{"id":7009,"date":"2023-06-05T14:55:42","date_gmt":"2023-06-05T12:55:42","guid":{"rendered":"https:\/\/www.entecerma.it\/webinar-ecm-extension-of-the-mdr-transitional-period\/"},"modified":"2023-06-05T14:59:57","modified_gmt":"2023-06-05T12:59:57","slug":"webinar-ecm-extension-of-the-mdr-transitional-period","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/webinar-ecm-extension-of-the-mdr-transitional-period\/","title":{"rendered":"WEBINAR ECM: extension of the MDR transitional period"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong><em>On 14 June 2023, ECM Medical Devices Division organizes an in-depth webinar on how to deal with the extension of the MDR transitional provisions, introduced by Regulation (EU) 2023\/607.<\/em><\/strong><\/h2>\n\n<p>The <strong>extension of Regulation (EU) 2017\/745 transitional provisions<\/strong>, stated in the <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=uriserv:OJ.L_.2023.080.01.0024.01.ENG\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2023\/607<\/a> of 15 March 2023, has led to important implications on both manufacturers and notified bodies. The extension of the validity of MDD certificates is actually <strong>bound to certain conditions<\/strong>, including that by 26\/05\/2024 the manufacturer has submitted the application for certification to a notified body and by 26\/09\/2024 a written agreement between the parties has been concluded.<\/p>\n\n<p>ECM, as <strong>Notified Body 1282<\/strong> for MDR, periodically attends international meetings with institutions, stakeholders and certification bodies to discuss regulatory updates and identify a shared approach to regulatory changes. At the latest events in which ECM participated \u2013 the Team-NB General Assembly, the 68th NBCG-Med meeting, and the RA DAY of Confindustria DM \u2013 the parties involved emphasized the importance for manufacturers to approach a Notified Body as soon as possible to start the MDR certification process.<\/p>\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-text-color\" style=\"color:#085f9b\"><strong>THE ECM WEBINAR<\/strong><\/h2>\n\n<p>In order to outline these important updates, on <strong>Wednesday, June 14, 2023 &#8211; 3:30 p.m. to 4:30 p.m<\/strong>., ECM will schedule the free live <strong>webinar<\/strong> <strong><em>&#8220;How to deal with the extension of the MDR transitional provisions&#8221;<\/em><\/strong>.<\/p>\n\n<p>The ECM webinar will focus on regulatory news approached from the <strong>perspective of the notified body<\/strong>, including:<\/p>\n\n<ul class=\"wp-block-list\">\n<li>requirements to benefit from extended validity of MDD certificates<\/li>\n\n\n\n<li>elimination of the &#8220;sell-off&#8221; date<\/li>\n\n\n\n<li>surveillance by notified bodies.<\/li>\n<\/ul>\n\n<p>The speaker for the webinar is our Sales Manager of the Medical Devices Division <em>Eng. Diego Stevanella<\/em>.<\/p>\n\n<p>At the end of the event a Q&amp;A session is also scheduled in order to answer any questions participants may have.<\/p>\n\n<p><strong>For more information<\/strong>, please feel free to contact us at: Eng. Diego Stevanella \u2013 Sales Manager ECM <a href=\"mailto:Diego.s@entecerma.it\" target=\"_blank\" rel=\"noopener\">diego.s@entecerma.it<\/a> | (+39) 393 2471040<\/p>\n\n<p>Download the event flyer &gt;&gt; <\/p>\n\n<div style=\"height:14px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<div class=\"wp-block-buttons is-horizontal is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-499968f5 wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-white-color has-text-color has-background wp-element-button\" href=\"https:\/\/www.entecerma.it\/wp-content\/uploads\/2023\/05\/Registration-form_webinar-14.06.2023.docx\" style=\"background-color:#085f9b\" target=\"_blank\" rel=\"noreferrer noopener\">SIGN UP NOW<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>On 14 June 2023, ECM Medical Devices Division organizes an in-depth webinar on how to&#8230;<\/p>\n","protected":false},"author":2,"featured_media":7005,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[13,2],"tags":[],"class_list":["post-7009","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events","category-news"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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