{"id":7297,"date":"2021-05-28T08:57:29","date_gmt":"2021-05-28T06:57:29","guid":{"rendered":"https:\/\/www.riskmanager.net\/?p=7297"},"modified":"2021-05-28T09:52:40","modified_gmt":"2021-05-28T07:52:40","slug":"kein-abkommen-zwischen-der-schweiz-und-der-eu-folgen-fuer-die-medtech-branche","status":"publish","type":"post","link":"https:\/\/www.riskmanager.net\/en\/2021\/05\/28\/kein-abkommen-zwischen-der-schweiz-und-der-eu-folgen-fuer-die-medtech-branche\/","title":{"rendered":"Kein Abkommen zwischen der Schweiz und der EU: Folgen f\u00fcr die Medtech-Branche"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbho9e-bb8ea5eed3615d58f7e0433486184a11\">\n.avia-section.av-kkwbho9e-bb8ea5eed3615d58f7e0433486184a11{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/05\/shutterstock_695865433.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-kkwbho9e-bb8ea5eed3615d58f7e0433486184a11 .av-section-color-overlay{\nopacity:0.3;\nbackground-color:#000000;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-kkwbho9e-bb8ea5eed3615d58f7e0433486184a11 main_color avia-section-default avia-no-border-styling  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7297'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-bjkpou-4d21ae85a694f724a081997bbbff889f main_color avia-section-default avia-no-border-styling  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7297'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-9r4r66-90380a229f4631b5c0d2990376471ae0\">\n.flex_column.av-9r4r66-90380a229f4631b5c0d2990376471ae0{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-9r4r66-90380a229f4631b5c0d2990376471ae0 av_four_fifth  avia-builder-el-2  el_before_av_four_fifth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kp7yu25r-625057c5f90edb4ca6933f204aa98567\">\n#top .av-special-heading.av-kp7yu25r-625057c5f90edb4ca6933f204aa98567{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-kp7yu25r-625057c5f90edb4ca6933f204aa98567 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-kp7yu25r-625057c5f90edb4ca6933f204aa98567 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-kp7yu25r-625057c5f90edb4ca6933f204aa98567 av-special-heading-h1 blockquote modern-quote  avia-builder-el-3  avia-builder-el-no-sibling '><div class='av-subheading av-subheading_above'><p>Consequences for the medtech industry<\/p>\n<\/div><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >No agreement between Switzerland and the EU<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-4  el_after_av_four_fifth  avia-builder-el-last  first flex_column_div av-zero-column-padding  '     ><p><section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>It has burst. The new agreement between Switzerland and the EU will not enter into force. After seven years of negotiations between representatives of the EU Commission and Switzerland, President Guy Parmelin declared the talks a failure yesterday. The reason, he said, was disagreement on crucial points of the negotiations, such as access to the EU\u2019s internal market and agreements on the free movement of persons. The modernisation of the agreement, which has been in place since 1972, has thus failed to materialise.<\/p>\n<p>A failure that particularly affects the Swiss medtech sector shortly after the transition to the new MDR 2017\/745. What does this mean for access to the EU internal market?<\/p>\n<\/div><\/section><br \/>\n<section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Due to the loss of privileged access, Switzerland will now be downgraded to the status of a third country. Manufacturers must therefore adapt when placing new medical devices on the European market.<\/p>\n<p>The consequences are additional work due to increased requirements and having to go through the European approval process. In addition to the designation of a specific Notified Body, the preparation of corresponding technical documentation is also required.<\/p>\n<\/div><\/section><\/p><\/div>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-6ypsa6-d2627cd27a8d374f4033582c323d42ae\">\n.avia-section.av-6ypsa6-d2627cd27a8d374f4033582c323d42ae{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2021\/04\/shutterstock_192479969-scaled.jpg);\nbackground-position:0% 50%;\nbackground-attachment:scroll;\n}\n.avia-section.av-6ypsa6-d2627cd27a8d374f4033582c323d42ae .av-section-color-overlay{\nopacity:0.9;\nbackground-color:#3f3f3f;\n}\n<\/style>\n<div id='av_section_3'  class='avia-section av-6ypsa6-d2627cd27a8d374f4033582c323d42ae alternate_color avia-section-default avia-no-border-styling  avia-builder-el-7  el_after_av_section  el_before_av_section  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7297'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_three_fourth  avia-builder-el-8  el_before_av_one_fourth  avia-builder-el-first  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-be67e7722bb2fe8a35bb7d5cba3e07de\">\n#top .av-special-heading.av-av_heading-be67e7722bb2fe8a35bb7d5cba3e07de{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-be67e7722bb2fe8a35bb7d5cba3e07de .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-be67e7722bb2fe8a35bb7d5cba3e07de .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-be67e7722bb2fe8a35bb7d5cba3e07de av-special-heading-h3 blockquote modern-quote  avia-builder-el-9  el_before_av_textblock  avia-builder-el-first '><h3 class='av-special-heading-tag '  itemprop=\"headline\"  >As a Swiss company, are you affected by the collapsed framework agreement? <\/h3><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-kkwbj1na-aaae942871a562d489d49038a1da7612 '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Contact us. We have developed a system with which you can create a CE-compliant variant from your existing technical documentation. With the help of the validated software solution, you can implement this independently and make a new product file for a class IIb medical device ready for documentation within six weeks. Guaranteed &#8211; because we assure you of the compliance of the technical documentation.<\/p>\n<p>In this way, you efficiently accelerate the approval of your medical device despite the new situation.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-85b3d8d408f80152e13fe296657fc778\">\n.flex_column.av-bcmscg-85b3d8d408f80152e13fe296657fc778{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-85b3d8d408f80152e13fe296657fc778 av_one_fourth  avia-builder-el-11  el_after_av_three_fourth  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><div  class='av_promobox av-kp80ztk9-582c2991aa6f341d0e489c47e12b6ef4 avia-button-no  avia-builder-el-12  avia-builder-el-no-sibling '><div class='avia-promocontent'><p>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-2mxdta-61998394f6518e62259025c27425f4fd\">\n.av_font_icon.av-2mxdta-61998394f6518e62259025c27425f4fd .av-icon-char{\nfont-size:40px;\nline-height:40px;\n}\n<\/style>\n<span  class='av_font_icon av-2mxdta-61998394f6518e62259025c27425f4fd avia_animate_when_visible av-icon-style- avia-icon-pos-left av-no-color avia-icon-animate'><span class='av-icon-char' aria-hidden='true' data-av_icon='\ue80b' data-av_iconfont='entypo-fontello' ><\/span><\/span><\/p>\n<p><span style=\"color: #ffffff\">Do you have a question? Contact us!<\/span><\/p>\n<p><span style=\"color: #ffffff\">We look forward to <a style=\"color: #ffffff\" href=\"https:\/\/www.riskmanager.net\/en\/services\/service-kontakt\/\">hearing from you.<\/a><\/span><\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><\/div><div id='av_section_4'  class='avia-section av-3meicu-d8495e3eb4ff49e05084cd0b2b2ee015 main_color avia-section-default avia-no-border-styling  avia-builder-el-14  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7297'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-bcmscg-b7af1a97b142497931a61a322e892d04\">\n.flex_column.av-bcmscg-b7af1a97b142497931a61a322e892d04{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-bcmscg-b7af1a97b142497931a61a322e892d04 av_four_fifth  avia-builder-el-15  avia-builder-el-no-sibling  first flex_column_div av-zero-column-padding  '     ><article  class='iconbox iconbox_left av-kp6yerls-7f24d6dc747940ccbc4393e2d1612054  avia-builder-el-16  avia-builder-el-no-sibling '  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/BlogPosting\" itemprop=\"blogPost\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Our Succes Story\"><a href='https:\/\/www.riskmanager.net\/loesung\/referenzen\/#mst-instrumente' title='Our Succes Story'  target=\"_blank\"  rel=\"noopener noreferrer\" class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue81f' data-av_iconfont='entypo-fontello'><\/a><h3 class='iconbox_content_title '  itemprop=\"headline\" ><a href='https:\/\/www.riskmanager.net\/loesung\/referenzen\/#mst-instrumente' title='Our Succes Story'  target=\"_blank\"  rel=\"noopener noreferrer\">Our Succes Story<\/a><\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>How we were able to help MST-Instrumente GmbH save labour and time in processing according to IEC 60601-1? <a href=\"https:\/\/www.riskmanager.net\/en\/loesung\/referenzen\/#mst-instrumente\">Read more<\/a> about our shared history here:<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><\/div>\n<\/p>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e\">\n.avia-section.av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/10\/shutterstock_270633650-min-scaled.jpg);\nbackground-position:50% 50%;\nbackground-attachment:scroll;\nmargin-top:5px;\nmargin-bottom:0px;\n}\n.avia-section.av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e .av-section-color-overlay{\nopacity:0.8;\nbackground-color:#5b5b5b;\n}\n<\/style>\n<div id='av_section_5'  class='avia-section av-kkwbkig3-34a6a81ef4cf1354012a23a3fa51958e alternate_color avia-section-default avia-no-border-styling  avia-builder-el-17  el_after_av_section  avia-builder-el-last  avia-full-stretch avia-bg-style-scroll av-section-color-overlay-active container_wrap fullsize'  data-section-bg-repeat='stretch'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-7297'><div class='entry-content-wrapper clearfix'>\n<div  class='av_promobox av-kp6yhpxv-949aa9c1cab2b6db6526b0caec43eb27 avia-button-yes  avia-builder-el-18  avia-builder-el-no-sibling '><div class='avia-promocontent'><p>Would you like to get to know the validated approval accelerator directly free of charge? Sign up for a 30-day TRIAL.<\/p>\n<\/div><div  class='avia-button-wrap av-kp6yhpxv-697838aa8864b36a4fb4d25cd7a6c840-wrap avia-button-right '><a href='https:\/\/www.riskmanager.net\/en\/services\/test-now\/'  class='avia-button av-kp6yhpxv-697838aa8864b36a4fb4d25cd7a6c840 av-link-btn avia-icon_select-no avia-size-large avia-position-right avia-color-theme-color'  target=\"_blank\"  rel=\"noopener noreferrer\"  aria-label=\"Test now for free\"><span class='avia_iconbox_title' >Test now for free<\/span><\/a><\/div><\/div>\n\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":344,"featured_media":7279,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[17],"tags":[],"class_list":["post-7297","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-en"],"_links":{"self":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7297","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/users\/344"}],"replies":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/comments?post=7297"}],"version-history":[{"count":7,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7297\/revisions"}],"predecessor-version":[{"id":7313,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/posts\/7297\/revisions\/7313"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media\/7279"}],"wp:attachment":[{"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/media?parent=7297"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/categories?post=7297"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.riskmanager.net\/en\/wp-json\/wp\/v2\/tags?post=7297"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}