{"id":3334,"date":"2023-05-25T08:19:17","date_gmt":"2023-05-25T08:19:17","guid":{"rendered":"https:\/\/shirobusiness.com\/?p=3334"},"modified":"2023-05-25T08:19:23","modified_gmt":"2023-05-25T08:19:23","slug":"important-regulatory-update-class-i-medical-devices-and-ch-rep-requirements-deadline","status":"publish","type":"post","link":"https:\/\/shirobusiness.com\/important-regulatory-update-class-i-medical-devices-and-ch-rep-requirements-deadline\/","title":{"rendered":"Important Regulatory Update: Class I Medical Devices and CH-REP Requirements Deadline"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"3334\" class=\"elementor elementor-3334\">\n\t\t\t\t\t\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-14c0a17 elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"14c0a17\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"has_ae_slider elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-b8f3589 ae-bg-gallery-type-default\" data-id=\"b8f3589\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-db241e1 elementor-widget elementor-widget-text-editor\" data-id=\"db241e1\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.12.2 - 23-04-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>One of our aims here at Shiro is to help medical device and MedTech companies comply with EU, Swiss and UK regulations. With this in mind, we wanted to ensure you knew of the upcoming deadline to appoint a <a href=\"https:\/\/shirobusiness.com\/importer\/swiss-authorized-representative\/\">CH-REP<\/a> for Class I and system\/procedure pack updates for medical devices.<\/p><p>We notified you about the SwissMedic guidance in our recent blog post, &#8220;<a href=\"https:\/\/shirobusiness.com\/deadline-to-appoint-a-ch-rep-for-class-1-system-procedure-packs-is-approaching\/\">Deadline to appoint a CH-REP for Class 1 &amp; System\/Procedure packs is approaching<\/a>&#8220;, and pointed out that if medical device and MedTech manufacturers wanted to continue placing their devices on the market in Switzerland, then you needed to ensure you had appointed a CH-REP by 31st July 2022.<\/p><p>This date is important, as it is the date when it becomes mandatory for Class I MDR devices to include CH-REP information on the label. This may sound straightforward, but our experience shows that labelling updates can be more time-consuming and complex than they first appear.<\/p><p>Therefore, if you have devices you want to place on the Swiss market, it is better to start preparing for this change now rather than wait until nearer the time.<\/p><p>Shiro Business Solutions work closely with <a href=\"https:\/\/medenvoyglobal.com\/\">MedEnvoy<\/a> \u2013 the largest provider of Swiss Authorised Representative (CH-REP) and Swiss importer services. We are both here to support you in complying with these regulatory changes as efficiently as possible, so please don&#8217;t hesitate to get in touch if you have any questions or require any other assistance.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>One of our aims here at Shiro is to help medical device and MedTech companies comply with EU, Swiss and UK regulations. With this in mind, we wanted to ensure you knew of the upcoming deadline to appoint a CH-REP for Class I and system\/procedure pack updates for medical devices. We notified you about the &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/shirobusiness.com\/important-regulatory-update-class-i-medical-devices-and-ch-rep-requirements-deadline\/\"> <span class=\"screen-reader-text\">Important Regulatory Update: Class I Medical Devices and CH-REP Requirements Deadline<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":4,"featured_media":2545,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-global-header-display":"","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":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","footnotes":""},"categories":[21],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Important Regulatory Update: CH-REP Requirements | Shiro<\/title>\n<meta name=\"description\" content=\"Stay compliant with CH-REP requirements for Class I medical devices. Important regulatory update! Deadline approaching.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/shirobusiness.com\/important-regulatory-update-class-i-medical-devices-and-ch-rep-requirements-deadline\/\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Important Regulatory Update: CH-REP Requirements | Shiro\" \/>\n<meta property=\"og:description\" content=\"Stay compliant with CH-REP requirements for Class I medical devices. Important regulatory update! 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