{"id":5128,"date":"2024-11-05T08:50:22","date_gmt":"2024-11-05T08:50:22","guid":{"rendered":"https:\/\/customscomplete.com\/?p=5128"},"modified":"2024-11-21T11:06:29","modified_gmt":"2024-11-21T11:06:29","slug":"expedition-de-dispositifs-medicaux-pour-traitement-et-essais","status":"publish","type":"post","link":"https:\/\/customscomplete.com\/fr\/medical-devices-shipping-for-processing-and-trials\/","title":{"rendered":"Exp\u00e9dition de dispositifs m\u00e9dicaux pour traitement et essais"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5128\" class=\"elementor elementor-5128\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ba538d7 elementor-section-content-middle elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ba538d7\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-58e2ebf\" data-id=\"58e2ebf\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-abaa949 elementor-widget elementor-widget-heading\" data-id=\"abaa949\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">MEDICAL DEVICES SHIPPING <\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-75d4284 elementor-widget elementor-widget-text-editor\" data-id=\"75d4284\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Shipping medical devices<\/strong> for processing and trials involves a complex regulatory framework, particularly under the EU\u2019s <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=celex%3A32017R0745\"><strong>Medical Device Regulation (MDR)<\/strong> 2017\/745<\/a> and <strong>In Vitro Diagnostic Medical Device Regulation (IVDR)<\/strong> 2017\/746. These regulations impose strict <strong>requirements<\/strong> on relabeling, repackaging, and translating device information to ensure compliance, which is essential for smooth cross-border <strong>medical device shipping<\/strong>.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1aab143 elementor-toc--minimized-on-tablet elementor-widget elementor-widget-table-of-contents\" data-id=\"1aab143\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;exclude_headings_by_selector&quot;:[],&quot;marker_view&quot;:&quot;bullets&quot;,&quot;icon&quot;:{&quot;value&quot;:&quot;fas fa-genderless&quot;,&quot;library&quot;:&quot;fa-solid&quot;},&quot;headings_by_tags&quot;:[&quot;h2&quot;,&quot;h3&quot;,&quot;h4&quot;,&quot;h5&quot;,&quot;h6&quot;],&quot;no_headings_message&quot;:&quot;No headings were found on this page.&quot;,&quot;minimize_box&quot;:&quot;yes&quot;,&quot;minimized_on&quot;:&quot;tablet&quot;,&quot;hierarchical_view&quot;:&quot;yes&quot;,&quot;min_height&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;min_height_tablet&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]},&quot;min_height_mobile&quot;:{&quot;unit&quot;:&quot;px&quot;,&quot;size&quot;:&quot;&quot;,&quot;sizes&quot;:[]}}\" data-widget_type=\"table-of-contents.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-toc__header\">\n\t\t\t\t\t\t<h4 class=\"elementor-toc__header-title\">\n\t\t\t\tIn this blog we will go through the following topics:\t\t\t<\/h4>\n\t\t\t\t\t\t\t\t\t\t<div class=\"elementor-toc__toggle-button elementor-toc__toggle-button--expand\" role=\"button\" tabindex=\"0\" aria-controls=\"elementor-toc__1aab143\" aria-expanded=\"true\" aria-label=\"Open table of contents\"><i aria-hidden=\"true\" class=\"fas fa-chevron-down\"><\/i><\/div>\n\t\t\t\t<div class=\"elementor-toc__toggle-button elementor-toc__toggle-button--collapse\" role=\"button\" tabindex=\"0\" aria-controls=\"elementor-toc__1aab143\" aria-expanded=\"true\" aria-label=\"Close table of contents\"><i aria-hidden=\"true\" class=\"fas fa-chevron-up\"><\/i><\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<div id=\"elementor-toc__1aab143\" class=\"elementor-toc__body\">\n\t\t\t<div class=\"elementor-toc__spinner-container\">\n\t\t\t\t<i class=\"elementor-toc__spinner eicon-animation-spin eicon-loading\" aria-hidden=\"true\"><\/i>\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9e248c3 elementor-widget elementor-widget-image\" data-id=\"9e248c3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/customscomplete.com\/wp-content\/uploads\/elementor\/thumbs\/Medical-Device-Shipping-scaled-qwlp14wd9eyqao46akpv6irfi7sqjpyrhxjxmdihjm.jpg\" title=\"Medical Devices Shipping\" alt=\"Medical Devices Shipping\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c113461 elementor-widget elementor-widget-heading\" data-id=\"c113461\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">MDR\/IVDR Article 16\n\n\n\n\n\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-dada352 elementor-widget elementor-widget-text-editor\" data-id=\"dada352\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>The EU\u2019s <strong>Article 16<\/strong> of MDR\/IVDR defines actions that distributors and importers can take\u2014such as relabeling or repackaging\u2014without assuming manufacturer obligations, provided they meet regulatory compliance standards. For businesses involved in <strong>medical device shipping<\/strong>, adhering to these guidelines is critical for effective and compliant distribution.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-238c653 elementor-widget elementor-widget-heading\" data-id=\"238c653\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Activities Allowed Under Article 16<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5f121c elementor-widget elementor-widget-text-editor\" data-id=\"b5f121c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><strong>Translation of Device Information<\/strong>: Importers and distributors may translate the manufacturer\u2019s information, including labels and instructions, to meet language requirements in EU Member States.<\/li><li><strong>Packaging Modifications<\/strong>: To align with market needs, companies may adjust outer packaging, such as resizing for specific healthcare requirements. These adjustments are allowed as long as they maintain the device\u2019s compliance.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-949b280 elementor-widget elementor-widget-heading\" data-id=\"949b280\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Repackaging and Relabeling<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6528088 elementor-widget elementor-widget-text-editor\" data-id=\"6528088\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>To meet <strong>Article 16 standards<\/strong>, importers and distributors involved in <strong>shipping medical devices<\/strong> must ensure:<\/p><ol><li><strong>Notification<\/strong>: Notify the manufacturer and the competent authority 28 days before introducing a relabeled or repackaged device. This notification should include samples to verify compliance.<\/li><li><strong>Certification<\/strong>: Obtain certification from a notified body to confirm compliance with MDR\/IVDR standards, especially for repackaging and relabeling.<\/li><li><strong>UDI and Traceability<\/strong>: Preserve the device\u2019s <strong>Unique Device Identification (UDI)<\/strong> and <strong>traceability<\/strong> to maintain regulatory standards and safeguard essential information.<\/li><li><strong>Quality Management System (QMS)<\/strong>: Implement a <strong>QMS<\/strong> to document and trace all procedures, supporting field safety and post-market surveillance.<\/li><\/ol>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f0847c0 elementor-widget elementor-widget-heading\" data-id=\"f0847c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Additional Considerations for Medical Devices Shipping <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b5901c4 elementor-widget elementor-widget-text-editor\" data-id=\"b5901c4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<ul><li><strong>Streamlined Notifications<\/strong>: Notify only once for initial market introduction; batch-by-batch notifications aren\u2019t necessary unless significant changes are made.<\/li><li><strong>Post-Market Obligations<\/strong>: Continued communication with manufacturers and authorities, even if relabeling or repackaging has ceased, enhances transparency for post-market monitoring.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cee04c9 elementor-widget elementor-widget-heading\" data-id=\"cee04c9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h3 class=\"elementor-heading-title elementor-size-default\">Practical Example<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d412342 elementor-widget elementor-widget-text-editor\" data-id=\"d412342\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>An importer may receive syringes in bulk and repackage them into smaller batches to meet local healthcare provider needs. Provided the primary sterile packaging remains intact, this practice aligns with <strong>Article 16<\/strong> without adding regulatory obligations.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c018512 elementor-widget elementor-widget-text-editor\" data-id=\"c018512\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><strong>Shipping medical devices<\/strong> within the EU requires a comprehensive understanding of <strong>MDR\/IVDR regulations<\/strong>.<\/p><p>At\u00a0<a href=\"https:\/\/customscomplete.com\/contact-us\/\"><strong>Customs Complete<\/strong><\/a>, we specialize in compliant <strong>medical device shipping<\/strong> to support efficient and effective cross-border distribution. Contact us for assistance with your <strong>logistics<\/strong> and <strong>regulatory compliance<\/strong> needs.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-20dd755 elementor-widget elementor-widget-heading\" data-id=\"20dd755\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Get in touch<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c51b976 elementor-widget elementor-widget-wpforms\" data-id=\"c51b976\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container \" id=\"wpforms-198\"><form id=\"wpforms-form-198\" class=\"wpforms-validate wpforms-form\" data-formid=\"198\" method=\"post\" 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class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"198\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/customscomplete.com\/fr\/wp-json\/wp\/v2\/posts\/5128\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-198\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"SEND MESSAGE\" aria-live=\"assertive\" value=\"wpforms-submit\">SEND MESSAGE<\/button><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>L'exp\u00e9dition de dispositifs m\u00e9dicaux \u00e0 des fins de traitement et d'essais implique un cadre r\u00e9glementaire complexe, en particulier en vertu du r\u00e8glement sur les dispositifs m\u00e9dicaux (MDR) 2017\/745 et du r\u00e8glement sur les dispositifs m\u00e9dicaux de diagnostic in vitro (IVDR) 2017\/746 de l'UE. Ces r\u00e8glements imposent des exigences strictes en mati\u00e8re de r\u00e9\u00e9tiquetage, de reconditionnement et de traduction des informations relatives aux dispositifs afin de garantir la conformit\u00e9, ce qui est essentiel pour une exp\u00e9dition transfrontali\u00e8re fluide des dispositifs m\u00e9dicaux.<\/p>","protected":false},"author":1,"featured_media":5130,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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