{"id":21844,"date":"2022-07-25T13:17:43","date_gmt":"2022-07-25T11:17:43","guid":{"rendered":"http:\/\/www.thema-med.eu\/?page_id=21844"},"modified":"2025-07-10T14:27:30","modified_gmt":"2025-07-10T12:27:30","slug":"faq-2","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/faq-2\/","title":{"rendered":"FAQ"},"content":{"rendered":"<p><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 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\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-one-full fusion-column-first fusion-column-last\" style=\"--awb-bg-blend:overlay;--awb-bg-size:cover;--awb-margin-top:0px;--awb-margin-bottom:0px;\"><div class=\"fusion-column-wrapper fusion-flex-column-wrapper-legacy\"><div class=\"fusion-text fusion-text-1\"><h2><strong>UDI in Medical Devices: Obligations, Labelling and Requirements According to MDR (EU) 2017\/745 and IVDR (EU) 2017\/745<\/strong><\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-1 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-1 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-1-post-34407\" class=\"fusion-post-grid post-34407 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices tag-in-vitro-diagnostic-devices tag-ivd-en-2 tag-medical-device-identification tag-medical-device-traceability-en tag-medical-devices-en tag-udi-en-2 tag-udi-ivd-en tag-udi-di-en tag-udi-pi-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-is-the-udi-for-medical-devices-and-ivds-and-what-is-it-for\/\">What is the UDI for Medical Devices and IVDs, and what is it for?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34405\" class=\"fusion-post-grid post-34405 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-is-the-basic-udi-di-and-how-does-it-differ-from-the-udi\/\">What is the Basic UDI-DI and how does it differ from the UDI?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34403\" class=\"fusion-post-grid post-34403 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/which-medical-devices-must-have-a-udi-code\/\">Which medical devices must have a UDI code?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34396\" class=\"fusion-post-grid post-34396 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-are-the-mandatory-deadlines-for-adopting-the-udi-system\/\">What are the mandatory deadlines for adopting the UDI system?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34394\" class=\"fusion-post-grid post-34394 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-is-the-difference-between-udi-code-and-udi-support\/\">What is the difference between UDI code and UDI support?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34387\" class=\"fusion-post-grid post-34387 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/how-should-the-udi-appear-on-the-label-and-packaging-of-the-device\/\">How should the UDI appear on the label and packaging of the device?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34385\" class=\"fusion-post-grid post-34385 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/where-and-how-is-udi-registered-in-eudamed\/\">Where and how is UDI registered in EUDAMED?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34383\" class=\"fusion-post-grid post-34383 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/who-is-responsible-for-affixing-the-udi-code-on-medical-devices-labels-and-packaging\/\">Who is responsible for affixing the UDI code on medical devices, labels and packaging?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34381\" class=\"fusion-post-grid post-34381 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/should-legacy-devices-mdd-aimdd-have-a-udi-code\/\">Should legacy devices (MDD\/AIMDD) have a UDI code?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34378\" class=\"fusion-post-grid post-34378 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/for-which-medical-devices-does-the-mdr-have-specific-udi-requirements\/\">For which medical devices does the MDR have specific UDI requirements?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34376\" class=\"fusion-post-grid post-34376 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-are-the-requirements-for-udi-registration-of-systems-and-procedural-kits\/\">What are the requirements for UDI registration of systems and procedural kits?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-1-post-34374\" class=\"fusion-post-grid post-34374 post type-post status-publish format-standard hentry category-faq-en category-udi-in-medical-devices tag-basic-udi-di-en tag-gs1-en tag-ivd-en-2 tag-ivdr-regulation tag-legacy-devices-en tag-mdr-regulation tag-medical-devices-identification tag-medical-devices-labelling tag-medical-devices-traceability-en tag-medical-devices-udi tag-udi-en-2 tag-udi-code tag-udi-deadlines tag-udi-direct-marking tag-udi-ivd-en tag-udi-labels tag-udi-obligations tag-udi-support tag-udi-vector tag-udi-di-en tag-udi-pi-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2025\/07\/10\/what-is-the-correct-format-of-the-expiry-date-to-be-reported-in-the-udi-vector\/\">What is the correct format of the expiry date to be reported in the UDI vector?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-2\"><h2><strong>Transition to MDR (EU) 2017\/745 Certification<\/strong><\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-2 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-2 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-2 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-2-post-32342\" class=\"fusion-post-grid post-32342 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/is-it-sufficient-to-readjust-existing-technical-documentation\/\">Is it sufficient to readjust existing technical documentation?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32340\" class=\"fusion-post-grid post-32340 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/if-the-regulatory-body-has-approved-the-certification-request-in-the-past-is-it-more-likely-to-approve-it-after-the-transition-to-mdr-eu-2017-745\/\">If the regulatory body has approved the certification request in the past, is it more likely to approve it after the transition to MDR (EU) 2017\/745?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32338\" class=\"fusion-post-grid post-32338 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/if-the-device-had-not-changed-and-never-had-problems-could-it-have-problems-with-mdr-eu-2017-745\/\">If the device had not changed and never had problems, could it have problems with MDR (EU) 2017\/745?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32336\" class=\"fusion-post-grid post-32336 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/is-relying-on-an-external-consultancy-sufficient-to-obtain-ce-certification\/\">Is relying on an external consultancy sufficient to obtain CE certification?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32334\" class=\"fusion-post-grid post-32334 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/is-it-possible-to-obtain-ce-certification-quickly\/\">Is it possible to obtain CE certification quickly?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32332\" class=\"fusion-post-grid post-32332 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/how-much-does-it-help-to-be-iso-13485-certified\/\">How much does it help to be ISO 13485 certified?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-2-post-32330\" class=\"fusion-post-grid post-32330 post type-post status-publish format-standard hentry category-faq-en category-transition-to-mdr-eu-2017-745-certification\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2024\/04\/11\/can-it-happen-that-a-ce-certificate-is-denied-or-withdrawn\/\">Can it happen that a CE certificate is denied or withdrawn?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-3\" style=\"--awb-margin-top:35px;\"><h2>Regulatory update<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-3 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-3 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-3 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-3-post-30285\" class=\"fusion-post-grid post-30285 post type-post status-publish format-standard hentry category-faq-en category-regulatory-update\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-is-meant-by-documents-or-list-of-external-origin\/\">What is meant by documents (or list) of external origin?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-3-post-30304\" class=\"fusion-post-grid post-30304 post type-post status-publish format-standard hentry category-faq-en category-regulatory-update\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/why-is-it-necessary-to-implement-and-manage-the-process-of-compliance-with-standards-laws-and-regulations\/\">Why is it necessary to implement and manage the process of compliance with standards, laws and regulations?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-3-post-30308\" class=\"fusion-post-grid post-30308 post type-post status-publish format-standard hentry category-faq-en category-regulatory-update\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/what-does-the-list-of-documents-of-external-origin-depend-on\/\">What does the list of documents of external origin depend on?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-3-post-30312\" class=\"fusion-post-grid post-30312 post type-post status-publish format-standard hentry category-faq-en category-regulatory-update\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2023\/09\/20\/who-controls-the-updating-of-documents-of-external-origin\/\">Who controls the updating of documents of external origin?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-4\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">Swiss &#8211; Exit: Requirements for marketing Medical Devices in Switzerland<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-4 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-pagination fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-4 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-4 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-pagination fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"1\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-4-post-19709\" class=\"fusion-post-grid post-19709 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/swiss-exit-what-requirements-should-eu-manufacturers-of-medical-devices-satisfy-now\/\">Swiss Exit: what requirements should EU Manufacturers of Medical Devices satisfy now?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-4-post-19712\" class=\"fusion-post-grid post-19712 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/why-is-switzerland-considered-third-country-by-europe\/\">Why is Switzerland considered a Third Country by Europe?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-4-post-19706\" class=\"fusion-post-grid post-19706 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/for-which-medical-devices-is-it-necessary-appoint-ch-rep\/\">For which Medical Devices is it necessary to appoint a Swiss Authorised Representative?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-4-post-19704\" class=\"fusion-post-grid post-19704 post type-post status-publish format-standard hentry category-faq-en category-switzerland-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2021\/12\/14\/do-swiss-rep-and-importers-have-to-register-eudamed\/\">Do Swiss Authorised Representative and Importers of Medical Devices have to register in EUDAMED?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-5\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">IVDR (EU) 2017\/746<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-5 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-5 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-5 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-5-post-15405\" class=\"fusion-post-grid post-15405 post type-post status-publish format-standard hentry category-faq-en category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/transitional-period-can-ivds-be-placed-on-eu-market-after-may-26-2022\/\">Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15403\" class=\"fusion-post-grid post-15403 post type-post status-publish format-standard hentry category-faq-en category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/sell-off-provision-ivdr-2017-746-eu\/\">What is the \u201csell off\u201d provision?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15401\" class=\"fusion-post-grid post-15401 post type-post status-publish format-standard hentry category-faq-en category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/is-it-possible-to-self-certificate-device-in-the-field-of-ivdr-2017-746\/\">Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15397\" class=\"fusion-post-grid post-15397 post type-post status-publish format-standard hentry category-faq-en category-ivdr-faq-es category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/main-chianges-provided-for-in-the-ivdr-2017-746\/\">What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15395\" class=\"fusion-post-grid post-15395 post type-post status-publish format-standard hentry category-faq-en category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/ivdr-2017-746-how-does-affect-quality-management-system\/\">How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15393\" class=\"fusion-post-grid post-15393 post type-post status-publish format-standard hentry category-faq-en category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/when-manufacturers-ivd-have-to-conform-to-ivdr-2017-746\/\">When do Manufacturers of in vitro diagnostic medical devices have to conform to the IVDR (EU) 2017\/746?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-5-post-15391\" class=\"fusion-post-grid post-15391 post type-post status-publish format-standard hentry category-faq-en category-ivdr-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2020\/08\/20\/ivdr-2017-746-regulation-eu\/\">What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017\/746? When does it apply?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-6\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">What will be the impact of MDR (EU) 2017\/745 on EC MDD certificates in &#8216;period of grace&#8217;?<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-6 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-6 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-6 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-6-post-9743\" class=\"fusion-post-grid post-9743 post type-post status-publish format-standard hentry category-faq-en category-mdr-impact-ce-mdd-certificates-period-of-grace\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-is-the-period-of-grace-and-how-can-i-take-advantage-of-it\/\">What is the &#8220;period of grace&#8221; and how can I take advantage of it?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-9741\" class=\"fusion-post-grid post-9741 post type-post status-publish format-standard hentry category-faq-en category-mdr-impact-ce-mdd-certificates-period-of-grace\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-is-the-difference-between-market-surveillance-post-market-surveillance-pms-and-vigilance\/\">What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-9738\" class=\"fusion-post-grid post-9738 post type-post status-publish format-standard hentry category-faq-en category-mdr-impact-ce-mdd-certificates-period-of-grace\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-are-the-mdr-requirements-for-post-market-surveillance-market-surveillance-and-vigilance\/\">What are the MDR requirements for post-market surveillance, market surveillance and vigilance?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-9733\" class=\"fusion-post-grid post-9733 post type-post status-publish format-standard hentry category-faq-en category-mdr-impact-ce-mdd-certificates-period-of-grace\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/what-is-the-post-market-surveillance-system\/\">What is the &#8220;post-market surveillance system&#8221;?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-6-post-9729\" class=\"fusion-post-grid post-9729 post type-post status-publish format-standard hentry category-faq-en category-mdr-impact-ce-mdd-certificates-period-of-grace\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2019\/06\/12\/how-can-i-continue-to-sell-my-devices-after-the-full-implementation-of-mdr\/\">How can I continue to sell my devices after the full implementation of MDR?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-7\" style=\"--awb-margin-top:35px;\"><\/p>\n<h2>How to register radiation-emitting Medical Devices with CDRH<\/h2>\n<p><!-- \/wp:post-content --><\/p>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-7 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-7 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-7 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-3 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-7-post-7827\" class=\"fusion-post-grid post-7827 post type-post status-publish format-standard hentry category-faq-en category-how-to-register-radiation-emitting-medical-devices-with-cdrh-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2018\/08\/29\/what-is-the-accession-number\/\">What is the Accession Number?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-7-post-7821\" class=\"fusion-post-grid post-7821 post type-post status-publish format-standard hentry category-faq-en category-how-to-register-radiation-emitting-medical-devices-with-cdrh-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2018\/08\/29\/which-medical-devices-are-classified-as-electronic-products-that-emit-radiation\/\">Which medical devices are classified as electronic products that emit radiation?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-7-post-7817\" class=\"fusion-post-grid post-7817 post type-post status-publish format-standard hentry category-faq-en category-how-to-register-radiation-emitting-medical-devices-with-cdrh-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2018\/08\/29\/what-does-the-cdrh-do\/\">What does the CDRH do?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-8\" style=\"--awb-margin-top:35px;\"><p><!-- wp:html \/--><\/p>\n<h2>Why CE marking is necessary<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-8 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-8 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-8 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-8-post-7287\" class=\"fusion-post-grid post-7287 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2018\/05\/18\/will-the-ivdr-2017746-affect-the-quality-system-management\/\">How will the IVDR 2017\/746 affect the Quality System Management?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-7279\" class=\"fusion-post-grid post-7279 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2018\/05\/18\/what-does-the-entry-into-force-of-ivdr-2017746-entail-for-manufacturers-of-vitro-diagnostic-medical-devices\/\">What does the entry into force of IVDR 2017\/746 entail for manufacturers of in vitro diagnostic medical devices?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-7266\" class=\"fusion-post-grid post-7266 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2018\/05\/18\/when-will-the-ivdr-2017746-enter-into-force\/\">When will the IVDR 2017\/746 enter into force?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-4253\" class=\"fusion-post-grid post-4253 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/when-is-the-notified-bodys-intervention-needed\/\">When is the Notified Body\u2019s intervention needed?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-4251\" class=\"fusion-post-grid post-4251 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/when-do-have-to-appoint-an-authorized-representative\/\">When do I have to appoint an Authorized Representative?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-4245\" class=\"fusion-post-grid post-4245 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/can-establish-medical-device-risk-class\/\">How can I establish a medical device risk class ?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-8-post-4137\" class=\"fusion-post-grid post-4137 post type-post status-publish format-standard hentry category-faq-en category-why-is-the-ce-marking-required\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/18\/what-is-the-obl-contract\/\">What is the OBL contract?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-9\" style=\"--awb-margin-top:35px;\"><p><!-- wp:html \/--><\/p>\n<h2>What is a regulatory strategy<\/h2>\n<p><!-- \/wp:heading --><\/p>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-9 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-9 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-9 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-3 isotope\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-9-post-4157\" class=\"fusion-post-grid post-4157 post type-post status-publish format-standard hentry category-faq-en category-what-is-a-regulatory-strategy\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/18\/how-do-i-select-the-country-where-i-want-to-sell-my-devices\/\">How do I select the country where I want to sell my devices?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-9-post-4141\" class=\"fusion-post-grid post-4141 post type-post status-publish format-standard hentry category-faq-en category-what-is-a-regulatory-strategy\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/18\/do-find-the-information-need-to-sell-my-devices\/\">How do I find the information I need to sell my devices?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-10\" style=\"--awb-margin-top:35px;\"><h2 class=\"fusion-responsive-typography-calculated\" style=\"--fontsize: 24; line-height: 1.2; --minfontsize: 24;\" data-fontsize=\"24\" data-lineheight=\"28.8px\">What are GMP requirements<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-10 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-10 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-10 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-10-post-6805\" class=\"fusion-post-grid post-6805 post type-post status-publish format-standard hentry category-faq-en category-what-are-the-gmp-requirements-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2019\/08\/23\/what-about-the-mdsap\/\">What is MDSAP?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-4284\" class=\"fusion-post-grid post-4284 post type-post status-publish format-standard hentry category-faq-en category-what-are-the-gmp-requirements-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/cgmp-fda-when-can-exclude-the-design-from-my-quality-system-according-to-the-us-cgmp\/\">cGMp FDA: when can I exclude the design from my quality system according to the US cGMP?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-4274\" class=\"fusion-post-grid post-4274 post type-post status-publish format-standard hentry category-faq-en category-what-are-the-gmp-requirements-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/many-reviews-should-expect-during-the-device-design\/\">How many reviews should I expect during the device design ?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-4266\" class=\"fusion-post-grid post-4266 post type-post status-publish format-standard hentry category-faq-en category-what-are-the-gmp-requirements-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/marketing-canada-what-are-the-disclosure-obligations-required-by-directive-sor-98-282\/\">Marketing in Canada: what are the disclosure obligations required by Directive SOR 98-282?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-10-post-4256\" class=\"fusion-post-grid post-4256 post type-post status-publish format-standard hentry category-faq-en category-what-are-the-gmp-requirements-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/gmp-fda-which-production-processes-should-validate\/\">GMP FDA: which production processes should I validate?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-text fusion-text-11\" style=\"--awb-margin-top:35px;\"><p><!-- wp:html --><\/p>\n<h2>How to register Medical Devices in the world<\/h2>\n<\/div><div class=\"fusion-blog-shortcode fusion-blog-shortcode-11 fusion-blog-archive fusion-blog-layout-grid-wrapper fusion-blog-no fusion-blog-no-images\"><style type=\"text\/css\">.fusion-blog-shortcode-11 .fusion-blog-layout-grid .fusion-post-grid{padding:0px;}.fusion-blog-shortcode-11 .fusion-posts-container{margin-left: -0px !important; margin-right:-0px !important;}<\/style><div class=\"fusion-posts-container fusion-posts-container-no fusion-no-meta-info fusion-blog-layout-grid fusion-blog-layout-grid-4 isotope fusion-blog-equal-heights\" data-pages=\"0\" data-grid-col-space=\"0.0\" style=\"margin: -0px -0px 0;min-height:500px;\"><article id=\"blog-11-post-4240\" class=\"fusion-post-grid post-4240 post type-post status-publish format-standard hentry category-faq-en category-how-do-i-register-medical-devices-in-the-world-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/marketing-canada-what-is-the-difference-between-mdal-and-mdel\/\">Marketing in Canada: what is the difference between MDAL and MDEL?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-11-post-4199\" class=\"fusion-post-grid post-4199 post type-post status-publish format-standard hentry category-faq-en category-how-do-i-register-medical-devices-in-the-world-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/18\/marketing-brazil-do-need-to-get-the-inmetro-mark\/\">Marketing in Brazil: do I need to get the INMETRO mark?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-11-post-4195\" class=\"fusion-post-grid post-4195 post type-post status-publish format-standard hentry category-faq-en category-how-do-i-register-medical-devices-in-the-world-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/18\/what-is-the-510\/\">What is the 510(k)?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<article id=\"blog-11-post-4192\" class=\"fusion-post-grid post-4192 post type-post status-publish format-standard hentry category-faq-en category-how-do-i-register-medical-devices-in-the-world-faq-en\">\n<div class=\"fusion-post-wrapper\" style=\"background-color:rgba(255,255,255,0);border:1px solid #dbe2ea;border-bottom-width:3px;\"><div class=\"fusion-post-content-wrapper\" style=\"padding:  ;\"><div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2017\/07\/18\/marketing-china-what-is-the-legal-agent-responsible-for\/\">Marketing in China: what is the Legal Agent responsible for?<\/a><\/h2><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div>\n<\/article>\n<div class=\"fusion-clearfix\"><\/div><\/div><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-2 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\"><div 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