{"id":2150,"date":"2021-10-03T18:53:01","date_gmt":"2021-10-03T16:53:01","guid":{"rendered":"https:\/\/www.medsyscon.com\/?p=2150"},"modified":"2021-10-03T19:00:13","modified_gmt":"2021-10-03T17:00:13","slug":"blog-uk-seeks","status":"publish","type":"post","link":"https:\/\/www.medsyscon.com\/en\/blog-uk-seeks\/","title":{"rendered":"UK seeks overhaul of AI, software as a medical device regs"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Greg Slabodkin (Senior Editor) wrote in the current issue of \u201cMEDTECHDIVE\u201d: \u201cThe U.K.&#8217;s Medicines and Healthcare products Regulatory Agency is overhauling its regulations applying to software and artificial intelligence as a medical device.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide a regulatory framework that will ensure &#8220;the U.K. is the home of responsible innovation.&#8221; The U.K. device regulator is seeking changes across the software as a medical device lifecycle, from qualification to classification to pre- and post-market requirements.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The overhaul comes as the FDA issued its own action plan in January for establishing a regulatory approach to such software. Bradley Merrill Thompson, attorney at the law firm Epstein Becker Green, contends that MHRA is a &#8220;small step&#8221; ahead of its U.S. counterpart. Both agencies are looking to achieve their objectives through guidance rather than legislation, Thompson said.&nbsp;&nbsp;&nbsp;&nbsp;<\/p>\n\n\n\n<h1 class=\"wp-block-heading\">Dive Insight:<\/h1>\n\n\n\n<p class=\"wp-block-paragraph\">With the withdrawal of the U.K. from the European Union, MHRA as part of its new Brexit freedoms is moving to update the country&#8217;s regulations for software and AI as a medical device without the burden of accommodating the regulatory approaches of EU members.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;These measures demonstrate the U.K.&#8217;s commitment, following our exit from the European Union, to drive innovation in healthcare and improve patient outcomes,&#8221; states MHRA&#8217;s announcement. &#8220;Regulatory measures will be updated to further protect patient safety and take account of these technological advances.&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">AI and SaMD technologies have the potential for better diagnosing and treating a wide variety of diseases, but FDA has yet to finalize a regulatory framework for machine learning-based software as a medical device. The agency is considering a total product lifecycle-based regulatory framework for adaptive or continuously learning algorithms.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Thompson points out that MHRA is &#8220;basically a small step earlier&#8221; than the FDA&#8217;s AI\/ML-based SaMD action plan issued in January, which calls for further developing a proposed regulatory framework by issuing draft guidance.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">&#8220;It&#8217;s a step earlier because it&#8217;s broader \u2014 it covers a wide variety of regulatory issues for all software as a medical device, not just AI,&#8221; according to Thompson. &#8220;But overall, both governments are trying to do the same thing: outline a path forward for modernizing medical device regulation to address the unique aspects of AI.&#8221;<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">MHRA has working groups developing policy on the different elements articulated in its Software and AI as a Medical Device Change Programme.\u201c<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Please find the complete article&nbsp; <a href=\"https:\/\/www.medtechdive.com\/news\/uk-overhaul-ai-samd-regulations-software-medical-device\/606821\/\"><strong>here<\/strong><\/a>.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For further information please get in touch with us:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"http:\/\/www.medsyscon.com\/en\">www.medsyscon.com\/en<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"mailto:info@medsyscon.com\">info@medsyscon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">+49-176-57694801<\/p>\n\n\n\n<figure class=\"wp-block-image size-large\"><img loading=\"lazy\" decoding=\"async\" width=\"1024\" height=\"254\" src=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2020\/02\/Logo_MedSysCon_Medizintechnik_4C-1024x254.jpg\" alt=\"\" class=\"wp-image-1768\" srcset=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2020\/02\/Logo_MedSysCon_Medizintechnik_4C-1024x254.jpg 1024w, https:\/\/www.medsyscon.com\/wp-content\/uploads\/2020\/02\/Logo_MedSysCon_Medizintechnik_4C-300x74.jpg 300w, https:\/\/www.medsyscon.com\/wp-content\/uploads\/2020\/02\/Logo_MedSysCon_Medizintechnik_4C-768x190.jpg 768w, https:\/\/www.medsyscon.com\/wp-content\/uploads\/2020\/02\/Logo_MedSysCon_Medizintechnik_4C.jpg 1356w\" sizes=\"auto, (max-width: 1024px) 100vw, 1024px\" \/><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>The U.K.&#8217;s Medicines and Healthcare products Regulatory Agency is overhauling its regulations applying to software and artificial intelligence as a medical device.<br \/>\nMHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide &#8230;<\/p>\n","protected":false},"author":5,"featured_media":2151,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[78],"tags":[],"class_list":["post-2150","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-regulatory-consulting"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>UK seeks overhaul of AI, software as a medical device regs - MedSysCon Medizintechnik GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.medsyscon.com\/en\/blog-uk-seeks\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UK seeks overhaul of AI, software as a medical device regs - MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"og:description\" content=\"The U.K.&#039;s Medicines and Healthcare products Regulatory Agency is overhauling its regulations applying to software and artificial intelligence as a medical device. MHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide ...\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.medsyscon.com\/en\/blog-uk-seeks\/\" \/>\n<meta property=\"og:site_name\" content=\"MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"article:published_time\" content=\"2021-10-03T16:53:01+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-10-03T17:00:13+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2021\/10\/pictext.png\" \/>\n\t<meta property=\"og:image:width\" content=\"700\" \/>\n\t<meta property=\"og:image:height\" content=\"435\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@MedSysCon\" \/>\n<meta name=\"twitter:site\" content=\"@MedSysCon\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-uk-seeks\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-uk-seeks\\\/\"},\"author\":{\"name\":\"admin\",\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/#\\\/schema\\\/person\\\/d77306be517a6c2e602e58c10e0246de\"},\"headline\":\"UK seeks overhaul of AI, software as a medical device regs\",\"datePublished\":\"2021-10-03T16:53:01+00:00\",\"dateModified\":\"2021-10-03T17:00:13+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-uk-seeks\\\/\"},\"wordCount\":450,\"publisher\":{\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-uk-seeks\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/www.medsyscon.com\\\/wp-content\\\/uploads\\\/2021\\\/10\\\/pictext.png\",\"articleSection\":[\"Regulatory Consulting\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-uk-seeks\\\/\",\"url\":\"https:\\\/\\\/www.medsyscon.com\\\/en\\\/blog-uk-seeks\\\/\",\"name\":\"UK seeks overhaul of AI, software as a medical device regs - 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