{"id":8194,"date":"2024-01-12T17:04:45","date_gmt":"2024-01-12T17:04:45","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8194"},"modified":"2024-01-12T17:09:34","modified_gmt":"2024-01-12T17:09:34","slug":"mdr-regs-apply-to-all","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/mdr-regs-apply-to-all\/","title":{"rendered":"25 EU MDR Articles That Apply to Legacy MDD Medical Devices Right NOW"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8194\" class=\"elementor elementor-8194\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/12\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 12, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">25 EU MDR Articles That Apply to Legacy MDD Medical Devices Right NOW\n<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"2560\" height=\"1440\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-scaled.jpeg\" class=\"attachment-full size-full wp-image-5302\" alt=\"paper checklist with a black leaded pencil\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-scaled.jpeg 2560w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-300x169.jpeg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-1024x576.jpeg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-768x432.jpeg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-1536x864.jpeg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2022\/10\/checklist-black-pencil-2048x1152.jpeg 2048w\" sizes=\"(max-width: 2560px) 100vw, 2560px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p><strong>Does this situation sound familiar?<\/strong>\u00a0You\u2019re sitting on an existing valid Medical Devices Directive (MDD) certificate that expires sometime before May 26, 2024. You assume that any obligations to meet the requirements under the Medical Device Regulation (MDR 2017\/745) don\u2019t apply until you get CE certification for that device under the MDR.<\/p><p><em>Are you correct?<\/em>\u00a0Well, not so much, and you\u2019re definitely not alone.<\/p><p>Even the manufacturers that did understand there were some obligations to be followed after the compliance date of May 26, 2021, were certainly confused about what they were supposed to do. In response, the Medical Device Coordination Group (MDCG) released\u00a0<a href=\"https:\/\/health.ec.europa.eu\/latest-updates\/mdcg-2021-25-application-mdr-requirements-legacy-devices-and-devices-placed-market-prior-26-may-2021-2021-10-21_en\" target=\"_blank\" rel=\"noopener noreferrer\">MDCG 2021-25<\/a>\u00a0guidance in late 2021. Before we outline what needs to be done, it\u2019s important to understand the distinction made between old and legacy devices.<\/p><ul><li><ul><li><strong>\u201cOld\u201d devices<\/strong>\u00a0have valid MDD or AIMDD certificates and were\u00a0<u>placed on the European market before<\/u>\u00a0May 26, 2021, the date of application of the MDR.<\/li><li><strong>\u201cLegacy\u201d devices<\/strong>\u00a0have valid certificates but were placed on the European market\u00a0<u>after<\/u>\u00a0May 26, 2021. The definition of legacy devices may be a little confusing because it would seem that any device placed on the European market after May 26, 2021, would be subject to the requirements of the MDR, but for these devices, the MDD CE certificate was obtained before this date and remains valid until expiration or May 26, 2024, whichever comes first.\u00a0This also applies to a lot of Class I reusable surgical devices and some software, which are being \u201cupclassed\u201d and don\u2019t need to comply until 2024.<\/li><\/ul><\/li><\/ul><p>There are numerous articles (sections) within the\u00a0<a href=\"https:\/\/www.orielstat.com\/blog\/table-contents-eu-mdr-2017745\/\" target=\"_blank\" rel=\"noopener noreferrer\">MDR<\/a>, many of which you are likely already following as part of your ongoing compliance with the old MDD.<\/p><h3>\u00a0<\/h3><h3><strong>Postmarket Surveillance (PMS) and Vigilance<\/strong><\/h3><p>Theoretically, this is where the distinction between old and legacy devices becomes important. MDCG 2021-25 specifies that the requirements of Chapter 7 of the MDR (see relevant articles below) only apply to legacy devices. In practice, we are seeing that Notified Bodies are expecting this for all devices, regardless of the distinction between legacy and old. Easy access to all MDR articles listed below can be found\u00a0<a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32017R0745&amp;from=EN#d1e40-1-1\" target=\"_blank\" rel=\"noopener noreferrer\">here<\/a>.<\/p><ul><li><ul><li><strong>Article 83<\/strong>\u00a0\u2013 Post-market surveillance system of the manufacturer<\/li><li><strong>Article 84<\/strong>\u00a0\u2013 Post-market surveillance plan<\/li><li><strong>Article 85<\/strong>\u00a0\u2013 Post-market surveillance report<\/li><li><strong>Article 86<\/strong>\u00a0\u2013 Periodic safety update report<\/li><li><strong>Article 87<\/strong>\u00a0\u2013 Reporting of serious incidents and field safety corrective actions<\/li><li><strong>Article 88<\/strong>\u00a0\u2013 Trend reporting<\/li><li><strong>Article 89<\/strong>\u00a0\u2013 Analysis of serious incidents and field safety corrective actions<\/li><li><strong>Article 90<\/strong>\u00a0\u2013 Analysis of vigilance data<\/li><li><strong>Article 91<\/strong>\u00a0\u2013 Implementing acts<\/li><li><strong>Article 92<\/strong>\u00a0\u2013 Electronic system on vigilance and on post-market surveillance<\/li><li><strong>Article 93<\/strong>\u00a0\u2013 Market surveillance activities (also applies to \u201cold\u201d devices)<\/li><li><strong>Article 94<\/strong>\u00a0\u2013 Evaluation of devices suspected of presenting an unacceptable risk or other non-compliance<\/li><li><strong>Article 95<\/strong>\u00a0\u2013 Procedure for dealing with devices presenting an unacceptable risk to health and safety<\/li><\/ul><\/li><\/ul><h3>\u00a0<\/h3><h3><strong>Economic Operators (EO)<\/strong><\/h3><p>All manufacturers located outside of the European Union already have a European authorized representative (EC REP). However, many manufacturers do not realize that Article 13 of the MDR added a new role called an \u201cimporter.\u201d This terminology is rather confusing because the importer is not responsible for customs clearance or warehousing activities that you might associate with the term. Instead, this \u201ceconomic operator\u201d role focuses on regulatory compliance and has similar responsibilities to your authorized representative.<\/p><ul><li><ul><li><strong>Article 11<\/strong>\u00a0\u2013 Authorised representative (point 3, subpoints C-G; also point 7)<\/li><li><strong>Article 13<\/strong>\u00a0\u2013 General obligations of importers (points 2, 4, 6, 7, 8, and 10)<\/li><li><strong>Article 14<\/strong>\u00a0\u2013 General obligations of distributors<\/li><\/ul><\/li><\/ul><h3>\u00a0<\/h3><h3><strong>EUDAMED<\/strong><\/h3><p>EUDAMED is the new medical device database used by European Competent Authorities and is also available to the public. It is being rolled out in phases and is therefore not yet fully operational. Still, many provisions apply.<\/p><ul><li><ul><li><strong>Article 22<\/strong>\u00a0\u2013 Systems and procedure packs (only applies to system or procedure packs combining legacy and MDR devices)<\/li><li><strong>Article 29<\/strong>\u00a0\u2013 Registration of devices (only certain provisions apply until EUDAMED is fully functional)<\/li><li><strong>Article 31<\/strong>\u00a0\u2013 Registration of manufacturers, authorised representatives and importers (only certain provisions apply until EUDAMED is fully functional)<\/li><li><strong>Article 100<\/strong>\u00a0\u2013 Electronic system on market surveillance (applies to \u201cold\u201d devices as well)<\/li><\/ul><\/li><\/ul><h3>\u00a0<\/h3><h3><strong>Miscellaneous<\/strong><\/h3><ul><li><ul><li><strong>Article 10<\/strong>\u00a0\u2013 General obligations of manufacturers (points 10, 12, 13, 14, and 15)<\/li><li><strong>Article 96<\/strong>\u00a0\u2013 Procedure for evaluating national measures at Union level<\/li><li><strong>Article 97<\/strong>\u00a0\u2013 Other non-compliance<\/li><li><strong>Article 98<\/strong>\u00a0\u2013 Preventive health protection measures<\/li><li><strong>Article 99<\/strong>\u00a0\u2013 Good administrative practice<\/li><\/ul><\/li><\/ul><h3>\u00a0<\/h3><h3><strong>Making Sure You Remain MDD and MDR Compliant<\/strong><\/h3><p>Maximizing the ability of your existing MDD CE certificate is no doubt important, and thus, it\u2019s vital that you meet the MDR postmarket surveillance and other requirements applicable to legacy devices. Our team is ready to help ensure a smooth transition to the MDR for legacy (and new) devices. We offer\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-mdr-training\" target=\"_blank\" rel=\"noopener noreferrer\">MDR training<\/a>,\u00a0<a href=\"https:\/\/www.orielstat.com\/consulting\/New-EU-Medical-Device-Regulation\" target=\"_blank\" rel=\"noopener noreferrer\">transition support<\/a>,\u00a0<a href=\"https:\/\/www.orielstat.com\/consulting\/EU-MDR-gap-analysis-assessment\" target=\"_blank\" rel=\"noopener noreferrer\">gap assessments<\/a>, and more.<\/p>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a3400fd elementor-widget elementor-widget-shortcode\" data-id=\"a3400fd\" data-element_type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"elementor-shortcode\"><div class=\"container\">\n    <div class=\"col-lg-12 col-md-12\">\n        <h5 class=\"elementor-heading-title elementor-size-default\">Our team is here to help. <a href=\"javascript:void(0);\" rel=\"nofollow\" noindex=\"noindex\">Contact us online<\/a><\/h5>\n        <h5 class=\"elementor-heading-title elementor-size-default\">or<\/h5>\n        <h6 class=\"elementor-heading-title elementor-size-default\">Get answers right now. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>25 EU MDR Articles That Apply to Legacy MDD Medical Devices Right NOW Does this situation sound familiar?\u00a0You\u2019re sitting on an existing valid Medical Devices Directive (MDD) certificate that expires sometime before May 26, 2024. You assume that any obligations to meet the requirements under the Medical Device Regulation (MDR 2017\/745) don\u2019t apply until you [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5302,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[16],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/mdr-regs-apply-to-all\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"25 EU MDR Articles That Apply to Legacy MDD Medical Devices Right NOW Does this situation sound familiar?\u00a0You\u2019re sitting on an existing valid Medical Devices Directive (MDD) certificate that expires sometime before May 26, 2024. 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