{"id":6074,"date":"2022-10-27T12:16:42","date_gmt":"2022-10-27T10:16:42","guid":{"rendered":"https:\/\/www.entecerma.it\/extension-of-the-future-uk-medical-device-regulations-until-2024\/"},"modified":"2022-10-27T12:19:29","modified_gmt":"2022-10-27T10:19:29","slug":"extension-of-the-future-uk-medical-device-regulations-until-2024","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/extension-of-the-future-uk-medical-device-regulations-until-2024\/","title":{"rendered":"Extension of the future UK Medical Device Regulations until 2024"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>MHRA is introducing a 12-month extension to the implementation of the future UK Medical Device Regulations, with the aim to bring the new regulations into force by July 2024.<\/em><\/strong><\/h2>\n\n<p>The future medical device regulations represent a <strong>substantial reform<\/strong> of the current UK medical device regulatory framework. The government is therefore committed to ensuring that the future regulation is robust and implemented through a process that promotes system readiness andminimizes the risk of supply disruptions for UK patients.<\/p>\n\n<p>For this reason, MHRA is putting in place a <strong>twelve-month extension<\/strong> to the current standstill period, in order to provide additional time to develop the legislation and support system readiness.<\/p>\n\n<p>MHRA is now working on the development of future regulations and taking the next steps to implement the <strong>transitional provisions<\/strong> and post-market surveillance requirements, which the government intends to bring into force <strong>by Spring 2023<\/strong>.<\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\"><strong>THE TRANSITIONAL PROVISIONS<\/strong><\/h2>\n\n<p>Today, the current Medical Device Regulations 2002 (<strong>UK MDR 2002<\/strong>) states that devices CE marked will continue to be accepted in Great Britain until 30 June 2023. Differently, the future transitional arrangements set out in the government response outline <strong>an extension to the recognition of CE marked medical devices <\/strong>placed on the Great Britain market.<\/p>\n\n<p>So manufacturers will be able to continue to place CE marked devices on the Great Britain market <strong>after 1st July 2023<\/strong>. From July 2024, the transitional arrangements will apply for CE and UKCA marked devices placed on the Great Britain market.<\/p>\n\n<p>For more information, see the <a href=\"https:\/\/www.gov.uk\/government\/publications\/implementation-of-the-future-regulation-of-medical-devices-and-extension-of-standstill-period\/implementation-of-the-future-regulations\" target=\"_blank\" rel=\"noopener\">MHRA website<\/a><\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading\"><strong>THE SERVICES OF ENTE CERTIFICAZIONE MACCHINE<\/strong><\/h2>\n\n<p>Through the new company <strong>ENTE CERTIFICAZIONE MACCHINE UK LTD<\/strong>, ECM widens the range of services that offers to companies wishing to export their products to the UK market.<\/p>\n\n<p>ECM is currently preparing to get the necessary accreditations to carry out the conformity assessment procedures required for the issue of the <strong>UKCA mark<\/strong>.<\/p>\n\n<p>We are available to provide <strong>information<\/strong> and present our services for the UK market. It is possible to contact our Sales Manager Eng. Diego Stevanella at <a href=\"mailto:diego.s@entecerma.it\">diego.s@entecerma.it<\/a> | mob. (+39) 393 2471040<\/p>\n","protected":false},"excerpt":{"rendered":"<p>MHRA is introducing a 12-month extension to the implementation of the future UK Medical Device&#8230;<\/p>\n","protected":false},"author":2,"featured_media":6072,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[282,905,542,481,906,470,473],"class_list":["post-6074","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-dispositivi-medici-en","tag-great-britain-en","tag-medical-device-en","tag-mhra-en","tag-uk-medical-device-regulations-en","tag-ukca-en","tag-ukca-marking-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Extension of the future UK Medical Device Regulations until 2024 - Ente Certificazione Macchine<\/title>\n<meta name=\"description\" content=\"MHRA is introducing a 12-month extension to the implementation of the future UK Medical Device Regulations, with the aim to bring the new regulations into force by July 2024.\" \/>\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.entecerma.it\/en\/extension-of-the-future-uk-medical-device-regulations-until-2024\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Extension of the future UK Medical Device Regulations until 2024 - 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