{"id":15638,"date":"2020-09-08T08:46:46","date_gmt":"2020-09-08T06:46:46","guid":{"rendered":"https:\/\/www.thema-med.com\/?p=15638"},"modified":"2020-09-08T08:46:46","modified_gmt":"2020-09-08T06:46:46","slug":"regulation-ivdr-eu-2017-746-main-changes","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2020\/09\/08\/regulation-ivdr-eu-2017-746-main-changes\/","title":{"rendered":"In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746: main changes"},"content":{"rendered":"\n<p>The <strong>Regulation on In Vitro Diagnostic Medical Devices IVDR (EU) 2017\/746<\/strong>, published on May 5, 2017 and entered into force on May 26, 2017, provides rules and requirements for placing on the market, making available and putting into service&nbsp;<strong>in vitro diagnostic medical devices<\/strong>&nbsp;from&nbsp;<strong>May 26, 2022<\/strong>. <\/p>\n\n\n\n<p>IVDR replaces the current Directive 98\/79\/EC.<\/p>\n\n\n\n<p>This regulation sets out many new and innovative requirements: the prescribed actions shall be organized in time in order not to be found unprepared at the time of full application of the IVDR (EU) 2017\/746. <\/p>\n\n\n\n<figure class=\"wp-block-image\"><img decoding=\"async\" src=\"https:\/\/www.thema-med.com\/wp-content\/uploads\/2020\/09\/regolamento-ivdr-ue-2017-746-1-1024x535.png\" alt=\"In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746 main changes\" class=\"wp-image-15606\"\/><figcaption>In Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746: main changes<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>IVDR (EU) 2017\/746: what do in Vitro Diagnostic Medical Devices Manufacturers have to do?<\/strong><\/h2>\n\n\n\n<p>Below, the <strong>6 most challenging aspects<\/strong> in the implementation of the Regulation that must be considered for a correct implementation of the same:<\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong><span class=\"elencopunti\">Applicability Expansion.&nbsp;<\/span><\/strong><br>On the in Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746, <strong>the scope of the IVDs is extended<\/strong> to include diagnostic services, genetic tests and other tests providing information on the predisposition of patients to develop a disease or on sensitivity to a medical therapy.<br><br><\/li><li><strong><span class=\"elencopunti\">Reclassification<\/span> of devices according to the risk and intervention of Notified Bodies.&nbsp;<\/strong><br>The in Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746 includes&nbsp;<strong>new reclassification rules&nbsp;<\/strong>for the IVDs according to their degree of risk (Class A for low-risk devices, Class D for high-risk devices). About the 90% of the IVDs, for which \u201cself-certification\u201d is currently envisaged, shall be <strong>reclassified<\/strong> according to the IVDR and they will require the certification of a Notified Body, in a more stringent and rigorous control context.<br><br><\/li><li><strong><span class=\"elencopunti\">More Documentation.<\/span><\/strong><br>The in Vitro Diagnostic Medical Devices Regulation IVDR (EU) 2017\/746 requires&nbsp;<strong>more formalization of content and more detailed information<\/strong>&nbsp;for technical documentation and&nbsp;<strong>to demonstrate the conformity of a device<\/strong>.<br><br><\/li><li><strong><span class=\"elencopunti\">Responsible Person.<\/span><\/strong><br>Manufacturers shall appoint at least one Responsible Person for Regulatory Compliance, having a well-defined role, tasks and minimum requirements.<br><br><\/li><li><strong><span class=\"elencopunti\">Unique Device Identification (UDI)<\/span><\/strong>.<br>Unique code <strong>allows to improve devices traceability<\/strong> and to make faster and more efficient a possible recall on products for which safety risks have been identified.<br><br><\/li><li><strong><span class=\"elencopunti\">Performance Evaluation (Vdp)<\/span><\/strong>.<br>In order to continuously document the assessment of performance, Manufacturer shall create and update a Vdp plan specifying the characteristics and performance of the device, as well as processes and criteria applied to generate the necessary clinical evidence. The&nbsp;<strong>Performance Evaluation Report contains supported and sufficient data&nbsp;<\/strong>to demonstrate scientific validity, analytical performance and clinical performance of the device. Moreover, it is necessary to implement the&nbsp;<strong>Post-Market Performance Follow-up (PMPF)<\/strong>, a continuous process of Performance Evaluation to be able to continuously update them throughout the entire product life cycle. <\/li><\/ol>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Do you want to get ready for May 26, 2022?<\/strong><\/h2>\n\n\n\n<p class=\"has-medium-font-size\"><strong>Trust our Thema consultants!<\/strong><\/p>\n\n\n\n<p>Thanks to effective field experience, our team of experts can support you throughout the IVDR (EU) 2017\/746 preparation phase to initiate, from the outset, the necessary actions so that you will be ready before May  26, 2022, IVDR application date.<\/p>\n\n\n\n<p>Do not wait any longer, there is so much to do. Below, you can see <strong>5 key steps<\/strong> to implement a timely and effective regulatory strategy approach to this regulation: <\/p>\n\n\n\n<ol class=\"wp-block-list\"><li><strong>Carring out an accurate Gap-Analysis.<\/strong><\/li><li><strong>Verifing the new classification rules.<\/strong><\/li><li><strong>Checking your Technical Documentation and Quality Management System.<\/strong><\/li><li><strong>Reviewing your product labelling.<\/strong><\/li><li><strong>Preparing your Post-market Plan. <\/strong><\/li><\/ol>\n\n\n\n<p><strong><a href=\"https:\/\/www.thema-med.com\/en\/faq\/#ivdr\">See our FAQ section!<\/a> <\/strong> <strong>You will find the answers to some frequently asked questions about the IVDR (EU) 2017\/746. <\/strong><\/p>\n\n\n\n<div class=\"wp-block-button\"><a class=\"wp-block-button__link has-text-color has-background\" href=\"mailto:sales@thema-group.it\" style=\"background-color:#0099a8;color:#ffffff\"><strong>Contact us for consultancy!<\/strong><\/a><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Are you a Manufacturer of in vitro Diagnostic Medical Devices?<\/strong><\/h2>\n\n\n\n<p><strong>Fill out the form!<\/strong><\/p>\n\n\n\n<p>You will receive our White Paper directly on your inbox: a <strong>valuable help<\/strong> to understand the necessary actions to be taken to adapt to the IVDR and to be able <strong>to market your IVDR devices throughout Europe<\/strong>.<\/p>\n\n\n\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f17991-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"17991\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/posts\/15638#wpcf7-f17991-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"17991\" \/><input 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value=\"China\">China<\/option><option value=\"Colombia\">Colombia<\/option><option value=\"Comoros\">Comoros<\/option><option value=\"Costa Rica\">Costa Rica<\/option><option value=\"C\u00f4te d\u2019Ivoire\">C\u00f4te d\u2019Ivoire<\/option><option value=\"Croatia\">Croatia<\/option><option value=\"Cuba\">Cuba<\/option><option value=\"Cyprus\">Cyprus<\/option><option value=\"Czech Republic\">Czech Republic<\/option><option value=\"Denmark\">Denmark<\/option><option value=\"Dominica\">Dominica<\/option><option value=\"Dominican Republic\">Dominican Republic<\/option><option value=\"Ecuador\">Ecuador<\/option><option value=\"Egypt\">Egypt<\/option><option value=\"El Salvador\">El Salvador<\/option><option value=\"Equatorial Guinea\">Equatorial Guinea<\/option><option value=\"Eritrea\">Eritrea<\/option><option value=\"Estonia\">Estonia<\/option><option value=\"Eswatini\">Eswatini<\/option><option value=\"Ethiopia\">Ethiopia<\/option><option value=\"Finland\">Finland<\/option><option 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value=\"Malta\">Malta<\/option><option value=\"Mauritania\">Mauritania<\/option><option value=\"Mauritius\">Mauritius<\/option><option value=\"Mexico\">Mexico<\/option><option value=\"Moldova\">Moldova<\/option><option value=\"Monaco\">Monaco<\/option><option value=\"Mongolia\">Mongolia<\/option><option value=\"Montenegro\">Montenegro<\/option><option value=\"Morocco\">Morocco<\/option><option value=\"Mozambique\">Mozambique<\/option><option value=\"Myanmar (Burma)\">Myanmar (Burma)<\/option><option value=\"Namibia\">Namibia<\/option><option value=\"Nauru\">Nauru<\/option><option value=\"Nepal\">Nepal<\/option><option value=\"Netherlands\">Netherlands<\/option><option value=\"New Zealand\">New Zealand<\/option><option value=\"Nicaragua\">Nicaragua<\/option><option value=\"Niger\">Niger<\/option><option value=\"Nigeria\">Nigeria<\/option><option value=\"North Macedonia\">North Macedonia<\/option><option value=\"Norway\">Norway<\/option><option value=\"Oman\">Oman<\/option><option 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Emirates\">United Arab Emirates<\/option><option value=\"United Kingdom\">United Kingdom<\/option><option value=\"United States\">United States<\/option><option value=\"Uruguay\">Uruguay<\/option><option value=\"Uzbekistan\">Uzbekistan<\/option><option value=\"Vatican City\">Vatican City<\/option><option value=\"Venezuela\">Venezuela<\/option><option value=\"Vietnam\">Vietnam<\/option><option value=\"Yemen\">Yemen<\/option><option value=\"Zambia\">Zambia<\/option><option value=\"Zimbabwe\">Zimbabwe<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Role\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"ruolo\"><select class=\"wpcf7-form-control wpcf7-select wpcf7-validates-as-required\" aria-required=\"true\" aria-invalid=\"false\" name=\"ruolo\"><option value=\"\">&#8212;Please choose an option&#8212;<\/option><option value=\"Purchasing\">Purchasing<\/option><option value=\"Sales\">Sales<\/option><option value=\"Marketing\">Marketing<\/option><option value=\"Administration\">Administration<\/option><option value=\"QA\/RA\">QA\/RA<\/option><option value=\"Management\">Management<\/option><option value=\"R &amp; D\">R &amp; D<\/option><option value=\"Other\">Other<\/option><\/select><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>Email\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><span class=\"wpcf7-form-control-wrap\" data-name=\"your-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-email wpcf7-validates-as-required wpcf7-text wpcf7-validates-as-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"email\" name=\"your-email\" \/><\/span>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td colspan=\"2\">\n\t\t\t<table>\n\t\t\t\t<tr>\n\t\t\t\t\t<td>\n\t\t\t\t\t\t<p><span class=\"wpcf7-form-control-wrap\" 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Lgs. 101\/2018, I agree to receive the CONTENT referred to in question and receive the periodic NEWSLETTER INFORMATION Thema S.r.l<br \/>\n<a href=\"https:\/\/www.thema-med.com\/en\/newsletter-information\/ \">Information concerning the processing of personal data<\/a>\n\t\t\t\t\t\t<\/p>\n\t\t\t\t\t<\/td>\n\t\t\t\t<\/tr>\n\t\t\t<\/table>\n\t\t<\/td>\n\t<\/tr>\n\t<tr>\n\t\t<td>\n\t\t\t<p>&nbsp;\n\t\t\t<\/p>\n\t\t<\/td>\n\t\t<td>\n\t\t\t<p><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Download the Whitepaper\" \/>\n\t\t\t<\/p>\n\t\t<\/td>\n\t<\/tr>\n<\/table><div class=\"fusion-alert alert custom alert-custom fusion-alert-center wpcf7-response-output fusion-alert-capitalize awb-alert-native-link-color\" style=\"--awb-border-top-left-radius:0px;--awb-border-top-right-radius:0px;--awb-border-bottom-left-radius:0px;--awb-border-bottom-right-radius:0px;\" role=\"alert\"><div class=\"fusion-alert-content-wrapper\"><span class=\"fusion-alert-content\"><\/span><\/div><\/div>\n<\/form>\n<\/div>\n\n","protected":false},"excerpt":{"rendered":"<p>The Regulation on In Vitro Diagnostic Medical Devices IVDR (EU) 2017\/746, published on May 5, 2017 and entered into force on  [&#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":[679],"tags":[],"class_list":["post-15638","post","type-post","status-publish","format-standard","hentry","category-blog-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>The Regulation IVDR (EU) 2017\/746: main changes<\/title>\n<meta name=\"description\" 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