{"id":4256,"date":"2021-05-26T10:33:59","date_gmt":"2021-05-26T08:33:59","guid":{"rendered":"https:\/\/www.entecerma.it\/mdr-is-now-its-time-to-start-working-towards-the-mdr-certification\/"},"modified":"2021-05-26T10:42:29","modified_gmt":"2021-05-26T08:42:29","slug":"mdr-is-now-its-time-to-start-working-towards-the-mdr-certification","status":"publish","type":"post","link":"https:\/\/www.entecerma.it\/en\/mdr-is-now-its-time-to-start-working-towards-the-mdr-certification\/","title":{"rendered":"MDR is NOW! It\u2019s time to start working towards the MDR certification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" style=\"font-size:27px\"><strong><em>On the 26th May 2021, the transition period for manufacturers to place new medical devices on the market certified according to the Directive 93\/42\/EEC (MDD) ends.\u00a0 <\/em><\/strong><\/h2>\n\n<p>As of today, to place medical devices on the European market, it will be necessary to CE mark them according to the new MDR 2017\/745. The certification process under the new MDR 2017\/745 sets <strong>stricter requirements<\/strong> for manufacturers wishing to market their devices within the EU market.<\/p>\n\n<p>The <strong>MDR certification process<\/strong>, likewise the MDD process, involves the following steps:<\/p>\n\n<ol class=\"wp-block-list\" type=\"1\"><li>Document Review (Technical File, Clinical Evaluation Report, Quality System Manual),<\/li><li>On-site Audit, after the closure of non-conformities of phase 1,<\/li><li>Final Review and Issuance of the EC certification, after the closure of non-conformities of phase 2.<\/li><\/ol>\n\n<p>During phases 1 and 2, important delays can occur due to any non-conformities found. In order to avoid such concerns, Companies should proceed with a\u00a0<strong><span class=\"has-inline-color\" style=\"color: #085f9b;\">pre-assessment of the document<\/span><\/strong>, so to make sure to start on the right foot the CE marking process of the product according to Regulation (EU) 2017\/745.<\/p>\n\n<p>The aim of the <strong>gap-analysis<\/strong> is to outline the gaps that the manufacturer will need to fill in order to meet the requirements of the MDR.<\/p>\n\n<p>Another key factor for manufacturers who want to make sure to be prepared for the certification process is <strong><span class=\"has-inline-color\" style=\"color: #085f9b;\">training<\/span><\/strong>.<\/p>\n\n<p>In order to move smoothly through the complexity of the MDR regulatory requirements, it is necessary to <strong>strengthen<\/strong> your resources. Only through an <strong>in-depth knowledge<\/strong> of the subject it will it be possible to face the certification process with awareness and confidence.<\/p>\n\n<p><a href=\"https:\/\/www.entecerma.it\/en\/activities\/training\/medical-devices\/\" target=\"_blank\" rel=\"noreferrer noopener\"><strong>ECM Divisione Academy<\/strong><\/a> offers a <strong>wide range of training courses<\/strong> to allow companies and professionals to improve their skills, in order to operate with greater efficiency and professionalism.<\/p>\n\n<div style=\"height:9px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\"><p><strong>To find out more about our services<\/strong> dedicated to the new Regulation 2017\/745 (MDR), contact our Sales Manager Antonio Balassone at <a href=\"mailto:antonio@entecerma.it\">antonio@entecerma.it<\/a> | cell. (+39) 393 2471040<\/p><\/blockquote>\n","protected":false},"excerpt":{"rendered":"<p>On the 26th May 2021, the transition period for manufacturers to place new medical devices&#8230;<\/p>\n","protected":false},"author":2,"featured_media":4252,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[2],"tags":[407,282,128,569,404,503],"class_list":["post-4256","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-certificazione-ce-en","tag-dispositivi-medici-en","tag-mdr-2017-745-en","tag-medical-device-certification-en","tag-medical-device-regulation-en","tag-regolamento-dispositivi-medici-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>MDR is NOW! 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