{"id":4305,"date":"2023-06-20T14:00:38","date_gmt":"2023-06-20T06:00:38","guid":{"rendered":"https:\/\/regask.com\/?p=4305"},"modified":"2024-10-26T02:57:59","modified_gmt":"2024-10-25T18:57:59","slug":"logiciel-britannique-en-tant-que-dispositif-medical","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/uk-software-as-a-medical-device\/","title":{"rendered":"La MHRA britannique a publi\u00e9 des directives sur les logiciels en tant que d\u00e9veloppement m\u00e9dical\u2026"},"content":{"rendered":"<div>\n<div>\n<div>\n<div><a href=\"https:\/\/www.gov.uk\/government\/organisations\/medicines-and-healthcare-products-regulatory-agency\" target=\"_blank\" rel=\"noopener\">MHRA au Royaume-Uni<\/a> L&#039;ann\u00e9e derni\u00e8re, le gouvernement a annonc\u00e9 le programme de changement des logiciels et de l&#039;IA en tant que dispositifs m\u00e9dicaux afin de garantir que les exigences r\u00e9glementaires en mati\u00e8re de logiciels et d&#039;IA soient claires et que les patients soient prot\u00e9g\u00e9s.<\/div>\n<div><\/div>\n<div>La MHRA estime qu&#039;une d\u00e9claration d&#039;objectif inappropri\u00e9e peut conduire \u00e0 un non-respect de la loi et \u00e0 d&#039;\u00e9ventuels probl\u00e8mes de s\u00e9curit\u00e9. Compte tenu du besoin \u00e9mergent de conformit\u00e9 r\u00e9glementaire dans ce domaine, la MHRA a publi\u00e9 les directives sur les logiciels en tant que dispositifs m\u00e9dicaux.<\/div>\n<div><\/div>\n<div>La MHRA tente de d\u00e9crire certaines pr\u00e9occupations courantes concernant\u2026<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div><strong>Plus de d\u00e9tails sur ce document peuvent \u00eatre trouv\u00e9s sur la plateforme RegASK.\u00a0<\/strong><\/div>\n<\/div>\n<div class=\"slider-wrapper relative\" id=\"slider-1689881952\" >\n    <div class=\"slider slider-nav-circle slider-nav-large slider-nav-dark slider-style-normal\"\n        data-flickity-options='{            \"cellAlign\": \"center\",            \"imagesLoaded\": true,            \"lazyLoad\": 1,            \"freeScroll\": false,            \"wrapAround\": true,            \"autoPlay\": 4500,            \"pauseAutoPlayOnHover\" : true,            \"prevNextButtons\": true,            \"contain\" : true,            \"adaptiveHeight\" : true,            \"dragThreshold\" : 10,            \"percentPosition\": true,            \"pageDots\": false,            \"rightToLeft\": false,            \"draggable\": true,            \"selectedAttraction\": 0.1,            \"parallax\" : 0,            \"friction\": 0.6        }'\n        >\n        \n     <\/div>\n\n     <div class=\"loading-spin dark large centered\"><\/div>\n\n\t<\/div>\n\n\n\t<div id=\"gap-2117542499\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-2117542499 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_1223086175\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n<div class=\"row\"  id=\"row-683781905\">\n\n\t<div id=\"col-1715283667\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n\t<section class=\"section\" id=\"section_1039772899\">\n\t\t<div class=\"section-bg fill\" >\n\t\t\t\t\t\t\t\t\t\n\t\t\t\n\n\t\t<\/div>\n\n\t\t\n\n\t\t<div class=\"section-content relative\">\n\t\t\t\n\n<div class=\"row\"  id=\"row-1294733138\">\n\n\n\t<div id=\"col-1230459425\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<h2>D\u00e9sol\u00e9, ce contenu premium est r\u00e9serv\u00e9 aux clients RegASK uniquement.<\/h2>\n<p>Vous souhaitez acc\u00e9der \u00e0 l&#039;int\u00e9gralit\u00e9 du contenu de l&#039;alerte ou parcourir toutes les actualit\u00e9s ?\u00a0<\/p>\n<div class=\"row\"  id=\"row-147775914\">\n\n\n\t<div id=\"col-1838459695\" class=\"col small-12 large-12\"  >\n\t\t\t\t<div class=\"col-inner\"  >\n\t\t\t\n\t\t\t\n\n<a href=\"https:\/\/app.RegASK.com\/#\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Connexion client<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/fr\/demander-une-demo\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>R\u00e9server une d\u00e9mo<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/fr\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Parcourir les actualit\u00e9s<\/span>\n\t<\/a>\n\n\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n\n<\/div>\n\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1039772899 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(255,255,255);\n}\n<\/style>\n\t<\/section>\n\t\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\n\t\n<\/div>\n\t\t<\/div>\n\n\t\t\n<style>\n#section_1223086175 {\n  padding-top: 30px;\n  padding-bottom: 30px;\n  background-color: rgb(0, 49, 117);\n}\n<\/style>\n\t<\/section>\n\t\n\t<div id=\"gap-1468043948\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1468043948 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>UK&#8217;s MHRA announced the Software and AI as a Medical Devices Change Programme last year to ensure regulatory requirements for software and AI are clear and patients are protected. MHRA thinks that an inappropriate intended purpose statement can lead to non-compliance with the law and possible safety concerns and considering the emerging need of regulatory&#8230;<\/p>","protected":false},"author":39,"featured_media":3003,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[526,39],"tags":[40,56],"class_list":["post-4305","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-kingdom-regulations","category-medical-devices-insights","tag-latest-insights","tag-premium-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>UK: Software as a Medical Device | RegASK<\/title>\n<meta name=\"description\" content=\"The MHRA publishes guidance on software as a medical device. 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