{"id":11491,"date":"2024-03-13T18:47:20","date_gmt":"2024-03-13T23:47:20","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=11491"},"modified":"2024-04-05T17:49:17","modified_gmt":"2024-04-05T22:49:17","slug":"switzerland-eu-mutual-recognition-negotiations-commence","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/","title":{"rendered":"Switzerland-EU Mutual Recognition: New Negotiation Discussions Underway"},"content":{"rendered":"\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-3 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:5%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:85%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p><p><\/p><script src=\"https:\/\/9931674141ca41baa2023404fd2333a2.js.ubembed.com\" async=\"\"><\/script><\/p>\n\n\n<div class=\"wp-block-ub-table-of-contents-block ub_table-of-contents\" data-showtext=\"show\" data-hidetext=\"hide\" data-scrolltype=\"auto\" id=\"ub_table-of-contents-b77ae022-4350-4af6-8b37-72af05b6268b\" data-initiallyhideonmobile=\"false\"\n                    data-initiallyshow=\"true\"><div class=\"ub_table-of-contents-header-container\"><div class=\"ub_table-of-contents-header\">\n                    <div class=\"ub_table-of-contents-title\">Table of Contents<\/div><\/div><\/div><div class=\"ub_table-of-contents-extra-container\"><div class=\"ub_table-of-contents-container ub_table-of-contents-1-column \"><ul><li><a href=https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/#0-the-purpose-of-the-negotiations->The Purpose of the negotiations<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/#1-why-is-this-important-to-the-medical-device-industry->Why is this important to the medical device industry?<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/#2-what%E2%80%99s-next->What\u2019s next?<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/switzerland-eu-mutual-recognition-negotiations-commence\/#3-further-reading->Further Reading<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<p>The Swiss Federal Council and EU Commission have each approved their final negotiating mandates. As a result, this month the EU and Switzerland will resume formal negotiations to try and restore mutual recognition.<\/p>\n\n\n\n<p>Switzerland\u2019s update is available: <strong><a href=\"https:\/\/www.admin.ch\/gov\/en\/start\/documentation\/media-releases.msg-id-100342.html\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><\/strong><\/p>\n\n\n\n<p>The EU\u2019s update is available: <strong><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/ip_24_1405\" target=\"_blank\" rel=\"noreferrer noopener\">HERE<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:10px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-ddf6402ca260d80a4da0804da5f3a264\" id=\"0-the-purpose-of-the-negotiations-\"><strong>The Purpose of the negotiations<\/strong><\/h2>\n\n\n\n<p>It is to try again, to put an updated agreement in place. This would allow continued mutual recognition between the two regions and allow Switzerland to remain part of the European Single Market.<\/p>\n\n\n\n<p>The previous discussions broke down over larger political issues: what the EU felt was an &#8216;unbalanced playing field\u2019 and Swiss citizens unwilling to concede on certain points, such as immigration. <\/p>\n\n\n\n<p>As a result, while the existing Swiss-EU agreements could remain &#8216;as is&#8217;, the EU would not update the agreements to account for amended\/replaced legislations. Nor would they put any new agreements in place. <\/p>\n\n\n\n<p>For more background, please read the EU Parliament Briefing:&nbsp;<strong><a href=\"https:\/\/www.europarl.europa.eu\/RegData\/etudes\/BRIE\/2021\/696174\/EPRS_BRI(2021)696174_EN.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">EU-Swiss trade relations and the institutional framework agreement<\/a><\/strong><\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-db7f96c82afb660599959c0f5f738c5e\" id=\"1-why-is-this-important-to-the-medical-device-industry-\"><strong>Why is this important to the medical device industry?<\/strong><\/h2>\n\n\n\n<p>One of the first industries to be impacted by lack of a new agreement was the medical device sector. With the EU unwilling to update the Mutual Recognition Agreement to cover the MDR and IVDR, Switzerland was left a third country on their respective application dates.<\/p>\n\n\n\n<p>Measures had to be put quickly into place to cover the gaps, such as:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li>Non-Swiss manufacturers had to scramble to appoint a Swiss Authorized Representative and Swiss manufacturers to appoint an EU Authorized Representative<\/li>\n\n\n\n<li>Switzerland began developing its own EUDAMED-like registration database (\u2018swissdamed\u2019)<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>If the end result of the new negotiations is &#8220;approval&#8221; on both sides, then Switzerland once again becomes part of the EU Single Market. The above measures would then no longer be needed.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-401bcbb1938b71d90b92f57bde6bd7c8\" id=\"2-what%E2%80%99s-next-\"><strong>What\u2019s next?<\/strong><\/h2>\n\n\n\n<p>The objective is to finalize negotiations in 2024, after which it will go up for vote.<\/p>\n\n\n\n<p>Some of the main points of contention, which caused the previous agreement to collapse, were around immigration, welfare, and wage protection. While the outlook in Switzerland is more favorable than it has been in previous years, these still appear to remain as \u2018sticking\u2019 points to implementing a new agreement. <\/p>\n\n\n\n<p>For example, an excerpt from the November 30, 2023 <strong><a href=\"https:\/\/www.swiss-medtech.ch\/en\/news\/now-time-bilaterals-iii\" target=\"_blank\" rel=\"noreferrer noopener\">Swiss Population Survey on the EU Negotiating Mandate<\/a><\/strong> (informal English translation):<\/p>\n\n\n\n<p class=\"has-background\" style=\"background-color:#f8f8f8\">\u201cThe statement that immigration from the EU is becoming a major burden on our social welfare system enjoys the greatest support (62% agree\/strongly agree), followed by the arguments that this same immigration from the EU is driving up rents and property prices (61%) and that Switzerland has lost control over immigration (52%). However, in view of this criticism, only a clear minority of respondents agree that Switzerland is not at all dependent on the bilateral agreements (30% strongly\/somewhat agree).\u201d<\/p>\n\n\n\n<p>That said, the Swiss Federal Council has been working hard to lobby the new negotiating terms internally, within the Swiss cantons (states). <\/p>\n\n\n\n<p>The EU wants these topics addressed to provide, what they feel, is fairer reciprocity. The EU\u2019s <strong><a href=\"https:\/\/ec.europa.eu\/commission\/presscorner\/detail\/en\/QANDA_24_1406\" target=\"_blank\" rel=\"noreferrer noopener\">FAQs<\/a><\/strong> state that all elements of the package have to advance together, i.e., both the controversial and non-controversial agreements are considered part of a single package.<\/p>\n\n\n\n<p>Will Switzerland rejoin the European market, or stay cut out? At this time, it is hard to predict. <\/p>\n\n\n\n<p>Stay tuned for updates. Casus will be monitoring the negotiations as they progress.<\/p>\n\n\n\n<div style=\"height:15px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-055f28bc65e3af7c227bfb08b1fbf6be\" id=\"3-further-reading-\"><strong>Further Reading<\/strong><\/h2>\n\n\n\n<p>You may also be interested in the following topics:<\/p>\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-2 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:1%\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:99%\">\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container is-layout-constrained wp-block-group-is-layout-constrained\">\n<ul>\n<li><strong><a href=\"https:\/\/casusconsulting.com\/swissdamed-registration-database-postponed-new-release-date\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u2018swissdamed\u2019 Registration Database Timing<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/in-country-representative-labeling-requirements\/\" target=\"_blank\" rel=\"noreferrer noopener\">Labeling Requirements for the EU, UK and Swiss Representative<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/services\/switzerland\/device-registration\/\" target=\"_blank\" rel=\"noreferrer noopener\">Swiss Registration Requirements (while \u2018swissdamed\u2019 is delayed)<\/a><\/strong><\/li>\n\n\n\n<li><strong><a href=\"https:\/\/casusconsulting.com\/services\/switzerland\/steps-to-market\/\" target=\"_blank\" rel=\"noreferrer noopener\">Switzerland Steps to Market<\/a><\/strong><\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p><\/p>\n\n\n\n<div style=\"height:35px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>This month the Swiss Federal Council and EU Commission will resume formal negotiations; if successful, this will restore mutual recognition for medical devices. Find out the details here. <\/p>\n","protected":false},"author":4,"featured_media":11492,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[4],"tags":[12,8,55],"cp_meta_data":{"_edit_lock":["1712357358:4"],"_thumbnail_id":["11492"],"_edit_last":["4"],"hefo_before":["0"],"hefo_after":["0"],"cmplz_hide_cookiebanner":[""],"mfn-post-hide-content":["0"],"mfn-post-layout":["no-sidebar"],"mfn-post-sidebar":["0"],"mfn-post-sidebar2":["0"],"mfn-post-template":["intro"],"mfn-post-slider":["0"],"mfn-post-slider-layer":["0"],"mfn-post-full-width":["0"],"mfn-post-hide-title":["0"],"mfn-post-remove-padding":["0"],"mfn-post-intro":["a:1:{s:9:\"post-meta\";s:1:\"1\";}"],"mfn-post-hide-image":["0"],"jbp-single-post":["a:3:{s:8:\"override\";s:1:\"0\";s:22:\"single_template_custom\";s:1:\"0\";s:5:\"nonce\";s:10:\"6e08bddd4f\";}"],"_wpb_vc_js_status":["false"],"_genesis_title":["March 2024: EU&#x2d;Swiss Negotiations Commence"],"_genesis_description":["This month the Swiss Federal Council and EU Commission will resume formal negotiations; if successful, this will restore mutual recognition for medical devices. 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