{"id":7280,"date":"2018-05-18T17:10:15","date_gmt":"2018-05-18T15:10:15","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7280"},"modified":"2018-05-18T17:10:15","modified_gmt":"2018-05-18T15:10:15","slug":"que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/","title":{"rendered":"Qu\u00e9 implica la entrada en vigencia del IVDR 2017\/746 para los fabricantes de dispositivos m\u00e9dicos de diagn\u00f3stico in vitro?"},"content":{"rendered":"<p>El complejo proceso de desarrollo de los dispositivos IVD podr\u00eda ser dif\u00edcil y tomar mucho tiempo para la mayor\u00eda de los fabricantes de dispositivos.&nbsp; Los fabricantes de IVD est\u00e1n invitados a actuar a tiempo para cumplir con la entrada en vigor del nuevo Reglamento.<\/p>\n<p>Entre las innovaciones m\u00e1s importantes cabe mencionar las siguientes: cambios en la clasificaci\u00f3n de los dispositivos (muchos IVD ahora en la categor\u00eda residual, por lo tanto, bajo autodeclaraci\u00f3n, estar\u00e1n sujetos al control del Organismo Notificado), la obligaci\u00f3n de establecer una Persona Responsable, la ejecuci\u00f3n de pruebas para la evaluaci\u00f3n del desempe\u00f1o.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>El complejo proceso de desarrollo de los dispositivos IVD podr\u00eda ser dif\u00edcil y tomar mucho tiempo para la mayor\u00eda de los  [&#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":[892,1556],"tags":[],"class_list":["post-7280","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-why-is-the-ce-marking-required"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Qu\u00e9 implica la entrada en vigencia del IVDR 2017\/746 para los fabricantes de dispositivos m\u00e9dicos de diagn\u00f3stico in vitro? - Thema - Medical Regulatory Consultancy<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qu\u00e9 implica la entrada en vigencia del IVDR 2017\/746 para los fabricantes de dispositivos m\u00e9dicos de diagn\u00f3stico in vitro? - Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"og:description\" content=\"El complejo proceso de desarrollo de los dispositivos IVD podr\u00eda ser dif\u00edcil y tomar mucho tiempo para la mayor\u00eda de los [...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - Medical Regulatory Consultancy\" \/>\n<meta property=\"article:published_time\" content=\"2018-05-18T15:10:15+00:00\" \/>\n<meta name=\"author\" content=\"redazione\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"redazione\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"1 minuto\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/\"},\"author\":{\"name\":\"redazione\",\"@id\":\"https:\/\/www.thema-med.com\/es\/#\/schema\/person\/8cb6614629bd6664e6f294690d35677e\"},\"headline\":\"Qu\u00e9 implica la entrada en vigencia del IVDR 2017\/746 para los fabricantes de dispositivos m\u00e9dicos de diagn\u00f3stico in vitro?\",\"datePublished\":\"2018-05-18T15:10:15+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/\"},\"wordCount\":129,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\/\/www.thema-med.com\/es\/#organization\"},\"articleSection\":[\"FAQ\",\"Why is the CE marking required?\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/\",\"url\":\"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/que-implica-la-entrada-en-vigencia-del-ivdr-2017746-para-los-fabricantes-de-dispositivos-medicos-de-diagnostico-vitro\/\",\"name\":\"Qu\u00e9 implica la entrada en vigencia del IVDR 2017\/746 para los fabricantes de dispositivos m\u00e9dicos de diagn\u00f3stico in vitro? 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