Le gouvernement britannique pr\u00e9voit de modifier les r\u00e9glementations sur les dispositifs m\u00e9dicaux au Royaume-Uni en adoptant les Sp\u00e9cifications Communes de l’UE pour les dispositifs de diagnostic in vitro (IVD) \u00e0 haut risque, y compris ceux utilis\u00e9s pour les maladies infectieuses et l’analyse sanguine.<\/p>\n
Ce changement fait suite \u00e0 un fort soutien pour une proposition visant \u00e0 abroger le processus d’approbation des dispositifs de test Coronavirus (CTDA) en faveur des normes align\u00e9es sur l’UE.<\/p>\n
Un processus CTDA acc\u00e9l\u00e9r\u00e9 sera introduit dans l’intervalle pour les dispositifs COVID-19 portant le marquage CE conform\u00e9ment aux r\u00e8gles europ\u00e9ennes IVD et r\u00e9pondant aux crit\u00e8res des Sp\u00e9cifications Communes.<\/p>\n
Les normes r\u00e9vis\u00e9es am\u00e9lioreront la coh\u00e9rence entre les pays et \u00e9l\u00e8veront les crit\u00e8res de performance pour les tests li\u00e9s au VIH, \u00e0 l’h\u00e9patite, \u00e0 la syphilis et \u00e0 d’autres conditions.<\/p>\n
Rob Reid, directeur adjoint des dispositifs innovants \u00e0 la MHRA, a d\u00e9clar\u00e9 : \u00ab En s’alignant sur les normes d\u00e9j\u00e0 en place \u00e0 travers l’Europe, nous n’am\u00e9liorons pas seulement la s\u00e9curit\u00e9 des patients, mais nous facilitons \u00e9galement la navigation des fabricants \u00e0 travers les exigences r\u00e9glementaires des diff\u00e9rents march\u00e9s. \u00bb<\/p>\n
La mise \u00e0 jour garantira que les diagnostics \u00e0 haut risque soient soutenus par des preuves cliniques solides, permettant des outils plus s\u00fbrs et plus efficaces pour surveiller et traiter les maladies.<\/p>\n
Les r\u00e9glementations finales sont attendues plus tard cette ann\u00e9e dans le cadre de r\u00e9formes plus larges soutenant l’innovation et la transformation des services du NHS.<\/p>\n
Cette initiative vise \u00e0 r\u00e9duire la bureaucratie tout en promouvant des technologies m\u00e9dicales de haute qualit\u00e9 qui r\u00e9pondent aux priorit\u00e9s de sant\u00e9 publique \u00e0 travers le Royaume-Uni.<\/p>\n","protected":false},"excerpt":{"rendered":"
Le gouvernement britannique pr\u00e9voit de modifier les r\u00e9glementations sur les dispositifs m\u00e9dicaux au Royaume-Uni en adoptant les Sp\u00e9cifications Communes de […]<\/p>\n","protected":false},"author":1,"featured_media":353,"comment_status":"open","ping_status":"open","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":"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":"","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-4)","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-4)","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-4)","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":[414],"tags":[],"class_list":["post-352","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nouvelles"],"_links":{"self":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/352","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/comments?post=352"}],"version-history":[{"count":1,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/352\/revisions"}],"predecessor-version":[{"id":357,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/posts\/352\/revisions\/357"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/media\/353"}],"wp:attachment":[{"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/media?parent=352"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/categories?post=352"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.imagerie-medicale-95.fr\/pharmacie\/wp-json\/wp\/v2\/tags?post=352"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}