC y SGMA:<\/p>&#13;\n&#13;\n<p>Correo electr\u00f3nico: <a href=\"mailto:quality@digiterm.hu\">quality@digiterm.hu<\/a><\/p>&#13;\n","protected":false},"excerpt":{"rendered":"<p>Digiterm Ltd., presente en el mercado de dispositivos m\u00e9dicos desde hace 30 a\u00f1os, se ha comprometido a cumplir todos los requisitos m\u00e1s exigentes de las aplicaciones sanitarias. Como ya sabr\u00e1, a finales de mayo de 2021 la Comisi\u00f3n Europea introducir\u00e1 un nuevo Reglamento de Productos Sanitarios con el n\u00famero (UE) 2017\/745 (MDR).<\/p>\n","protected":false},"author":1,"featured_media":5543,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[171,170],"tags":[188,186,184,185,187],"class_list":["post-6626","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-es","category-noticias","tag-ems-es","tag-eudamed-es","tag-mdr-es","tag-normativa-sobre-productos-sanitarios","tag-sgc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Digiterm cumple la normativa MDR. - Digiterm Ltd.<\/title>\n<meta name=\"description\" content=\"Digiterm Ltd., presente en el mercado de los dispositivos m\u00e9dicos desde hace 30 a\u00f1os, se ha comprometido a cumplir todos los requisitos m\u00e1s exigentes de las aplicaciones sanitarias. Como usted sabe, a partir de finales de mayo de 2021 la Comisi\u00f3n Europea introducir\u00e1 un nuevo Reglamento de Productos Sanitarios con el n\u00famero (UE) 2017\/745 (MDR).\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/digiterm.hu\/es\/digiterm-cumple-la-normativa-mdr\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Digiterm cumple la normativa MDR. - Digiterm Ltd.\" \/>\n<meta property=\"og:description\" content=\"Digiterm Ltd., presente en el mercado de los dispositivos m\u00e9dicos desde hace 30 a\u00f1os, se ha comprometido a cumplir todos los requisitos m\u00e1s exigentes de las aplicaciones sanitarias. Como usted sabe, a partir de finales de mayo de 2021 la Comisi\u00f3n Europea introducir\u00e1 un nuevo Reglamento de Productos Sanitarios con el n\u00famero (UE) 2017\/745 (MDR).\" \/>\n<meta property=\"og:url\" content=\"https:\/\/digiterm.hu\/es\/digiterm-cumple-la-normativa-mdr\/\" \/>\n<meta property=\"og:site_name\" content=\"Digiterm Ltd.\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/digiterm.hu\/\" \/>\n<meta property=\"article:published_time\" content=\"2021-05-24T06:00:48+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2023-07-24T23:02:58+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/digiterm.hu\/wp-content\/uploads\/2021\/07\/MDR_NEWSLETTER_GRAPH_1_1.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1440\" \/>\n\t<meta property=\"og:image:height\" content=\"1440\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Bertalan Petrik\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Bertalan Petrik\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/\"},\"author\":{\"name\":\"Bertalan Petrik\",\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/#\\\/schema\\\/person\\\/a0700bbf8790e72d00e0ce51578f0ab5\"},\"headline\":\"Digiterm cumple la normativa MDR.\",\"datePublished\":\"2021-05-24T06:00:48+00:00\",\"dateModified\":\"2023-07-24T23:02:58+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/\"},\"wordCount\":468,\"publisher\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/i0.wp.com\\\/digiterm.hu\\\/wp-content\\\/uploads\\\/2021\\\/07\\\/MDR_NEWSLETTER_GRAPH_1_1.jpg?fit=1440%2C1440&ssl=1\",\"keywords\":[\"EMS\",\"EUDAMED\",\"MDR\",\"Normativa sobre productos sanitarios\",\"SGC\"],\"articleSection\":[\"Blog\",\"Noticias\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/\",\"url\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/\",\"name\":\"Digiterm cumple la normativa MDR. - Digiterm Ltd.\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/digiterm.hu\\\/es\\\/digiterm-cumple-la-normativa-mdr\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/i0.wp.com\\\/digiterm.hu\\\/wp-content\\\/uploads\\\/2021\\\/07\\\/MDR_NEWSLETTER_GRAPH_1_1.jpg?fit=1440%2C1440&ssl=1\",\"datePublished\":\"2021-05-24T06:00:48+00:00\",\"dateModified\":\"2023-07-24T23:02:58+00:00\",\"description\":\"Digiterm Ltd., presente en el mercado de los dispositivos m\u00e9dicos desde hace 30 a\u00f1os, se ha comprometido a cumplir todos los requisitos m\u00e1s exigentes de las aplicaciones sanitarias. 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