{"id":3040,"date":"2021-11-23T11:27:23","date_gmt":"2021-11-23T03:27:23","guid":{"rendered":"https:\/\/regask.com\/?p=3040"},"modified":"2024-11-01T06:01:23","modified_gmt":"2024-10-31T22:01:23","slug":"guia-sobre-dispositivos-heredados-de-la-ue","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/eu-legacy-devices-guidance\/","title":{"rendered":"UE: MDCG publica documento de orientaci\u00f3n sobre \u201cLegacy Dev\u2026"},"content":{"rendered":"<p>El <a href=\"https:\/\/www.eumonitor.eu\/9353000\/1\/j9vvik7m1c3gyxp\/vkkx77lllly9\" target=\"_blank\" rel=\"noopener\">Grupo de coordinaci\u00f3n de dispositivos m\u00e9dicos<\/a> (MDCG), que es el panel de expertos de los Estados miembros de la UE y la Comisi\u00f3n Europea, public\u00f3 el 20 de octubre un Documento de orientaci\u00f3n para fabricantes, importadores y distribuidores de \u201cdispositivos heredados\u201d sobre las obligaciones MDR que deben cumplir.<\/p>\n<p>El Reglamento (UE) 2017\/745 sobre productos sanitarios (MDR) establece que determinados productos sanitarios certificados con arreglo a la Directiva anterior (Directiva (UE) 93\/42\/CEE) sobre productos sanitarios podr\u00e1n seguir comercializ\u00e1ndose y vendi\u00e9ndose en el mercado de la UE durante un per\u00edodo transitorio despu\u00e9s de la fecha de aplicaci\u00f3n del MDR el 26 de mayo de 2021 sin que dichos productos est\u00e9n espec\u00edficamente certificados con arreglo al MDR, siempre que se puedan cumplir las normas del MDR sobre vigilancia y control.<\/p>\n<p>La Gu\u00eda proporciona informaci\u00f3n detallada sobre el alcance de los informes peri\u00f3dicos de actualizaci\u00f3n de seguridad que deben crearse y enviarse, junto con el hecho de que no es necesario designar una Persona Responsable del Cumplimiento Normativo (PRRC) para dichos dispositivos heredados.<\/p>\n<p>Comun\u00edquese con RegASK para obtener m\u00e1s informaci\u00f3n sobre los cambios en la regulaci\u00f3n de dispositivos m\u00e9dicos. <a href=\"https:\/\/regask.com\/es\/contacto\/\" target=\"_blank\" rel=\"noopener\">Ponte en contacto con los expertos de RegASK.<\/a><\/p>\n<p>&nbsp;<\/p>\n<a href=\"https:\/\/regask.com\/es\/contacto\/\" class=\"button secondary\" style=\"border-radius:10px;\">\n\t\t<span>Contacte con RegASK para m\u00e1s detalles<\/span>\n\t<\/a>\n\n<a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_sector\/docs\/md_mdcg_2021_25_en.pdf\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Leer m\u00e1s<\/span>\n\t<\/a>\n\n<div class=\"row\"  id=\"row-785767605\">\n\n\t<div id=\"col-2079194607\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n<a href=\"https:\/\/regask.com\/es\/estudios-de-caso\/recursos-casos-de-estudio-dispositivos-medicos\/\" target=\"_blank\" class=\"button secondary is-link\" rel=\"noopener\" >\n\t\t<span>Lea estudios de casos de la industria de dispositivos m\u00e9dicos<\/span>\n\t<\/a>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>","protected":false},"excerpt":{"rendered":"<p>El Grupo de Coordinaci\u00f3n de Productos Sanitarios (MDCG), que es el panel de expertos de los Estados miembros de la UE y la Comisi\u00f3n Europea, public\u00f3 el 20 de octubre un Documento de orientaci\u00f3n para fabricantes, importadores y distribuidores de \u201cproductos heredados\u201d sobre las obligaciones del Reglamento sobre Productos Sanitarios (MDR) que deben cumplir. El Reglamento sobre Productos Sanitarios 2017\/745 (MDR) establece que determinados productos certificados bajo el Reglamento sobre Productos Sanitarios (MDR)\u2026<\/p>","protected":false},"author":39,"featured_media":2754,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[40],"class_list":["post-3040","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-devices-insights","tag-latest-insights"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>EU: Legacy Devices Guidance | RegASK<\/title>\n<meta name=\"description\" content=\"The EU MDCG publishes a guidance document on legacy devices. 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