{"id":15792,"date":"2019-06-12T09:32:06","date_gmt":"2019-06-12T07:32:06","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15792"},"modified":"2023-01-26T11:10:47","modified_gmt":"2023-01-26T10:10:47","slug":"cuales-son-los-requisitos-del-mdr-en-materia-de-vigilancia-posterior-al-mercado-vigilancia-del-mercado-y-supervision","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/cuales-son-los-requisitos-del-mdr-en-materia-de-vigilancia-posterior-al-mercado-vigilancia-del-mercado-y-supervision\/","title":{"rendered":"\u00bfCu\u00e1les son los requisitos del MDR en materia de vigilancia posterior al mercado, vigilancia del mercado y supervisi\u00f3n?"},"content":{"rendered":"\r\n<p>Para controlar la trazabilidad de los dispositivos m\u00e9dicos en toda la cadena de suministro, las Regulaciones europeas no s\u00f3lo establecen requisitos m\u00e1s estrictos para los Fabricantes, sino tambi\u00e9n una mayor implicaci\u00f3n por parte de los dem\u00e1s operadores econ\u00f3micos y de los Organismos Notificados.<\/p>\r\n\r\n\r\n\r\n<p>De conformidad con el MDR, el Fabricante tendr\u00e1 que disponer de:<\/p>\r\n\r\n\r\n\r\n<ul class=\"wp-block-list\">\r\n<li>un sistema de gesti\u00f3n de la calidad (SGC);<\/li>\r\n<li>un sistema de vigilancia posterior al mercado (SPM);<\/li>\r\n<li>un sistema de gesti\u00f3n del riesgo;<\/li>\r\n<li>un sistema de notificaci\u00f3n de incidentes y de medidas correctoras de seguridad (vigilancia) a las Autoridades competentes.<\/li>\r\n<\/ul>\r\n\r\n\r\n\r\n<p>El Fabricante tiene que \u201cplanear, establecer, documentar, aplicar, mantener y actualizar un sistema de vigilancia posterior a la comercializaci\u00f3n, parte integrante del sistema de gesti\u00f3n de la calidad de la organizaci\u00f3n\u201d (Ref. Art. 83 del MDR y art. 78 del IVDR).<\/p>\r\n\r\n\r\n\r\n<p>Las actividades inherentes al PMS deben ser garantizadas dentro de la organizaci\u00f3n del Fabricante por una <strong><a href=\"https:\/\/www.thema-med.com\/es\/la-persona-responsable-la-formacion-del-experto-en-asuntos-regulatorios\/\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Persona Responsable<\/a><\/strong> del cumplimiento de la normativa, con una calificaci\u00f3n m\u00ednima (Ref. Art. 15 del MDR).<\/p>\r\n\r\n\r\n\r\n<p class=\"has-text-color has-background\" style=\"background-color: #0099a8; color: #ffffff; text-align: center;\">Preguntas? Solicite m\u00e1s informaci\u00f3n a nuestros especialistas!<br \/><a href=\"https:\/\/www.thema-med.com\/es\/contactanos-2\/\" target=\"_blank\" rel=\"noreferrer noopener\">CONT\u00c1CTANOS<\/a><\/p>\r\n","protected":false},"excerpt":{"rendered":"<p>Para controlar la trazabilidad de los dispositivos m\u00e9dicos en toda la cadena de suministro, las Regulaciones europeas no s\u00f3lo establecen requisitos  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"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-15792","post","type-post","status-publish","format-standard","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>Cu\u00e1les son los requisitos del MDR en materia de vigilancia posterior al mercado, vigilancia del mercado y supervisi\u00f3n?<\/title>\n<meta name=\"description\" content=\"De conformidad con el MDR, el Fabricante tendr\u00e1 que disponer de: un sistema de gesti\u00f3n de la calidad, de vigilancia posterior al mercado, de gesti\u00f3n del ...\" \/>\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\/2019\/06\/12\/cuales-son-los-requisitos-del-mdr-en-materia-de-vigilancia-posterior-al-mercado-vigilancia-del-mercado-y-supervision\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Cu\u00e1les son los requisitos del MDR en materia de vigilancia posterior al mercado, vigilancia del mercado y supervisi\u00f3n?\" \/>\n<meta property=\"og:description\" content=\"De conformidad con el MDR, el Fabricante tendr\u00e1 que disponer de: un sistema de gesti\u00f3n de la calidad, de vigilancia posterior al mercado, de gesti\u00f3n del ...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.thema-med.com\/es\/2019\/06\/12\/cuales-son-los-requisitos-del-mdr-en-materia-de-vigilancia-posterior-al-mercado-vigilancia-del-mercado-y-supervision\/\" \/>\n<meta property=\"og:site_name\" content=\"Thema - 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