{"id":19837,"date":"2021-12-20T10:11:36","date_gmt":"2021-12-20T09:11:36","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=19837"},"modified":"2021-12-20T10:11:36","modified_gmt":"2021-12-20T09:11:36","slug":"europe-published-the-implementing-regulation-eu-2021-2078-on-eudamed","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2021\/12\/20\/europe-published-the-implementing-regulation-eu-2021-2078-on-eudamed\/","title":{"rendered":"EUROPE: published the Implementing Regulation (EU) 2021\/2078 on EUDAMED"},"content":{"rendered":"\n<p>The <strong>Implementing\nRegulation (EU) 2021\/2078 of November 26<sup>th<\/sup>, 2021<\/strong>, published on\nthe <strong>Official Journal of the European Union,<\/strong> lays down application rules\nfor European Parliament and Council MDR (EU) 2017\/745 Regulation on <strong>EUDAMED<\/strong>,\nEuropean database on medical devices.<\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2021\/12\/commissione-europea-regolamento-esecuzione-2021-2078-eudamed-1024x536.jpg\" alt=\"Europe published the Implementing Regulation (EU) 2021\/2078 on EUDAMED\" class=\"wp-image-19776\"\/><figcaption>Published the Implementing Regulation (EU) 2021\/2078 on EUDAMED<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>An Implementing Regulation to deal with EUDAMED<\/strong><\/h2>\n\n\n\n<p>The European\nCommission adopted the <strong>Implementing Regulation (EU) 2021\/2078 <\/strong>considering\nthat MDR (EU) 2017\/745 Regulation requires the European Commission to establish\nthe detailed modalities for the establishment and the management of the\nEuropean database on medical devices, and that, as foreseen by MDR and IVDR\nRegulations, the Commission, the relevant Authorities, the Notified Bodies, the\nManufacturers, the Representatives, the Importers, and other involved parties\nmust have access to EUDAMED and use it for fulfilling their own obligations and\ncarrying out their own tasks under these Regulations.<\/p>\n\n\n\n<p>In particular, the\n<strong>Regulation governs <\/strong>some aspects, such as:<\/p>\n\n\n\n<ul class=\"wp-block-list\"><li><strong>How to access<\/strong> EUDAMED;<\/li><li>EUDAMED accessibility in order\nto allow <strong>data exchanges<\/strong> between European and national databases<\/li><li><strong>Technical support from\nEuropean Commission<\/strong> to promptly help EUDAMED users;<\/li><li>Measures which European\nCommission has to adopt in case of a <strong>EUDAMED malfunctioning.<\/strong><\/li><\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>EUDAMED: Medical Devices databases partially online<\/strong><\/h2>\n\n\n\n<p>As you may know,\nat the moment, EUDAMED is not fully up and running. Currently, just the first\nthree of its six modules have been published:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li>Actor Registration Module.<\/li><li>UDI\/Devices registration.<\/li><li>Notified Bodies and\nCertificates.<\/li><\/ol>\n\n\n\n<p>In the past\nmonths, the European Commission has published <strong>handbooks<\/strong> on how to use these\nmodules.<\/p>\n\n\n\n<p>For additional information, read our articles: <a href=\"https:\/\/www.thema-med.com\/en\/mdcg-ready-eudamed-actor-registration-module\/\">\u201cMDCG: ready EUDAMED Actor registration module\u201d<\/a> e <a href=\"https:\/\/www.thema-med.com\/en\/online-eudamed-modules-udi-devices-notified-bodies-certificates\/\">\u201cEUDAMED: \u201cUDI\/ devices registration\u201d and \u201cNotified Bodies and certificates\u201d modules have been published\u201d<\/a>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you need a valid support for EUDAMED?<\/strong><\/h2>\n\n\n\n<p>Despite <strong>EUDAMED\ndelay<\/strong>, if you are an Economic Operator, it is appropriate <strong>to act as of\nnow<\/strong>, because the procedures to be followed require a lot of time.<\/p>\n\n\n\n<p><strong>You can rely\non Thema<\/strong> for adjustments to MDR (UE) 2017\/745 and\nIVDR (UE) 2017\/746 Regulations, <strong>EUDAMED registration<\/strong> included, up to the\nnotification to the Ministry of Health of the reference Member State, which\nwill issue the SRN code (Single Registration Number), if authorised.<\/p>\n\n\n\n<p>Visit the website <a href=\"https:\/\/www.thema-med.com\/en\/services\/italian-and-european-ministerial-registrations\/\"><strong>Italian and European ministerial registrations<\/strong><\/a> and find out <strong>what we can do for you<\/strong>, or <strong><a href=\"mailto:sales@thema-med.com\">contact us<\/a><\/strong>!<\/p>\n\n\n\n<p><em>Sources:<\/em><\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/PDF\/?uri=CELEX:32021R2078&amp;qid=1639735804093&amp;from=en\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">Commission Implementing Regulation (EU) 2021\/2078, Official Journal of the European Union, 26 november 2021 <\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_user_guide_actor_module_en.pdf\" target=\"_blank\">\u201cGuide to using EUDAMED\u201d, European Commission, september 2021<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_eudamed_udi-devices-user-guide_en.pdf\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\">\u201cUDI\/Devices User Guide for Economic Operators\u201d, European Commission, october 2021<\/a><\/p>\n\n\n\n<p><a rel=\"noreferrer noopener\" aria-label=\" (si apre in una nuova scheda)\" href=\"https:\/\/ec.europa.eu\/health\/sites\/default\/files\/md_eudamed\/docs\/md_eudamed-nb-user-guide_en.pdf\" target=\"_blank\">\u201cNotified Bodies User Guide\u201d, European Commission, september 2021<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Implementing Regulation (EU) 2021\/2078 of November 26th, 2021, published on the Official Journal of the European Union, lays down application  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[],"class_list":["post-19837","post","type-post","status-publish","format-standard","hentry","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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