{"id":7178,"date":"2023-02-14T18:55:14","date_gmt":"2023-02-14T18:55:14","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=7178"},"modified":"2024-01-12T21:34:49","modified_gmt":"2024-01-12T21:34:49","slug":"what-is-significant-change-mdr-article-120","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/what-is-significant-change-mdr-article-120\/","title":{"rendered":"What Is Considered a Significant Change Under EU MDR Article 120(3) and MDCG 2020-3?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"7178\" class=\"elementor elementor-7178\" 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-1b0c5cde elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"1b0c5cde\" 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-6dd05cd3\" data-id=\"6dd05cd3\" 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-7ca59751 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"7ca59751\" 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-6ea4084d\" data-id=\"6ea4084d\" 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-3fab5c3f elementor-widget elementor-widget-post-info\" data-id=\"3fab5c3f\" 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\/2023\/02\/14\/\">\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\tFebruary 14, 2023\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-5f16c1c2 elementor-widget elementor-widget-heading\" data-id=\"5f16c1c2\" 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\">What Is Considered a Significant Change Under EU MDR Article 120(3)?<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-1f7ff590 elementor-widget elementor-widget-image\" data-id=\"1f7ff590\" 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=\"1649\" height=\"929\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering.jpg\" class=\"attachment-full size-full wp-image-7060\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering.jpg 1649w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering-300x169.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering-1024x577.jpg 1024w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering-768x433.jpg 768w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering-1536x865.jpg 1536w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/12\/Men-Working-on-Engineering-500x282.jpg 500w\" sizes=\"(max-width: 1649px) 100vw, 1649px\" \/>\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-1005398 elementor-widget elementor-widget-text-editor\" data-id=\"1005398\" 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>The EU MDR imposes strict requirements on medical device companies marketing their products in Europe. Many device companies scrambled to renew existing CE certificates granted under the old Medical Devices Directive, allowing them to sell that device in Europe until those certificates expire or May 2024, whichever comes first.<\/p><p>Whatever the reason, companies need to be careful to make sure they do not make significant changes that would raise the ire of Notified Bodies and trigger a mandatory new EU MDR registration, or risk having to prematurely pull their product from the EU market. Let\u2019s consider an example.<\/p><p>Suppose you renewed an existing MDD certificate but want to make changes to the device before it expires? Well, you have two options, neither of them appealing:<\/p><p>\u00a0<\/p><ol><li>Pull the device off the market while you pursue CE certification under the EU MDR<\/li><li>Determine if the change is considered \u201csignificant\u201d and, if it is not, secure a derogation (permission) from your Notified Body to make the change<\/li><\/ol>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a1af7ef elementor-widget elementor-widget-heading\" data-id=\"a1af7ef\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">A Strong Need to Define \u201cSignificant\u201d <\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cb40341 elementor-widget elementor-widget-text-editor\" data-id=\"cb40341\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>It is important to highlight that no issuing of new AIMDD\/MDD certificates is allowed under Article 120(3c), point (b) MDR12 (see also section 4.1). Therefore, if the manufacturer wishes to make a \u2018significant change in design or intended purpose\u2019 within the meaning of Article 120(3c), point (b) MDR, the implementation of such a change would prevent the manufacturer from placing the device on the market under the AIMDD\/MDD in accordance with that provision.<\/p><p>Here\u2019s an excerpt from\u00a0<a href=\"http:\/\/ww2.orielstat.com\/rs\/231-KOL-532\/images\/EU-MDR-2017-745-Regulation-and-TOC.pdf\">Article 120 of the MDR<\/a>, which we have shortened for clarity:<\/p><p><em>\u201cBy way of derogation\u2026a device with a certificate that was issued in accordance with Directive 90\/385\/EEC or Directive 93\/42\/EEC\u2026may only be placed on the market \u2026\u00a0<\/em><strong><em>provided there are no significant changes in the design and intended purpose<\/em><\/strong><em>.\u201d\u00a0<\/em><\/p><p>Ok, this would seem to indicate that only changes to the\u00a0<strong><em><u>device design<\/u><\/em><\/strong>\u00a0and\u00a0<strong><em><u>intended purpose<\/u><\/em><\/strong>\u00a0count as \u201csignificant.\u201d That\u2019s not really true. (We\u2019ll get to that in a minute.) After the EU MDR was published, various industry groups understood that manufacturers might, shall we say, apply liberal interpretations of the word \u201csignificant.\u201d As such industry has been clamoring for official guidance that would add more specificity to Article 120. The Medical Device Coordination Group (MDCG) finally did so in releasing <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-05\/mdcg_2020-3_en.pdf\">MDCG 2020-3 revision 1 changes<\/a>. The main content of this document is contained in five decision trees focused on key areas of change:<\/p><p>Examples of Changes Outlined in MDCG 2020-3 That May Be Considered \u201cSignificant\u201d Under Article 120(3)<\/p><p>Here are some (but not all) common examples of changes that may be considered significant according to the guidance. Please study the guidance and consult with your Notified Body as their opinion may differ from yours.<\/p><p>\u00a0<\/p><p><strong>Chart A \u2013 Intended Purpose<\/strong><\/p><ul><li>Extension of the intended purpose, such as:<ul><li>additional or new indications;<\/li><li>\u00a0additional or new clinical conditions.<\/li><\/ul><\/li><li>New user or patient population, such as:<ul><li>additional or new target population;<\/li><li>additional or new user (e.g. change from professional use to layman use)<\/li><\/ul><\/li><li>New way of clinical application, such as:<ul><li>additional or new applications (different stage or severity of disease);<\/li><li>additional or new anatomical site;<\/li><li>new delivery pathway or deployment method.<\/li><\/ul><\/li><\/ul><p><strong>Chart B \u2013 Design or Performance Specification<\/strong><\/p><ul><li>Requires further clinical or usability data<\/li><li>New risks require control measures<\/li><li>Existing risks negatively affected<\/li><li>Change to built-in control mechanism<\/li><li>Change to operating principles, source of energy or alarms<\/li><\/ul><p><strong>Chart C \u2013 Software<\/strong><\/p><ul><li>New or major change to operating system or component<\/li><li>New\/modified architecture\/database structure<\/li><li>Change of algorithm (but not software bug fixes, security updates)<\/li><li>Required user input replaced by closed loop algorithm<\/li><li>New diagnostic or therapeutic features or new channel of interoperability<\/li><li>New user interface or presentation of data that impacts performance<\/li><\/ul><p><strong>Chart D \u2013 Materials<\/strong><\/p><ul><li>Change of material of human\/animal origin, including addition of new materials<\/li><li>Change to material containing a medicinal substance, or the substance itself<\/li><li>Manufacturing or other change that may impact quality, safety or efficacy of a medicinal substance<\/li><li>Ingredient or material from new supplier does not meet existing specification<\/li><\/ul><p><strong>Chart E \u2013 Sterilization\/Packaging<\/strong><\/p><ul><li>Change to terminal sterilization method<\/li><li>Design change that affects or changes sterility assurance<\/li><li>Packaging design change affects functionality, safety, stability or seal integrity<\/li><li>Shelf life change not validated by protocols approved by Notified Body<\/li><\/ul><p>Again, this is not a complete list so be sure to\u00a0download <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-05\/mdcg_2020-3_en.pdf\">MDCG 2020-3 Rev.1<\/a><\/p><p>\u00a0<\/p><h3>Changes to Your QMS Can Count as \u201cSignificant\u201d as Well!<\/h3><p>\u201cSignificant\u201d changes are not limited to changes in design and intended purpose. While most of the guidance focuses on changes to the device, materials, or its intended purpose, those are not the only changes a Notified Body may see as significant enough to invalidate an MDD CE certificate. Section 9.6 of\u00a0<a href=\"https:\/\/iaf.nu\/iaf_system\/uploads\/documents\/IAF_MD9_Issue_4_010220221.pdf\">this document<\/a>\u00a0issued by the International Accreditation Forum (IAF) in 2022 discusses QMS changes that Notified Bodies may consider significant. They include:<\/p><ul><li>Change in company ownership<\/li><li>Extension to manufacturing and\/or design control<\/li><li>New facility or line modification\/relocation<\/li><li>Significant modifications to special processes<\/li><li>Change in authority of the management representative<\/li><li>Postmarket surveillance and vigilance issues<\/li><li>Concerns about implementation or corrective actions<\/li><\/ul><h3>\u00a0<\/h3><h3>Here are some common examples of changes that could be deemed significant:<\/h3><ul><li>Making an insignificant design change to mitigate risks discovered during postmarket surveillance may constitute a significant change for that product.<\/li><li>Changing the floorplan of a manufacturing facility, especially for processes considered \u201cspecial\u201d or critical to the product. This could be considered a significant change, and it may require that the change be implemented in compliance with the regulations.<\/li><li>A manufacturer consolidates or centralizes a key system of their QMS (e.g., design control) across multiple sites.<\/li><\/ul>\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d78be8 elementor-widget elementor-widget-heading\" data-id=\"6d78be8\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Be Mindful of Changes and Their Impact<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ed9a568 elementor-widget elementor-widget-text-editor\" data-id=\"ed9a568\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>Manufacturers looking to extend the life of their MDD CE certification should always be mindful of the fact that Notified Body auditors will be examining their devices and processes through the lens of the EU MDR and ISO 13485:2016. Understanding which changes are allowable is critical before actually making them. When in doubt, talk to your Notified Body before considering any changes.<\/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-c822fb5 elementor-widget elementor-widget-heading\" data-id=\"c822fb5\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Want to Learn More?<\/h2>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b959ace elementor-widget elementor-widget-text-editor\" data-id=\"b959ace\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<p>We have two training classes that may interest you. This intensive\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/implementing-design-control-requirements-and-best-practices\">training class on medical device design control<\/a>\u00a0gives you an in-depth look at how to properly structure your QMS processes and manage changes.\u00a0 Our popular\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/eu-mdr-auditor-training-2017-745\">EU MDR auditor training class<\/a>\u00a0is also an excellent deep dive into all facets of 2017\/745. 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href=\"https:\/\/www.orielstat.com\/blog\/category\/capa-for-medical-devicecompliance\/\">CAPA and Root Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-14\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/us-fda-qsr\/\">FDA 21 CFR Part 820<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-21\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/510k-submissions\/\">FDA 510(k) Submissions<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-69\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/fda-eua\/\">FDA EUA<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-4\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/iso-134852016\/\">ISO 13485 QMS Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-30\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/risk-management-iso14971\/\">ISO 14971 Risk Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-40\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/laboratory-developed-tests-ldt\/\">Lab Developed Tests<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-66\"><a 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>What Is Considered a Significant Change Under EU MDR Article 120(3)? The EU MDR imposes strict requirements on medical device companies marketing their products in Europe. Many device companies scrambled to renew existing CE certificates granted under the old Medical Devices Directive, allowing them to sell that device in Europe until those certificates expire or [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":4314,"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>What Is Considered a Significant Change Under EU MDR Article 120(3) and MDCG 2020-3?<\/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\/what-is-significant-change-mdr-article-120\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"What Is Considered a Significant Change Under EU MDR Article 120(3) and MDCG 2020-3?\" \/>\r\n<meta property=\"og:description\" content=\"What Is Considered a Significant Change Under EU MDR Article 120(3)? The EU MDR imposes strict requirements on medical device companies marketing their products in Europe. 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The EU MDR imposes strict requirements on medical device companies marketing their products in Europe. Many device companies scrambled to renew existing CE certificates granted under the old Medical Devices Directive, allowing them to sell that device in Europe until those certificates expire or [&hellip;]","og_url":"https:\/\/www.orielstat.com\/blog\/what-is-significant-change-mdr-article-120\/","og_site_name":"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog","article_published_time":"2023-02-14T18:55:14+00:00","article_modified_time":"2024-01-12T21:34:49+00:00","og_image":[{"width":1773,"height":1182,"url":"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2021\/09\/man-looking-at-computer-screen-blog.jpeg","type":"image\/jpeg"}],"author":"usr192162","twitter_card":"summary_large_image","twitter_misc":{"Written by":"usr192162","Est. reading time":"6 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