{"id":3092,"date":"2026-02-12T00:00:00","date_gmt":"2026-02-11T23:00:00","guid":{"rendered":"https:\/\/pharegistrum.com\/european-guidance-on-breakthrough-medical-devices-btx\/"},"modified":"2026-02-12T00:00:00","modified_gmt":"2026-02-11T23:00:00","slug":"european-guidance-on-breakthrough-medical-devices-btx","status":"publish","type":"post","link":"https:\/\/pharegistrum.com\/en\/european-guidance-on-breakthrough-medical-devices-btx\/","title":{"rendered":"European guidance on breakthrough medical devices (BtX)"},"content":{"rendered":"

The MDCG has recently published Guidance on Breakthrough Devices (BtX) under the MDR and IVDR, clarifying the framework for innovative devices, a classification that did not previously exist.<\/p>\n

A device is considered breakthrough when expected to address unmet medical needs or have a significantly positive clinical impact on serious or life-threatening diseases.<\/p>\n

The guidance clarifies designation criteria; preclinical, clinical and\/or performance evidence; proportionate post-market surveillance; and manufacturer support.<\/p>\n

BtX status does not grant market exclusivity and may apply to several devices with the same intended purpose.<\/p>\n

PhaRegistrum helps manufacturers interpret and implement these frameworks.<\/p>\n

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

View original post on LinkedIn<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

The MDCG has recently published Guidance on Breakthrough Devices (BtX) under the MDR and IVDR, clarifying the framework for innovative devices, a classification that did not previously exist. A device is considered breakthrough when expected to address unmet medical needs or have a significantly positive clinical impact on serious or life-threatening diseases. The guidance clarifies […]<\/p>\n","protected":false},"author":0,"featured_media":2954,"comment_status":"open","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":[1],"tags":[],"class_list":["post-3092","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sem-categoria"],"_links":{"self":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/posts\/3092","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/comments?post=3092"}],"version-history":[{"count":0,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/posts\/3092\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/media\/2954"}],"wp:attachment":[{"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/media?parent=3092"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/categories?post=3092"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharegistrum.com\/en\/wp-json\/wp\/v2\/tags?post=3092"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}