{"id":21807,"date":"2022-07-25T10:59:11","date_gmt":"2022-07-25T08:59:11","guid":{"rendered":"http:\/\/www.thema-med.eu\/?page_id=21807"},"modified":"2023-01-24T15:00:29","modified_gmt":"2023-01-24T14:00:29","slug":"news","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/news\/","title":{"rendered":"News"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-background-position:left top;--awb-border-sizes-top:0px;--awb-border-sizes-bottom:0px;--awb-border-sizes-left:0px;--awb-border-sizes-right:0px;--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-padding-top:0px;--awb-padding-bottom:0px;--awb-margin-bottom:20px;--awb-margin-bottom-medium:60px;--awb-margin-bottom-small:40px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-justify-content-center fusion-flex-content-wrap\" style=\"max-width:1144px;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:15px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:15px;--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-blog-shortcode fusion-blog-shortcode-1 fusion-blog-archive fusion-blog-layout-medium fusion-blog-infinite\"><div class=\"fusion-posts-container fusion-posts-container-infinite\" data-pages=\"20\"><article id=\"blog-1-post-35838\" class=\"fusion-post-medium post-35838 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en tag-iso-190112026-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/30\/ppwr-what-changes-and-what-to-prepare-by-12-august-2026\/\" aria-label=\"PPWR: What changes and what to prepare by 12 August 2026\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-5-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-5-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-5-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/30\/ppwr-what-changes-and-what-to-prepare-by-12-august-2026\/\">PPWR: What changes and what to prepare by 12 August 2026<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Regulation (EU) 2025\/40 on packaging and packaging waste (PPWR)\u00a0repeals the Packaging Directive 94\/62\/EC and introduces\u00a0harmonised requirements on sustainability, labelling, re-use, [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-07-31T09:21:28+02:00<\/span><span>30\/07\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35832\" class=\"fusion-post-medium post-35832 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en tag-iso-190112026-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/29\/mdr-and-ivdr-the-commission-updates-the-lists-of-harmonised-standards\/\" aria-label=\"MDR and IVDR: the Commission updates the lists of Harmonised Standards\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-4-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-4-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-4-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/29\/mdr-and-ivdr-the-commission-updates-the-lists-of-harmonised-standards\/\">MDR and IVDR: the Commission updates the lists of Harmonised Standards<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On 17 June 2026, the European Commission published two Implementing Decisions in the Official Journal of the European Union, updating [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-07-29T12:50:28+02:00<\/span><span>29\/07\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35804\" class=\"fusion-post-medium post-35804 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en tag-iso-190112026-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/20\/new-recops-platform-in-spain-the-medical-device-register-integrated-with-eudamed-is-now-operational\/\" aria-label=\"New RECOPS platform in Spain: the medical device register integrated with EUDAMED is now operational\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-3-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-3-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-3-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/20\/new-recops-platform-in-spain-the-medical-device-register-integrated-with-eudamed-is-now-operational\/\">New RECOPS platform in Spain: the medical device register integrated with EUDAMED is now operational<\/a><\/h2><div class=\"fusion-post-content-container\"><p>As announced in the AEMPS Information Note of May 2026, the new RECOPS platform (Registro de Comercializaci\u00f3n de Productos Sanitarios) [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-07-20T16:26:01+02:00<\/span><span>20\/07\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35780\" class=\"fusion-post-medium post-35780 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en tag-iso-190112026-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/13\/switzerland-udi-registration-in-swissdamed-and-clarifications-for-legacy-devices\/\" aria-label=\"Switzerland: UDI registration in swissdamed and clarifications for Legacy Devices\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-2-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-2-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/07\/Immagini-tech-2026-2-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/07\/13\/switzerland-udi-registration-in-swissdamed-and-clarifications-for-legacy-devices\/\">Switzerland: UDI registration in swissdamed and clarifications for Legacy Devices<\/a><\/h2><div class=\"fusion-post-content-container\"><p>As of July 1, 2026, the registration of UDI (Unique Device Identification) data for medical devices and procedure packs in [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-07-13T16:11:28+02:00<\/span><span>13\/07\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35754\" class=\"fusion-post-medium post-35754 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en tag-iso-190112026-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/29\/medical-devices-in-china-nmpa-regulates-the-management-of-classification-changes\/\" aria-label=\"Medical Devices in China: NMPA regulates the management of classification changes\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/close-up-doctor-using-digital-tablet-with-touch-screen-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/close-up-doctor-using-digital-tablet-with-touch-screen-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/close-up-doctor-using-digital-tablet-with-touch-screen-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/29\/medical-devices-in-china-nmpa-regulates-the-management-of-classification-changes\/\">Medical Devices in China: NMPA regulates the management of classification changes<\/a><\/h2><div class=\"fusion-post-content-container\"><p>In China, the classification of medical devices is subject to continuous updates across Class I, II, and III. To regulate and standardize the regulatory consequences of these changes and guide enforcement by local authorities, the National Medical Products Administration (NMPA) published Announcement No. 52\/2026, effective June 1, 2026<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-06-29T14:42:20+02:00<\/span><span>29\/06\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35744\" class=\"fusion-post-medium post-35744 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en tag-digital-evidence-security tag-iso-190112026-en tag-iso-internal-audits tag-management-system-audits tag-remote-auditing\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/22\/iso-19011-2026-management-system-audit-changes\/\" aria-label=\"ISO 19011:2026, What changes for Management System Audits\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/BANNER-NEWSLETTER-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/BANNER-NEWSLETTER-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/BANNER-NEWSLETTER-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/22\/iso-19011-2026-management-system-audit-changes\/\">ISO 19011:2026, What changes for Management System Audits<\/a><\/h2><div class=\"fusion-post-content-container\"><p>At the end of May 2026, the fourth edition of EN ISO 19011 was published, redefining the guidelines for conducting management system audits. Fully replacing the 2018 edition, it formalizes an ongoing operational evolution: remote auditing. <\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-06-29T14:45:50+02:00<\/span><span>22\/06\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35730\" class=\"fusion-post-medium post-35730 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/12\/fda-partially-recognizes-iso-10993-12025-what-changes-for-biocompatibility\/\" aria-label=\"FDA partially recognizes ISO 10993-1:2025: what changes for Biocompatibility\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/immagini-tech-10-1-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/immagini-tech-10-1-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/06\/immagini-tech-10-1-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/06\/12\/fda-partially-recognizes-iso-10993-12025-what-changes-for-biocompatibility\/\">FDA partially recognizes ISO 10993-1:2025: what changes for Biocompatibility<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On May 25, 2026, the US FDA updated its database of recognized consensus standards (Recognition No 2-313), partially adopting the [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-06-12T11:10:09+02:00<\/span><span>12\/06\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35663\" class=\"fusion-post-medium post-35663 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/28\/injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution\/\" aria-label=\"Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/closeup-portrait-young-woman-doing-botox-procedures-by-professional-injection-making-lips-modern-devices-technology-medicine-cosmetology-therapy-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/closeup-portrait-young-woman-doing-botox-procedures-by-professional-injection-making-lips-modern-devices-technology-medicine-cosmetology-therapy-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/closeup-portrait-young-woman-doing-botox-procedures-by-professional-injection-making-lips-modern-devices-technology-medicine-cosmetology-therapy-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/28\/injectable-fillers-clarifications-from-the-italian-ministry-of-health-on-intended-users-and-distribution\/\">Injectable Fillers: Clarifications from the Italian Ministry of Health on Intended Users and Distribution<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On May 11, 2026, the Italian Ministry of Health published a Circular clarifying the distribution and sales modalities of injectable [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-05-28T11:41:22+02:00<\/span><span>28\/05\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35646\" class=\"fusion-post-medium post-35646 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/22\/biocompatibility-and-biological-safety-of-medical-devices-whats-new-in-iso-standards-2025-2026\/\" aria-label=\"Biocompatibility and biological safety of medical devices: what\u2019s new in ISO Standards 2025 &#8211; 2026\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/immagini-tech-4-1-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/immagini-tech-4-1-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/immagini-tech-4-1-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/22\/biocompatibility-and-biological-safety-of-medical-devices-whats-new-in-iso-standards-2025-2026\/\">Biocompatibility and biological safety of medical devices: what\u2019s new in ISO Standards 2025 &#8211; 2026<\/a><\/h2><div class=\"fusion-post-content-container\"><p> In recent months, the regulatory framework governing the biological safety of Medical Devices has undergone a significant evolution. With [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-05-25T09:29:57+02:00<\/span><span>22\/05\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35621\" class=\"fusion-post-medium post-35621 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/15\/regulation-eu-2026-977-new-rules-for-notified-bodies-on-timelines-costs-and-procedures\/\" aria-label=\"Regulation (EU) 2026\/977: new rules for Notified Bodies on timelines, costs and procedures\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/img2-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/img2-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/05\/img2-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/05\/15\/regulation-eu-2026-977-new-rules-for-notified-bodies-on-timelines-costs-and-procedures\/\">Regulation (EU) 2026\/977: new rules for Notified Bodies on timelines, costs and procedures<\/a><\/h2><div class=\"fusion-post-content-container\"><p> On 5 May 2026, Commission Implementing Regulation (EU) 2026\/977 was published, introducing a harmonised framework of quality and procedural [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-05-15T15:45:24+02:00<\/span><span>15\/05\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35580\" class=\"fusion-post-medium post-35580 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/28\/mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification\/\" aria-label=\"MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/tech-3-2-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/tech-3-2-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/tech-3-2-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/28\/mdcg-2021-24-rev-1-interpretative-updates-on-medical-device-classification\/\">MDCG 2021-24 Rev.1: Interpretative Updates on Medical Device Classification<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI On April 20, 2026, Revision 1 of the MDCG 2021-24 guidance was published. This update introduces significant [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-04-29T09:20:47+02:00<\/span><span>28\/04\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35564\" class=\"fusion-post-medium post-35564 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/21\/what-to-do-in-case-of-interruption-or-discontinuation-of-medical-device-supplythe-commission-clarifies-with-a-decision-tree-and-updated-faqs\/\" aria-label=\"What to do in case of interruption or discontinuation of medical device supply?The Commission clarifies with a Decision Tree and updated FAQs\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-30-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-30-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-30-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/21\/what-to-do-in-case-of-interruption-or-discontinuation-of-medical-device-supplythe-commission-clarifies-with-a-decision-tree-and-updated-faqs\/\">What to do in case of interruption or discontinuation of medical device supply?The Commission clarifies with a Decision Tree and updated FAQs<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI. On 1 April 2026, the European Commission published the Article 10a Decision Tree and Revision 2 of [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-04-22T09:41:40+02:00<\/span><span>21\/04\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35511\" class=\"fusion-post-medium post-35511 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/10\/regole-per-letichettatura-dei-dispositivi-medici-in-malesia-cosa-cambia-2\/\" aria-label=\"Health Canada: New Operational Guidance on Terms and Conditions (T&#038;Cs) for Class II\u2013IV Medical Devices\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-15-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-15-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/04\/copertina-video-esmerise-15-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/04\/10\/regole-per-letichettatura-dei-dispositivi-medici-in-malesia-cosa-cambia-2\/\">Health Canada: New Operational Guidance on Terms and Conditions (T&#038;Cs) for Class II\u2013IV Medical Devices<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AIOn April 1, 2026, Health Canada published the \u201cGuidance on terms and conditions for class II to IV [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-04-10T14:48:02+02:00<\/span><span>10\/04\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35458\" class=\"fusion-post-medium post-35458 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/27\/two-delegated-eu-regulations-expand-the-mdr-wet-list\/\" aria-label=\"Two Delegated EU Regulations expand the MDR WET List\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-8-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-8-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-8-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/27\/two-delegated-eu-regulations-expand-the-mdr-wet-list\/\">Two Delegated EU Regulations expand the MDR WET List<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI On March 20, 2026, the European Commission adopted two delegated regulations, C (2026) 1809 and C (2026) [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-03-30T15:53:27+02:00<\/span><span>27\/03\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35445\" class=\"fusion-post-medium post-35445 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/23\/medical-device-labelling-rules-in-malaysia-what-is-changing\/\" aria-label=\"Medical Device Labelling Rules in Malaysia: what is changing\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-4-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-4-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/POST-LINKEDIN-SHORT-1344-x-768-px-4-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/23\/medical-device-labelling-rules-in-malaysia-what-is-changing\/\">Medical Device Labelling Rules in Malaysia: what is changing<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AI In February 2026, the Medical Device Authority (MDA) published the 7th edition of the guidance document \"Requirements [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-03-30T11:31:09+02:00<\/span><span>23\/03\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35414\" class=\"fusion-post-medium post-35414 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/12\/australia-udi-guide-v2-0-how-to-properly-prepare-for-deadlines\/\" aria-label=\"Australia UDI Guide V2.0: how to properly prepare for deadlines\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/IMG-WEBINAR-MASTER-SEMINAR-9-320x202.png\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/IMG-WEBINAR-MASTER-SEMINAR-9-320x202.png 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/03\/IMG-WEBINAR-MASTER-SEMINAR-9-700x441.png 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/03\/12\/australia-udi-guide-v2-0-how-to-properly-prepare-for-deadlines\/\">Australia UDI Guide V2.0: how to properly prepare for deadlines<\/a><\/h2><div class=\"fusion-post-content-container\"><p>Translated with AIIn February 2026, the Australian Therapeutic Goods Administration (TGA) published version 2.0 of the official guide: \"Complying with [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-03-30T09:08:52+02:00<\/span><span>12\/03\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35377\" class=\"fusion-post-medium post-35377 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/26\/mdsap-audit-approach-version-010-released-what-changes\/\" aria-label=\"MDSAP: Audit Approach Version 010 Released, what changes\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/business-concept-glass-world-laptop-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/business-concept-glass-world-laptop-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/business-concept-glass-world-laptop-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/26\/mdsap-audit-approach-version-010-released-what-changes\/\">MDSAP: Audit Approach Version 010 Released, what changes<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On February 2, 2026, version 010 of the MDSAP AU P0002 \u2013 Audit Approach manual was released. This update comes [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-26T14:25:19+01:00<\/span><span>26\/02\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<article id=\"blog-1-post-35362\" class=\"fusion-post-medium post-35362 post type-post status-publish format-standard has-post-thumbnail hentry category-news-en\">\n\t<style type=\"text\/css\">\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\t<\/style>\n\n\n\t\t\t<div class=\"fusion-flexslider flexslider fusion-flexslider-loading fusion-post-slideshow\" style=\"\">\n\t\t<ul class=\"slides\">\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<li><div  class=\"fusion-image-wrapper fusion-image-size-fixed\" aria-haspopup=\"true\">\n\t\t\t\t\t\t\t<a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/24\/compliance-program-7382-850-what-to-expect-from-the-new-fda-inspections\/\" aria-label=\"Compliance Program 7382.850: what to expect from the new FDA inspections\">\n\t\t\t\t\t\t\t<img decoding=\"async\" width=\"320\" height=\"202\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/BANNER-NEWSLETTER1-1200x600-1-320x202.jpg\" class=\"attachment-blog-medium size-blog-medium wp-post-image\" alt=\"\" srcset=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/BANNER-NEWSLETTER1-1200x600-1-320x202.jpg 320w, https:\/\/www.thema-med.com\/wp-content\/uploads\/2026\/02\/BANNER-NEWSLETTER1-1200x600-1-700x441.jpg 700w\" sizes=\"(max-width: 320px) 100vw, 320px\" \/>\t\t\t<\/a>\n\t\t\t\t\t\t\t<\/div>\n<\/li>\n\t\t\t\n\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/ul>\n\t<\/div>\n\t<div class=\"fusion-post-content post-content\"><h2 class=\"blog-shortcode-post-title entry-title\"><a href=\"https:\/\/www.thema-med.com\/en\/2026\/02\/24\/compliance-program-7382-850-what-to-expect-from-the-new-fda-inspections\/\">Compliance Program 7382.850: what to expect from the new FDA inspections<\/a><\/h2><div class=\"fusion-post-content-container\"><p>On February 2, 2026, the U.S. Food and Drug Administration issued the Compliance Program Manual 7382.850. The comprehensive document serves [...]<\/p><\/div><\/div><div class=\"fusion-clearfix\"><\/div><div class=\"fusion-meta-info\"><div class=\"fusion-alignleft\"><span class=\"vcard\" style=\"display: none;\"><span class=\"fn\"><a href=\"https:\/\/www.thema-med.com\/en\/author\/ufficiomarketing\/\" title=\"Posts by ufficiomarketing\" rel=\"author\">ufficiomarketing<\/a><\/span><\/span><span class=\"updated\" style=\"display:none;\">2026-02-24T10:16:43+01:00<\/span><span>24\/02\/2026<\/span><span class=\"fusion-inline-sep\">|<\/span><a href=\"https:\/\/www.thema-med.com\/en\/category\/news-en\/\" rel=\"category tag\">News<\/a><span class=\"fusion-inline-sep\">|<\/span><\/div><\/div><\/article>\n<\/div><div class=\"fusion-infinite-scroll-trigger\"><\/div><div class=\"pagination infinite-scroll clearfix\" style=\"display:none;\"><span class=\"current\">1<\/span><a href=\"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/21807\/page\/2\/\" class=\"inactive\">2<\/a><a class=\"pagination-next\" rel=\"next\" href=\"https:\/\/www.thema-med.com\/en\/wp-json\/wp\/v2\/pages\/21807\/page\/2\/\"><span class=\"page-text\">Next<\/span><span class=\"page-next\"><\/span><\/a><\/div><div class=\"fusion-clearfix\"><\/div><\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":114,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"class_list":["post-21807","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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