{"id":3093,"date":"2026-02-12T00:00:00","date_gmt":"2026-02-11T23:00:00","guid":{"rendered":"https:\/\/pharegistrum.com\/orientaciones-europeas-sobre-productos-sanitarios-innovadores-btx\/"},"modified":"2026-10-30T20:28:28","modified_gmt":"2026-10-30T19:28:28","slug":"orientaciones-europeas-sobre-productos-sanitarios-innovadores-btx","status":"publish","type":"post","link":"https:\/\/pharegistrum.com\/es\/orientaciones-europeas-sobre-productos-sanitarios-innovadores-btx\/","title":{"rendered":"Orientaciones europeas sobre productos sanitarios innovadores (BtX)"},"content":{"rendered":"

\ud83d\ude80 Orientaciones europeas sobre productos sanitarios innovadores (BtX)<\/p>\n

El Medical Device Coordination Group (MDCG) ha publicado recientemente la Guidance on Breakthrough Devices (BtX), en el contexto del MDR y del IVDR, aclarando el marco reglamentario aplicable a productos sanitarios innovadores \u2014una clasificaci\u00f3n que no exist\u00eda hasta ahora.<\/p>\n

\ud83d\udd0e Un producto se considera innovador cuando se espera que responda a necesidades m\u00e9dicas no cubiertas o tenga un impacto cl\u00ednico significativamente positivo en enfermedades graves o potencialmente mortales.
Estas orientaciones aclaran, entre otros aspectos:
\u2714\ufe0f criterios de designaci\u00f3n como producto innovador;
\u2714\ufe0f requisitos de evidencia precl\u00ednica, cl\u00ednica y\/o de funcionamiento;
\u2714\ufe0f seguimiento poscomercializaci\u00f3n proporcionado;
\u2714\ufe0f mecanismos de apoyo a fabricantes.<\/p>\n

\ud83d\udccc El estatuto BtX no otorga exclusividad de mercado y puede concederse a varios productos con la misma finalidad.<\/p>\n

\ud83d\udc49 PhaRegistrum ayuda a fabricantes a interpretar y aplicar estos nuevos marcos reglamentarios.<\/p>\n

#MedicalDevices
#MDR
#IVDR
#BtX
#Inova\u00e7\u00e3o
#RegulatoryAffairs
#Compliance
#PhaRegistrum<\/p>\n

Ver publicaci\u00f3n original en LinkedIn<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

El Medical Device Coordination Group (MDCG) ha publicado recientemente la Guidance on Breakthrough Devices (BtX), en el contexto del MDR y del IVDR, aclarando el marco reglamentario aplicable a productos sanitarios innovadores \u2014una\u2026<\/p>\n","protected":false},"author":0,"featured_media":2954,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[47],"tags":[],"class_list":["post-3093","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-linkedin-3"],"_links":{"self":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts\/3093","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/comments?post=3093"}],"version-history":[{"count":1,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts\/3093\/revisions"}],"predecessor-version":[{"id":3277,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/posts\/3093\/revisions\/3277"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/media\/2954"}],"wp:attachment":[{"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/media?parent=3093"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/categories?post=3093"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharegistrum.com\/es\/wp-json\/wp\/v2\/tags?post=3093"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}