{"id":3551,"date":"2025-05-05T12:59:59","date_gmt":"2025-05-05T12:59:59","guid":{"rendered":"https:\/\/cmcmedicaldevices.com\/?p=3551"},"modified":"2025-05-05T12:59:59","modified_gmt":"2025-05-05T12:59:59","slug":"switzerland-plans-new-pathway-for-non-eu-medical-devices","status":"publish","type":"post","link":"https:\/\/cmcmedicaldevices.com\/es\/switzerland-plans-new-pathway-for-non-eu-medical-devices\/","title":{"rendered":"Switzerland plans new pathway for non-EU medical devices"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container has-pattern-background has-mask-background 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:1248px;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_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:20px;--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-text fusion-text-1\"><p>Switzerland is preparing to introduce a more flexible regulatory framework to strengthen the supply of medical devices in its market. <span style=\"background-color: rgba(0, 0, 0, 0);\">The <b>Federal Council<\/b> intends to establish a legal basis for granting market access, under justified conditions, to devices that do not bear CE marking but comply with <b>internationally recognized regulatory systems<\/b>.<\/span><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_74 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Alternar tabla de contenidos\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/cmcmedicaldevices.com\/es\/switzerland-plans-new-pathway-for-non-eu-medical-devices\/#A_shift_in_Swiss_regulatory_strategy\" >A shift in Swiss regulatory strategy<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/cmcmedicaldevices.com\/es\/switzerland-plans-new-pathway-for-non-eu-medical-devices\/#Preparing_for_the_evolving_Swiss_market\" >Preparing for the evolving Swiss market<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/cmcmedicaldevices.com\/es\/switzerland-plans-new-pathway-for-non-eu-medical-devices\/#The_role_of_the_Swiss_authorised_representative_CH-REP\" >The role of the Swiss authorised representative (CH-REP)<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"A_shift_in_Swiss_regulatory_strategy\"><\/span>A shift in Swiss regulatory strategy<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>This move reflects a strategic effort to <strong>reduce dependency on the European Union\u2019s regulatory framework<\/strong>, especially following the absence of a fully functioning Mutual Recognition Agreement (MRA). By exploring <strong>alternative compliance routes<\/strong>, Switzerland aims to <strong>prevent supply shortages<\/strong> and maintain <strong>patient safety<\/strong>, even in the absence of EU-specific conformity.<\/p>\n<p>The future framework would enable access to <strong>non-CE-marked medical devices<\/strong> in <strong>limited and justified cases<\/strong>, based on compliance with global standards. While the criteria and systems to be recognized have not been officially detailed, the direction points toward <strong>increased regulatory flexibility for non-EU manufacturers<\/strong>. In parallel, the Federal Council also foresees the possibility of delegating conformity assessments to <strong>private, accredited bodies<\/strong> to ensure continued oversight of safety and performance.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"Preparing_for_the_evolving_Swiss_market\"><\/span>Preparing for the evolving Swiss market<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Manufacturers outside the EU may consider this development an opportunity to access the Swiss market through new pathways. To stay aligned with regulatory expectations, companies should <strong>monitor ongoing updates<\/strong> from the Swiss authorities, <strong>assess their current documentation<\/strong> against international benchmarks, and <strong>identify product lines<\/strong> that could potentially benefit from the upcoming provisions.<\/p>\n<p>Strategically planning for this regulatory evolution will allow manufacturers to <strong>anticipate requirements<\/strong>, <strong>adapt internal processes<\/strong>, and approach market entry in Switzerland with greater confidence and readiness.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_role_of_the_Swiss_authorised_representative_CH-REP\"><\/span>The role of the Swiss authorised representative (CH-REP)<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Non-Swiss manufacturers placing medical devices on the Swiss market are required to appoint a Swiss authorised representative (CH-REP). This entity acts as the official point of contact with Swiss authorities and is responsible for ensuring compliance with national requirements on labelling, vigilance, and technical documentation availability.<\/p>\n<p>This obligation remains valid regardless of the regulatory framework under which the device is approved and continues to apply in the context of the planned legal changes.<\/p>\n<\/div><div style=\"text-align:center;\"><a class=\"fusion-button button-flat fusion-button-default-size button-default fusion-button-default button-1 fusion-button-default-span fusion-button-default-type\" style=\"--button_margin-top:10px;--button_margin-bottom:10px;\" target=\"_blank\" rel=\"noopener noreferrer\" href=\"https:\/\/cmcmedicaldevices.com\/services\/representation-switzerland\/\"><span class=\"fusion-button-text\">Learn more about the CH-REP<\/span><\/a><\/div><div class=\"fusion-image-element \" style=\"text-align:center;--awb-max-width:600px;--awb-caption-title-font-family:var(--h2_typography-font-family);--awb-caption-title-font-weight:var(--h2_typography-font-weight);--awb-caption-title-font-style:var(--h2_typography-font-style);--awb-caption-title-size:var(--h2_typography-font-size);--awb-caption-title-transform:var(--h2_typography-text-transform);--awb-caption-title-line-height:var(--h2_typography-line-height);--awb-caption-title-letter-spacing:var(--h2_typography-letter-spacing);\"><span class=\" fusion-imageframe imageframe-none imageframe-1 hover-type-none\"><img decoding=\"async\" width=\"2560\" height=\"1465\" alt=\"Switzerland moves toward international regulatory \" title=\"Switzerland moves toward international regulatory\" src=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory-.jpg\" class=\"img-responsive wp-image-3549\" srcset=\"https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory--200x114.jpg 200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory--400x229.jpg 400w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory--600x343.jpg 600w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory--800x458.jpg 800w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory--1200x687.jpg 1200w, https:\/\/cmcmedicaldevices.com\/wp-content\/uploads\/2025\/05\/Switzerland-moves-toward-international-regulatory-.jpg 2560w\" sizes=\"(max-width: 640px) 100vw, 1200px\" \/><\/span><\/div><\/div><\/div><\/div><\/div>\n\n\n<div class=\"kk-star-ratings kksr-auto kksr-align-center kksr-valign-bottom\"\n    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