{"id":11307,"date":"2024-02-09T18:22:18","date_gmt":"2024-02-10T00:22:18","guid":{"rendered":"https:\/\/casusconsulting.com\/?p=11307"},"modified":"2024-04-08T09:54:20","modified_gmt":"2024-04-08T14:54:20","slug":"swissdamed-registration-database-postponed-new-release-date","status":"publish","type":"post","link":"https:\/\/casusconsulting.com\/swissdamed-registration-database-postponed-new-release-date\/","title":{"rendered":"&#8216;swissdamed&#8217; Registration Database: Launch date pushed to 2nd Half 2024"},"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:35px\" 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-cbab17b7-c1df-4e01-a9bb-ecdd8b286da1\" 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\/swissdamed-registration-database-postponed-new-release-date\/#0-background->Background<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/swissdamed-registration-database-postponed-new-release-date\/#1-the-updated-timing->The Updated Timing<\/a><\/li><li><a href=https:\/\/casusconsulting.com\/swissdamed-registration-database-postponed-new-release-date\/#2-further-reading->Further Reading<\/a><\/li><\/ul><\/div><\/div><\/div>\n\n\n<div style=\"height:5px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<p>Swissmedic published an update to the Swissdamed launch date.<\/p>\n\n\n\n<h2 class=\"wp-block-heading has-black-color has-text-color has-link-color has-large-font-size wp-elements-4d18caa4f7819ac8c5eff2ed3d77828a\" id=\"0-background-\"><strong>Background<\/strong><\/h2>\n\n\n\n<p>As reported previously, Swissmedic is launching a new registration database called \u2018swissdamed\u2019. It will house <span class=\"tooltip tooltip-txt\" data-tooltip=\"Economic Operators are defined in the MedDO\/IvDO as: manufacturers, authorized representatives, importers, and distributors. However, distributors are not required to register in swissdamed. Only manufacturers, system\/procedure pack producers, authorized representatives, and importers are required to register in swissdamed.\" data-position=\"top\">Economic Operator<\/span>\n and medical device information.<\/p>\n\n\n\n<p>The reason it is necessary is because of the lapsed <span class=\"tooltip tooltip-txt\" data-tooltip=\"This is a Mutual Recognition Agreement (MRA) between Switzerland and the EU, allowing for free movement of goods between the two markets. The current MRA only refers to the old Directives. The MDR\/IVDR are not yet covered, i.e., after the dates of application for each Regulation, the MRA was no longer valid and Switzerland was considered a &#039;third&#039; country when it comes to medical devices. An updated or new agreement is needed for continued free movement of medical devices and IVDs.\" data-position=\"top\">Mutual Recognition Agreement<\/span>\n between Europe and Switzerland, for medical devices. As a result, Swissmedic no longer has Competent Authority access to EUDAMED. Therefore, a Swiss equivalent to EUDAMED is being developed.<\/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-9a52dd7162dbe1baa6a1f1f0cba44dd1\" id=\"1-the-updated-timing-\"><strong>The Updated Timing<\/strong><\/h2>\n\n\n\n<p>The Swissdamed Economic Operator module was supposed to be available in early 2024, with the Medical Device module becoming available in the summer of 2024. <\/p>\n\n\n\n<p>However, Swissmedic published new release dates, postponing its launch. The new timing is:<\/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>Economic Operator module now available \u201cin the 2<sup>nd<\/sup> half of 2024\u201d.<\/li>\n\n\n\n<li>The Medical Device module to follow \u201c4 months after\u201d the Economic Operator module goes live.<\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<p>The reason cited is related to the continued development of IT infrastructure. Until then, swissdamed will be delayed.<\/p>\n\n\n\n<p>As a reminder, in addition to swissdamed going live, the Medical Device &amp; IVD Ordinances must be updated, in order to make its use mandatory.<\/p>\n\n\n\n<p>Until then, manufacturers should continue to follow the current registration requirements.<\/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-02536f9e4b5b1e1647068c2dd4db104a\" id=\"2-further-reading-\"><strong>Further Reading<\/strong><\/h2>\n\n\n\n<p>You may also be interested in:<\/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><a href=\"https:\/\/casusconsulting.com\/services\/switzerland\/device-registration\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Switzerland Medical Device &amp; IVD Registration Requirements<\/strong><\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/casusconsulting.com\/what-is-a-chrn\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Swiss Single Registration Number (CHRN): What is it, who needs it, how to get one<\/strong><\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/casusconsulting.com\/systems-procedure-packs-and-kits-requirements\/#19-switzerland-requirements-\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>Switzerland System\/Procedure Pack Requirements<\/strong><\/a><\/li>\n<\/ul>\n<\/div><\/div>\n<\/div>\n<\/div>\n\n\n\n<div style=\"height:30px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n<\/div><\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Swissdamed is being postponed, due to continued on work on the IT infrastructure. Find out the new &#8216;go-live&#8217; dates and when its use will become mandatory.<\/p>\n","protected":false},"author":4,"featured_media":11310,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ub_ctt_via":"","footnotes":""},"categories":[4],"tags":[17,55],"cp_meta_data":{"_edit_lock":["1712588065:4"],"_tve_js_modules_gutenberg":["a:1:{i:0;s:9:\"gutenberg\";}"],"_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:\"ffa07825a2\";}"],"_wpb_vc_js_status":["false"],"_thumbnail_id":["11310"],"_genesis_title":["Feb 2024: Swissdamed Database Postponed"],"_genesis_description":["Swissdamed is being postponed, due to continued on work on the IT infrastructure. Find out the new \u2018go&#x2d;live\u2019 dates and when its use will become mandatory."],"mfn-meta-seo-title":["Feb 2024: Swissdamed Database Postponed"],"mfn-meta-seo-description":["Swissdamed is being postponed, due to continued on work on the IT infrastructure. Find out the new 'go-live' dates and when its use will become mandatory."],"_wp_old_slug":["swissdamed-registration-database-launch-date-pushed-to-2nd-half-2024"],"_cmplz_scanned_post":["1"],"_primary_term_category":["4"]},"featured_image_src":"https:\/\/casusconsulting.com\/wp-content\/uploads\/2024\/02\/Swissdamed-Registration-Database-New-Release-Dates-scaled.jpg","author_info":{"display_name":"annmarie","author_link":"https:\/\/casusconsulting.com\/author\/annmarie\/"},"_links":{"self":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/11307"}],"collection":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/comments?post=11307"}],"version-history":[{"count":6,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/11307\/revisions"}],"predecessor-version":[{"id":11697,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/posts\/11307\/revisions\/11697"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media\/11310"}],"wp:attachment":[{"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/media?parent=11307"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/categories?post=11307"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/casusconsulting.com\/wp-json\/wp\/v2\/tags?post=11307"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}