{"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":"uk-software-als-medizinprodukt","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/uk-software-as-a-medical-device\/","title":{"rendered":"Die britische MHRA hat Leitlinien zu Software als medizinisches Ger\u00e4t ver\u00f6ffentlicht \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\">Britische MHRA<\/a> hat im vergangenen Jahr das \u00c4nderungsprogramm \u201eSoftware und KI als Medizinprodukte\u201c angek\u00fcndigt, um sicherzustellen, dass die regulatorischen Anforderungen f\u00fcr Software und KI klar sind und die Patienten gesch\u00fctzt werden.<\/div>\n<div><\/div>\n<div>Die MHRA ist der Ansicht, dass eine unangemessene Zweckbestimmung zu Gesetzesverst\u00f6\u00dfen und m\u00f6glichen Sicherheitsbedenken f\u00fchren kann. Angesichts der zunehmenden Notwendigkeit der Einhaltung gesetzlicher Vorschriften in diesem Bereich hat die MHRA die Leitlinien zu Software als Medizinprodukt ver\u00f6ffentlicht.<\/div>\n<div><\/div>\n<div>Die MHRA versucht, einige allgemeine Bedenken darzulegen in Bezug auf \u2026<\/div>\n<\/div>\n<div><\/div>\n<\/div>\n<div><strong>Weitere Einzelheiten zu diesem Dokument finden Sie auf der RegASK-Plattform.\u00a0<\/strong><\/div>\n<\/div>\n<div class=\"slider-wrapper relative\" id=\"slider-1320115872\" >\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-1282207827\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-1282207827 {\n  padding-top: 40px;\n}\n<\/style>\n\t<\/div>\n\t\n\n\t<section class=\"section\" id=\"section_535375474\">\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-977195919\">\n\n\t<div id=\"col-235340893\" 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_374287725\">\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-1530585461\">\n\n\n\t<div id=\"col-1285605835\" 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>Entschuldigung, dieser Premium-Inhalt ist nur f\u00fcr RegASK-Kunden.<\/h2>\n<p>M\u00f6chten Sie auf den gesamten Inhalt der Warnung zugreifen oder alle Nachrichten durchsuchen?\u00a0<\/p>\n<div class=\"row\"  id=\"row-1908276211\">\n\n\n\t<div id=\"col-1132575902\" 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>Kunden-Login<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/de\/demo-anfordern\/\" class=\"button secondary lowercase\" style=\"border-radius:5px;\">\n\t\t<span>Demo buchen<\/span>\n\t<\/a>\n\n\n<a href=\"https:\/\/regask.com\/de\/more-insights\/\" target=\"_blank\" class=\"button secondary is-outline\" rel=\"noopener\" >\n\t\t<span>Durchsuchen Sie die Nachrichten<\/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_374287725 {\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_535375474 {\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-946214481\" class=\"gap-element clearfix\" style=\"display:block; height:auto;\">\n\t\t\n<style>\n#gap-946214481 {\n  padding-top: 60px;\n}\n<\/style>\n\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Die britische Arzneimittelbeh\u00f6rde MHRA k\u00fcndigte letztes Jahr das Programm \u201eSoftware und KI als Medizinprodukte\u00e4nderung\u201c an, um klare regulatorische Anforderungen f\u00fcr Software und KI zu gew\u00e4hrleisten und Patienten zu sch\u00fctzen. Die MHRA ist der Ansicht, dass eine unzutreffende Zweckbestimmung zu Gesetzesverst\u00f6\u00dfen und potenziellen Sicherheitsrisiken f\u00fchren kann, und ber\u00fccksichtigt daher den wachsenden Bedarf an regulatorischen Anpassungen\u2026<\/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 v28.7 (Yoast SEO v28.7) - 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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