{"id":7275,"date":"2018-05-18T17:05:22","date_gmt":"2018-05-18T15:05:22","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=7275"},"modified":"2018-05-18T17:05:22","modified_gmt":"2018-05-18T15:05:22","slug":"cuales-son-los-principales-cambios-en-comparacion-la-directiva-9879ce-anterior","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2018\/05\/18\/cuales-son-los-principales-cambios-en-comparacion-la-directiva-9879ce-anterior\/","title":{"rendered":"\u00bfCu\u00e1les son los principales cambios en comparaci\u00f3n con la Directiva 98\/79\/CE anterior?"},"content":{"rendered":"<p>Con el IVDR 2017\/746 se redefine el criterio para clasificar los IVD que ya no se basa en una lista de dispositivos, sino en siete reglas: ahora hay cuatro clases, desde el riesgo m\u00e1s bajo (A) hasta el riesgo m\u00e1s alto (D) establecidas de acuerdo con el uso previsto y la medici\u00f3n de datos anal\u00edticos.<\/p>\n<p>Otros cambios se refieren principalmente a los procedimientos para definir la conformidad y los criterios para evaluar el rendimiento del dispositivo.<\/p>\n<p>Otros cambios afectan el nivel de vigilancia posterior a la comercializaci\u00f3n y la trazabilidad de la seguridad del producto.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Con el IVDR 2017\/746 se redefine el criterio para clasificar los IVD que ya no se basa en una lista de  [&#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":[1559,891],"tags":[],"class_list":["post-7275","post","type-post","status-publish","format-standard","hentry","category-porque-es-necesario-el-marcado-ce","category-faq-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>\u00bfCu\u00e1les son los principales cambios en comparaci\u00f3n con la Directiva 98\/79\/CE anterior? 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