{"id":22446,"date":"2022-07-28T15:10:25","date_gmt":"2022-07-28T13:10:25","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=22446"},"modified":"2022-11-17T17:05:58","modified_gmt":"2022-11-17T16:05:58","slug":"swiss-news","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/library\/swiss-news\/","title":{"rendered":"Swiss News"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-background-color:#e8e8e8;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:15px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h3>As well known, as of 26 May 2021 &#8211; following the full implementation of the MDR (EU) 2017\/745 Medical Devices Regulation in Europe and in the absence of an institutional agreement between Switzerland and Europe &#8211; Switzerland became a Third Country for the EU.<\/h3>\n<p>The regulatory system for medical devices has changed in Switzerland, in particular with the Medical Devices Ordinance ODmed SR 812.213.<\/p>\n<p>As a result, EU manufacturers who want to market their medical devices in Switzerland are confronted with numerous new requirements to be fulfilled in accordance with progressive deadlines. In this process of adapting to the new requirements in Switzerland, it is important to follow specific steps and to make sure that these steps are correctly carried out.<\/p>\n<p>&nbsp;<\/p>\n<\/div><\/div><\/div><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-1 fusion_builder_column_1_2 1_2 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:50%;--awb-margin-top-large:15px;--awb-spacing-right-large:3.84%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:3.84%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-title title fusion-title-1 sep-underline sep-solid fusion-title-text fusion-title-size-two\"><h2 class=\"fusion-title-heading title-heading-left fusion-responsive-typography-calculated\" style=\"margin:0;--fontSize:24;--minFontSize:24;line-height:1.2;\">Stay Updated!\u00a0 Subscribe to our service!<\/h2><\/div><!-- Begin Mailchimp Signup Form -->\n<div id=\"mc_embed_signup\">\n    <form action=\"https:\/\/md-24.us20.list-manage.com\/subscribe\/post?u=672feff85a65d12563810beed&id=3c9da60174&v_id=3305&f_id=008637e7f0\" method=\"post\" id=\"mc-embedded-subscribe-form\" name=\"mc-embedded-subscribe-form\" class=\"validate\" target=\"_self\">\n        <div id=\"mc_embed_signup_scroll\">\n        \n        <div class=\"indicates-required\"><span class=\"asterisk\">*<\/span> indicates required<\/div>\n<div class=\"mc-field-group\">\n\t<label for=\"mce-FNAME\">Name <\/label>\n\t<input type=\"text\" value=\"\" name=\"FNAME\" class=\"\" id=\"mce-FNAME\">\n\t<span id=\"mce-FNAME-HELPERTEXT\" class=\"helper_text\"><\/span>\n<\/div>\n<div class=\"mc-field-group\">\n\t<label for=\"mce-LNAME\">Surname <\/label>\n\t<input type=\"text\" value=\"\" name=\"LNAME\" class=\"\" id=\"mce-LNAME\">\n\t<span id=\"mce-LNAME-HELPERTEXT\" class=\"helper_text\"><\/span>\n<\/div>\n<div class=\"mc-field-group\">\n\t<label for=\"mce-BNAME\">Company <\/label>\n\t<input type=\"text\" value=\"\" name=\"BNAME\" class=\"\" id=\"mce-BNAME\">\n\t<span id=\"mce-BNAME-HELPERTEXT\" class=\"helper_text\"><\/span>\n<\/div>\n<div class=\"mc-field-group\">\n\t<label for=\"mce-EMAIL\"> Email  <span class=\"asterisk\">*<\/span>\n<\/label>\n\t<input type=\"email\" value=\"\" name=\"EMAIL\" class=\"required email\" id=\"mce-EMAIL\" required>\n\t<span id=\"mce-EMAIL-HELPERTEXT\" class=\"helper_text\"><\/span>\n<\/div>\n<div class=\"mc-field-group\">\n\t<label for=\"mce-group[238809]\">Language <\/label>\n\t<select name=\"group[238809]\" class=\"REQ_CSS\" id=\"mce-group[238809]\" *|required|*>\n\t<option value=\"\"><\/option>\n\t<option value=\"16\">Italiano<\/option>\n<option value=\"32\">english<\/option>\n<option value=\"64\">espa\u00f1ol<\/option>\n\n\t<\/select>\n\t<span id=\"mce-group[238809]-HELPERTEXT\" class=\"helper_text\"><\/span>\n<\/div>\n<div id=\"mergeRow-gdpr\" class=\"mergeRow gdpr-mergeRow content__gdprBlock mc-field-group\">\n    <div class=\"content__gdpr\">\n        <label>Marketing Permissions<\/label>\n        <p>Please select all the ways you would like to hear from :<\/p>\n        <fieldset class=\"mc_fieldset gdprRequired mc-field-group\" name=\"interestgroup_field\">\n\t\t<label class=\"checkbox subfield\" for=\"gdpr_56312\"><input type=\"checkbox\" id=\"gdpr_56312\" name=\"gdpr[56312]\" value=\"Y\" class=\"av-checkbox gdpr\"><span>Email<\/span> <\/label><label class=\"checkbox subfield\" for=\"gdpr_56316\"><input type=\"checkbox\" id=\"gdpr_56316\" name=\"gdpr[56316]\" value=\"Y\" class=\"av-checkbox gdpr\"><span>Direct Mail<\/span> <\/label>\n        <\/fieldset>\n        <p>I authorise and consent to the processing of my personal data according to <a href=\"https:\/\/www.thema-med.com\/privacy-policy\/#4newsletter\">provided pursuant to Art. 13 of the European Regulation 679\/2016.\n<br>\nYou can unsubscribe at any time by clicking on the link in the footer of our e-mails. <\/p>\n    <\/div>\n    <div class=\"content__gdprLegal\">\n        <p>We use Mailchimp as our marketing platform. 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class=\"button\"><\/div>\n    <\/div>\n<\/form>\n<\/div>\n\n<!--End mc_embed_signup--><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-2 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-order-medium:0;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-order-small:0;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-column-has-shadow fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no\"><style type=\"text\/css\">.fusion-blog-shortcode-1 .fusion-blog-layout-grid .fusion-post-grid{padding:5px;}.fusion-blog-shortcode-1 .fusion-posts-container{margin-left: -5px !important; margin-right:-5px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-3 isotope\" data-pages=\"0\" data-grid-col-space=\"10\" style=\"margin: -5px -5px 0;min-height:500px;\"><article id=\"blog-1-post-19709\" class=\"fusion-post-grid post-19709 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\">\n\n<div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/swiss-exit-what-requirements-should-eu-manufacturers-of-medical-devices-satisfy-now\/\">Swiss Exit: what requirements should EU Manufacturers of Medical Devices satisfy now?<\/a><\/h2><div class=\"fusion-post-content-container\"><p>As of May 26, 2021, Switzerland has fully-fledged become a [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-19712\" class=\"fusion-post-grid post-19712 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\">\n\n<div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/why-is-switzerland-considered-third-country-by-europe\/\">Why is Switzerland considered a Third Country by Europe?<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Starting from May 26, 2021, in accordance with the full [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-19706\" class=\"fusion-post-grid post-19706 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\">\n\n<div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/for-which-medical-devices-is-it-necessary-appoint-ch-rep\/\">For which Medical Devices is it necessary to appoint a Swiss Authorised Representative?<\/a><\/h2><div class=\"fusion-post-content-container\"><p>The designation of the Swiss Authorised Representative (CH REP) is [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-19704\" class=\"fusion-post-grid post-19704 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\">\n\n<div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/do-swiss-rep-and-importers-have-to-register-eudamed\/\">Do Swiss Authorised Representative and Importers of Medical Devices have to register in EUDAMED?<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Since Switzerland is considered a Third Country by the EU, [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-17249\" class=\"fusion-post-grid post-17249 post type-post status-publish format-standard has-post-thumbnail hentry category-blog-en category-swiss-news-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\">\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"border-color:#dbe2ea;\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2021\/05\/31\/mdr-eu-switzerland-third-country-medical-devices\/\" aria-label=\"MDR: Switzerland becomes a Third Country in the Medical Device Sector\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"1024\" height=\"535\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/svizzera-paese-terzo-dispositivi-medici-1024x535-1.png\" class=\"attachment-full size-full wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/svizzera-paese-terzo-dispositivi-medici-1024x535-1-200x104.png 200w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/svizzera-paese-terzo-dispositivi-medici-1024x535-1-400x209.png 400w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/svizzera-paese-terzo-dispositivi-medici-1024x535-1-600x313.png 600w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/svizzera-paese-terzo-dispositivi-medici-1024x535-1-800x418.png 800w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/05\/svizzera-paese-terzo-dispositivi-medici-1024x535-1.png 1024w\" sizes=\"(min-width: 2200px) 100vw, (min-width: 824px) 360px, (min-width: 732px) 540px, (min-width: 640px) 732px, \" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/05\/31\/mdr-eu-switzerland-third-country-medical-devices\/\">MDR: Switzerland becomes a Third Country in the Medical Device Sector<\/a><\/h2><div class=\"fusion-post-content-container\"><p>UPDATE 31\/05\/2021 Since 26 May 2021, with the full application [...]<\/p><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/p>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":0,"parent":8297,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"100-width.php","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-22446","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- 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