{"id":2544,"date":"2022-07-25T10:37:58","date_gmt":"2022-07-25T10:37:58","guid":{"rendered":"https:\/\/shirobusiness.com\/?p=2544"},"modified":"2023-04-17T09:31:29","modified_gmt":"2023-04-17T09:31:29","slug":"deadline-to-appoint-a-ch-rep-for-class-1-system-procedure-packs-is-approaching","status":"publish","type":"post","link":"https:\/\/shirobusiness.com\/deadline-to-appoint-a-ch-rep-for-class-1-system-procedure-packs-is-approaching\/","title":{"rendered":"Deadline to appoint a CH-REP for Class 1 &#038; System\/Procedure packs is approaching"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"2544\" class=\"elementor elementor-2544\">\n\t\t\t\t\t\t\t\t\t<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-1cb061fb elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"1cb061fb\" 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-6d201eea ae-bg-gallery-type-default\" data-id=\"6d201eea\" 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-3a621cc2 elementor-widget elementor-widget-text-editor\" data-id=\"3a621cc2\" 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<!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">The deadline for appointing a <a href=\"https:\/\/shirobusiness.com\/importer\/swiss-authorized-representative\/\">Swiss Authorised Representative (CH-REP)<\/a> for Class 1 Devices, and System\/Procedure Packs is fast approaching.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">The legislation states that if medical device manufacturers want to continue placing their devices on the Swiss market, they must appoint their CH-REP by<strong> 31 July 2022.<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">By this point, your medical device labelling must include the name and address of your CH-REP. With this in mind, <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home.html\">Swissmedic<\/a> has released a <a href=\"https:\/\/www.swissmedic.ch\/swissmedic\/en\/home\/medical-devices\/market-access\/ch-rep.html\">CH-REP symbol<\/a> to be used on the packaging &#8211; similar to how the EC-REP symbol is used.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\"><strong>Why does Swissmedic now require you to have a CH-REP?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">Switzerland is not part of the EU, but they have traditionally had agreements with the EU to allow for a smooth flow of goods across EU borders. These agreements are called <a href=\"https:\/\/single-market-economy.ec.europa.eu\/single-market\/goods\/international-aspects-single-market\/mutual-recognition-agreements_en\">Mutual Recognition Agreements (MRAs<\/a>) and allow manufacturers from Switzerland and European countries to sell across their borders without the need to comply with the rules that may apply to so-called &#8220;third countries.&#8221;<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">\u00a0However, EU and Swiss legislators could not agree on other specific issues, and they reached no actual agreement relating to the import\/export of medical devices before the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32017R0745\">EU MDR<\/a> came into effect in May 2021. This lack of accord led to Switzerland becoming much like the UK regarding medical devices.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">As there was no MRA in place, all medical device manufacturers outside of Switzerland, even those who are EU based, now have to register their company and the devices they produce in Switzerland AND appoint a Swiss Authorised Representative (CH-REP). There are deadlines associated with this, two of which have already passed and one fast approaching.<\/p>\n<!-- \/wp:paragraph --><!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>The deadline for appointing a CH-REP for Class IIb, Class III and active implantable devices was <strong>31 December 2021<\/strong><\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>The deadline for appointing a CH-REP for Class IIa, and Class IIb non-implantable devices was <strong>31 March 2022<\/strong><\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>The deadline for appointing a CH-REP for Class I and System\/Procedure Packs is <strong>31 July 2022<\/strong><\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\"><strong>Do I need to appoint anyone else besides a CH-REP to sell my medical device in Switzerland?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">Ideally, yes, you do. As well as appointing a CH-REP, there is a requirement for a CH-Importer. If you do not appoint an independent Importer for Switzerland, this role, by default, falls upon your customer. This means that they must meet all of the obligations of the MedDO and take legal liability and responsibility for 1<sup>st<\/sup> placement of the product on the Swiss market. Not an ideal situation for your customers.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">The<a href=\"https:\/\/shirobusiness.com\/importer\/switzerland-importer\/\"> Swiss importer<\/a> has a critical role in helping ensure you comply with the Swiss Medical Devices Ordinance (<a href=\"https:\/\/www.fedlex.admin.ch\/eli\/cc\/2020\/552\/en\">MedDO<\/a>) rather than dealing with the logistics side of things.<\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">The legal obligations associated with a Swiss importer include the following:<\/p>\n<!-- \/wp:paragraph --><!-- wp:list -->\n<ul><!-- wp:list-item -->\n<li>Ensuring the device is labelled according to Swiss MedDO requirements, including a listing of the importer<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Maintaining a copy of the Declaration of Conformity and relevant certificates<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Verifying that a tri-lingual IFU exists<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Verifying UDIs have been assigned<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Informing manufacturers, distributors and CH-REP about complaints, field actions etc.<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Maintaining a register to ensure that non-compliant products are not sold in Switzerland.<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Telling Swissmedic if the importer believes the device does not comply with MedDO<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Checking that storage and transportation conditions are suitable for the products.<\/li>\n<!-- \/wp:list-item --><!-- wp:list-item -->\n<li>Cooperating with Swissmedic as required<\/li>\n<!-- \/wp:list-item --><\/ul>\n<!-- \/wp:list --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\"><strong>How can Shiro Business Solutions help you comply with the new regulations?<\/strong><\/p>\n<!-- \/wp:paragraph --><!-- wp:paragraph {\"textColor\":\"ast-global-color-2\"} -->\n<p class=\"has-ast-global-color-2-color has-text-color\">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 ideally placed to help you ensure you are complying with the Swiss MedDO regulations.<\/p>\n<!-- \/wp:paragraph -->\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<section class=\"has_ae_slider elementor-section elementor-top-section elementor-element elementor-element-b4c225f elementor-section-boxed elementor-section-height-default elementor-section-height-default ae-bg-gallery-type-default\" data-id=\"b4c225f\" 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-e97203d ae-bg-gallery-type-default\" data-id=\"e97203d\" 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-1281309 elementor-widget elementor-widget-author-box\" data-id=\"1281309\" data-element_type=\"widget\" data-widget_type=\"author-box.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/shirobusiness.com\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<div class=\"elementor-author-box\">\n\t\t\t\t\t\t\t<div  class=\"elementor-author-box__avatar\">\n\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/shirobusiness.com\/wp-content\/uploads\/2023\/03\/julian.jpeg\" alt=\"Julian Relf\">\n\t\t\t\t<\/div>\n\t\t\t\n\t\t\t<div class=\"elementor-author-box__text\">\n\t\t\t\t\t\t\t\t\t<div >\n\t\t\t\t\t\t<h4 class=\"elementor-author-box__name\">\n\t\t\t\t\t\t\tJulian Relf\t\t\t\t\t\t<\/h4>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-author-box__bio\">\n\t\t\t\t\t\t<p>I have a wealth of experience and success gained in UK and European sales, marketing and management roles within the Medical Devices and Medical fields with both Start-up and Blue-chip companies.<\/p>\n\t\t\t\t\t<\/div>\n\t\t\t\t\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/div>\n\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>The deadline for appointing a Swiss Authorised Representative (CH-REP) for Class 1 Devices, and System\/Procedure Packs is fast approaching.<\/p>\n","protected":false},"author":5,"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":[14],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>July 2022: Swiss deadline Class I devices | Shiro Business Solutions<\/title>\n<meta name=\"description\" content=\"Deadline to appoint a CH-REP for Class I devices &amp; System\/Procedure Packs is approaching. 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