{"id":6520,"date":"2026-05-22T12:11:10","date_gmt":"2026-05-22T06:41:10","guid":{"rendered":"https:\/\/operonstrategist.com\/?p=6520"},"modified":"2026-05-22T12:21:47","modified_gmt":"2026-05-22T06:51:47","slug":"eu-mdr-affected-ce-marking","status":"publish","type":"post","link":"https:\/\/operonstrategist.com\/za-en\/eu-mdr-affected-ce-marking\/","title":{"rendered":"EU-MDR Affected CE Marking: Complete Guide for Medical Device Manufacturers"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"6520\" class=\"elementor elementor-6520\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-34df1454 e-flex e-con-boxed e-con e-parent\" data-id=\"34df1454\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t<div class=\"elementor-element elementor-element-17024cbe e-con-full e-flex e-con e-child\" data-id=\"17024cbe\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-753dfa57 elementor-widget elementor-widget-heading\" data-id=\"753dfa57\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">EU-MDR Affected CE Marking: Complete Guide for Medical Device Manufacturers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-62341b0b elementor-widget elementor-widget-text-editor\" data-id=\"62341b0b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">All those devices sold in the European Union market must bear CE marking. EU-2017\/745 <\/span><span style=\"font-weight: 400;\">EU medical device regulation<\/span><span style=\"font-weight: 400;\"> was approved on 5th April 2017 by the European Union and EU authorized representative to cover the weakness and improve the safety, performance, and efficiency of medical devices marketed in the European Union. To ensure that the medical device can be marketed within all the markets of the EU, a device must have CE marking. The Canadian standards association is used only when an organization determines that the product meets the applicable standards.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-2e6b4cfc e-con-full e-flex e-con e-child\" data-id=\"2e6b4cfc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t<div class=\"elementor-element elementor-element-7f83c37a e-con-full e-flex e-con e-child\" data-id=\"7f83c37a\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-67b306ee elementor-widget elementor-widget-heading\" data-id=\"67b306ee\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Talk to our experts<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b6b6c78 elementor-widget elementor-widget-wpforms\" data-id=\"b6b6c78\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"wpforms.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div class=\"wpforms-container wpforms-container-full wpforms-render-modern\" id=\"wpforms-6203\"><form id=\"wpforms-form-6203\" class=\"wpforms-validate wpforms-form wpforms-ajax-form\" data-formid=\"6203\" method=\"post\" enctype=\"multipart\/form-data\" action=\"\/za-en\/wp-json\/wp\/v2\/posts\/6520\" data-token=\"f90f4c38808f666071d8a9e075fe13da\" data-token-time=\"1779911003\"><noscript class=\"wpforms-error-noscript\">Please enable JavaScript in your browser to complete this form.<\/noscript><div id=\"wpforms-error-noscript\" style=\"display: none;\">Please enable JavaScript in your browser to complete this form.<\/div><div class=\"wpforms-field-container\"><div id=\"wpforms-6203-field_1-container\" class=\"wpforms-field wpforms-field-name\" data-field-id=\"1\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_1\" aria-hidden=\"false\">Name <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"text\" id=\"wpforms-6203-field_1\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][1]\" placeholder=\"Name*\" aria-errormessage=\"wpforms-6203-field_1-error\" required><\/div>\t\t<div id=\"wpforms-6203-field_5-container\"\n\t\t\tclass=\"wpforms-field wpforms-field-text\"\n\t\t\tdata-field-type=\"text\"\n\t\t\tdata-field-id=\"5\"\n\t\t\t>\n\t\t\t<label class=\"wpforms-field-label\" for=\"wpforms-6203-field_5\" >Text Phone Name<\/label>\n\t\t\t<input type=\"text\" id=\"wpforms-6203-field_5\" class=\"wpforms-field-medium\" name=\"wpforms[fields][5]\" >\n\t\t<\/div>\n\t\t<div id=\"wpforms-6203-field_2-container\" class=\"wpforms-field wpforms-field-email\" data-field-id=\"2\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_2\" aria-hidden=\"false\">Email <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"email\" id=\"wpforms-6203-field_2\" class=\"wpforms-field-large wpforms-field-required\" name=\"wpforms[fields][2]\" placeholder=\"Email*\" spellcheck=\"false\" aria-errormessage=\"wpforms-6203-field_2-error\" required><\/div><div id=\"wpforms-6203-field_3-container\" class=\"wpforms-field wpforms-field-phone\" data-field-id=\"3\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_3\" aria-hidden=\"false\">Phone <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><input type=\"tel\" id=\"wpforms-6203-field_3\" class=\"wpforms-field-large wpforms-field-required wpforms-smart-phone-field\" data-rule-smart-phone-field=\"true\" name=\"wpforms[fields][3]\" placeholder=\"Phone*\" aria-label=\"Phone\" aria-errormessage=\"wpforms-6203-field_3-error\" required><\/div><div id=\"wpforms-6203-field_4-container\" class=\"wpforms-field wpforms-field-textarea\" data-field-id=\"4\"><label class=\"wpforms-field-label wpforms-label-hide\" for=\"wpforms-6203-field_4\" aria-hidden=\"false\">Paragraph Text <span class=\"wpforms-required-label\" aria-hidden=\"true\">*<\/span><\/label><textarea id=\"wpforms-6203-field_4\" class=\"wpforms-field-medium wpforms-field-required\" name=\"wpforms[fields][4]\" placeholder=\"Message\" aria-errormessage=\"wpforms-6203-field_4-error\" required><\/textarea><\/div><script>\n\t\t\t\t( function() {\n\t\t\t\t\tconst style = document.createElement( 'style' );\n\t\t\t\t\tstyle.appendChild( document.createTextNode( '#wpforms-6203-field_5-container { position: absolute !important; overflow: hidden !important; display: inline !important; height: 1px !important; width: 1px !important; z-index: -1000 !important; padding: 0 !important; } #wpforms-6203-field_5-container input { visibility: hidden; } #wpforms-conversational-form-page #wpforms-6203-field_5-container label { counter-increment: none; }' ) );\n\t\t\t\t\tdocument.head.appendChild( style );\n\t\t\t\t\tdocument.currentScript?.remove();\n\t\t\t\t} )();\n\t\t\t<\/script><\/div><!-- .wpforms-field-container --><div class=\"wpforms-submit-container\" ><input type=\"hidden\" name=\"wpforms[id]\" value=\"6203\"><input type=\"hidden\" name=\"page_title\" value=\"\"><input type=\"hidden\" name=\"page_url\" value=\"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts\/6520\"><input type=\"hidden\" name=\"url_referer\" value=\"\"><button type=\"submit\" name=\"wpforms[submit]\" id=\"wpforms-submit-6203\" class=\"wpforms-submit\" data-alt-text=\"Sending...\" data-submit-text=\"Submit\" aria-live=\"assertive\" value=\"wpforms-submit\">Submit<\/button><img decoding=\"async\" src=\"https:\/\/operonstrategist.com\/wp-content\/plugins\/wpforms\/assets\/images\/submit-spin.svg\" class=\"wpforms-submit-spinner\" style=\"display: none;\" width=\"26\" height=\"26\" alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-456252c5 e-flex e-con-boxed e-con e-parent\" data-id=\"456252c5\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2496f70 elementor-widget elementor-widget-text-editor\" data-id=\"2496f70\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE marking<\/span><\/a><span style=\"font-weight: 400;\"> is not under the control of any particular body; instead, the manufacturer is responsible for proper use. This rule applies to all devices, whether present in the market or whether they are in the development stage.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5e8437e9 elementor-widget elementor-widget-heading\" data-id=\"5e8437e9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is CE Marking as per EU MDR? \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-51de5b12 elementor-widget elementor-widget-text-editor\" data-id=\"51de5b12\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The CE stands for \u201cConformit\u00e9 Europ\u00e9enne\u201c, the French word for European conformity. It is a type of declaration made by the manufacturer to confirm that their product complied with the EU-MDR. With the CE mark, the manufacturer is eligible to sell their medical device in any EU member state. Thus, it is the responsibility of the manufacturer, whether inside the EU or outside the EU, they need to get their device CE-marked. Please do not confuse the CE mark with the quality mark; it is proof of compliance with EU-MDR 2017\/745. Manufacturers still need to meet the device\u2019s safety, performance, quality, and efficacy.\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-4b45796 elementor-widget elementor-widget-heading\" data-id=\"4b45796\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Products that must carry CE marking \u2013  \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a79c6c0 elementor-widget elementor-widget-text-editor\" data-id=\"a79c6c0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Electronics\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Toys\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Eyewear\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Protective Equipment\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Machines\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Medical devices <\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c8b2bf1 elementor-widget elementor-widget-heading\" data-id=\"c8b2bf1\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Difference Between MDD CE Marking and MDR CE Marking- \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-6d62f4c elementor-widget elementor-widget-text-editor\" data-id=\"6d62f4c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<table><tbody><tr><td><p><span style=\"font-weight: 400;\">MDD\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">MDR\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Annex I consists of 14 essential requirements and 54 subsets.\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Annex II to Annex VII describes six different routes to acquiring the CE marking.\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">In chapter \u2013 II\u00a0\u00a0<\/span><\/p><p><span style=\"font-weight: 400;\">Articles 5 to 24 \u2013 Making available on the market and putting into service devices, obligations of economic operators, reprocessing, CE marking, free movement.\u00a0<\/span><\/p><\/td><\/tr><tr><td><p><span style=\"font-weight: 400;\">Annex XII demonstrates how the CE marking should be applied.\u00a0<\/span><\/p><\/td><td><p><span style=\"font-weight: 400;\">Annex V explains the CE marking of conformity.\u00a0<\/span><\/p><\/td><\/tr><\/tbody><\/table>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5f7483d elementor-widget elementor-widget-heading\" data-id=\"5f7483d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Effect of EU-MDR on CE Marking- \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f78dc31 elementor-widget elementor-widget-text-editor\" data-id=\"f78dc31\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">There are many differences between MDD and MDR, as MDR is more detailed and comprehensive. MDR ensures that all medical device manufacturers have fair access to all the markets of the EU and that medical devices are safe, have high quality, transparent for customers, and have increased market surveillance. The changes in MDR have many aspects which will affect the CE marking process, which are given below:<\/span><\/p><h3><span style=\"font-weight: 400;\">Reclassification\u00a0<\/span><\/h3><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">In EU-MDR, medical devices are classified as per the risk they possess. Thus, it helps to determine the route for CE marking. While the overall classification of medical devices remains the same in MDR from class I to class III, EU-MDR reclassified some devices. So, from now, the manufacturers need to accurately classify their devices and determine which conformity route they need to follow. Thus, reclassified devices that were placed in the higher group due to their risk needed technical and clinical data as they may not be already available.\u00a0<\/span><\/li><\/ul><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">For the manufacturers of high-risk class devices such as class IIa, class IIb and class III, it is mandatory to involve a notified body to obtain the conformity assessment.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The class I device manufacturer can use the self-certify route to get the CE marking<\/span><\/li><\/ul><h3><span style=\"font-weight: 400;\">Clinical Evaluation Reports (CERs)\u00a0<\/span><\/h3><ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">CERs are the documents that contain clinical data related to the medical. The MDR has clearer information regarding the clinical evidence and evaluation (MDR Annex XIV, Part A). The use of scientific literature to establish equivalence has become stricter after this regulation, along with increased scrutiny of CER by notified bodies. It is important for manufacturers, especially class I medical devices, to ensure that CERs conform to new specifications. In class, I have less additional clinical data to support. <\/span><\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-a955e04 elementor-widget elementor-widget-heading\" data-id=\"a955e04\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Does My Device Fall Under Self-Certification? \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-d1951a3 elementor-widget elementor-widget-text-editor\" data-id=\"d1951a3\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The first and main step in determining the route for CE marking is classification, which depends on the intended use and risk involved. The class I medical devices are mostly nonsterile and do not have any measuring function; thus, do not require a notified body for conformity assessment.\u00a0<\/span><\/p><h3><span style=\"font-weight: 400;\">Validity of CE Marking<\/span><\/h3><p><span style=\"font-weight: 400;\">The MDR came into full effect in May 2021, and the CE certificates issued before MDR have validity for four years. The certificates issued after <\/span><span style=\"font-weight: 400;\">MDR implementation<\/span><span style=\"font-weight: 400;\"> have validity for three years. For some high risks devices, it is up to one year.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-659b6a9 elementor-widget elementor-widget-heading\" data-id=\"659b6a9\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Things to Keep in Mind While Affixing the CE Mark: \n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-9dc4b9c elementor-widget elementor-widget-text-editor\" data-id=\"9dc4b9c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<ul><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">It must be visible, legible, and permanent.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Must have the initials \u201cCE\u201d with the same vertical dimension and should not be less than 5mm (unless specified).\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">The manufacturer can use it in different forms if <\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\">CE marking<\/span><\/a><span style=\"font-weight: 400;\"> is visible.\u00a0<\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">Suppose the manufacturer cannot affix the CE marking on the medical device itself. In that case, it can be affixed to the packaging if there is any or can accompany the documents. Suppose the device is subjected to several EU directives. In that case, documents must indicate that the device conforms to all the applicable directives. <\/span><\/li><li style=\"font-weight: 400;\" aria-level=\"1\">Our technical experts can assist you in getting your medical devices CE-approved.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-88b0a52 elementor-widget elementor-widget-heading\" data-id=\"88b0a52\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Conclusion\n<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-068caea elementor-widget elementor-widget-text-editor\" data-id=\"068caea\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p><span style=\"font-weight: 400;\">The MDR has significantly changed how a CE mark certificate gets approved in Europe. The changes were extensive, and it took the organization time to implement the MDR fully. These changes have affected the manufacturer, their organization, and notified bodies. The<\/span><a href=\"https:\/\/operonstrategist.com\/services\/regulatory-approvals\/ce-marking\/\"><span style=\"font-weight: 400;\"> CE marking<\/span><\/a><span style=\"font-weight: 400;\"> is proof from the manufacturer that the medical device adheres to the EU-MDR. Thus, the manufacturer now needs to be more careful with it if they want to continue the business all over the European market. As <\/span><a href=\"https:\/\/operonstrategist.com\/\"><span style=\"font-weight: 400;\">medical device regulatory consultants<\/span><\/a><span style=\"font-weight: 400;\"> we guide manufacturers and help them to obtain CE marking medical devices.<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-706b33db elementor-widget elementor-widget-heading\" data-id=\"706b33db\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-457f0541 elementor-widget elementor-widget-n-accordion\" data-id=\"457f0541\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;default_state&quot;:&quot;all_collapsed&quot;,&quot;max_items_expended&quot;:&quot;one&quot;,&quot;n_accordion_animation_duration&quot;:{&quot;unit&quot;:&quot;ms&quot;,&quot;size&quot;:400,&quot;sizes&quot;:[]}}\" data-widget_type=\"nested-accordion.default\">\n\t\t\t\t\t\t\t<div class=\"e-n-accordion\" aria-label=\"Accordion. Open links with Enter or Space, close with Escape, and navigate with Arrow Keys\">\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1160\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"1\" tabindex=\"0\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1160\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What is EU MDR and how does it affect CE marking? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1160\" class=\"elementor-element elementor-element-1ead1c42 e-con-full e-flex e-con e-child\" data-id=\"1ead1c42\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-52aec47b elementor-widget elementor-widget-text-editor\" data-id=\"52aec47b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"144\" data-end=\"388\">EU MDR (Medical Device Regulation 2017\/745) is the updated European regulation that introduced stricter requirements for medical device safety, clinical evaluation, technical documentation, and post-market surveillance for obtaining CE marking.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1161\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"2\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1161\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Which medical devices are affected by EU MDR? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1161\" class=\"elementor-element elementor-element-33fe5b6b e-con-full e-flex e-con e-child\" data-id=\"33fe5b6b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-150b949d elementor-widget elementor-widget-text-editor\" data-id=\"150b949d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"448\" data-end=\"631\">EU MDR applies to most medical devices, including implants, diagnostic devices, software, reusable surgical instruments, and certain products previously exempt under older directives.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1162\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"3\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1162\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> What are the key changes introduced under EU MDR for CE marking? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1162\" class=\"elementor-element elementor-element-115f2540 e-con-full e-flex e-con e-child\" data-id=\"115f2540\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-684dca54 elementor-widget elementor-widget-text-editor\" data-id=\"684dca54\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"710\" data-end=\"732\">Major changes include:<\/p><ul data-start=\"733\" data-end=\"937\"><li data-section-id=\"1qxu341\" data-start=\"733\" data-end=\"778\">Stricter clinical evaluation requirements<\/li><li data-section-id=\"16m1uav\" data-start=\"779\" data-end=\"815\">Enhanced technical documentation<\/li><li data-section-id=\"ms4fsg\" data-start=\"816\" data-end=\"854\">Unique Device Identification (UDI)<\/li><li data-section-id=\"4g9ogu\" data-start=\"855\" data-end=\"893\">Increased post-market surveillance<\/li><li data-section-id=\"16i0c5w\" data-start=\"894\" data-end=\"937\">Stronger traceability and risk management<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1163\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"4\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1163\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> Is ISO 13485 required for EU MDR CE marking? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1163\" class=\"elementor-element elementor-element-7056a89b e-con-full e-flex e-con e-child\" data-id=\"7056a89b\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-2ecb7a19 elementor-widget elementor-widget-text-editor\" data-id=\"2ecb7a19\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"996\" data-end=\"1117\">Yes. ISO 13485 is highly important for demonstrating compliance with quality management system requirements under EU MDR.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t\t<details id=\"e-n-accordion-item-1164\" class=\"e-n-accordion-item\" >\n\t\t\t\t<summary class=\"e-n-accordion-item-title\" data-accordion-index=\"5\" tabindex=\"-1\" aria-expanded=\"false\" aria-controls=\"e-n-accordion-item-1164\" >\n\t\t\t\t\t<span class='e-n-accordion-item-title-header'><div class=\"e-n-accordion-item-title-text\"> How can medical device manufacturers prepare for EU MDR compliance? <\/div><\/span>\n\t\t\t\t\t\t\t<span class='e-n-accordion-item-title-icon'>\n\t\t\t<span class='e-opened' ><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-minus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h384c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t\t<span class='e-closed'><svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-plus\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M416 208H272V64c0-17.67-14.33-32-32-32h-32c-17.67 0-32 14.33-32 32v144H32c-17.67 0-32 14.33-32 32v32c0 17.67 14.33 32 32 32h144v144c0 17.67 14.33 32 32 32h32c17.67 0 32-14.33 32-32V304h144c17.67 0 32-14.33 32-32v-32c0-17.67-14.33-32-32-32z\"><\/path><\/svg><\/span>\n\t\t<\/span>\n\n\t\t\t\t\t\t<\/summary>\n\t\t\t\t<div role=\"region\" aria-labelledby=\"e-n-accordion-item-1164\" class=\"elementor-element elementor-element-65da7fc e-con-full e-flex e-con e-child\" data-id=\"65da7fc\" data-element_type=\"container\" data-e-type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5c88a92 elementor-widget elementor-widget-text-editor\" data-id=\"5c88a92\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t<p data-start=\"1199\" data-end=\"1220\">Manufacturers should:<\/p><ul data-start=\"1221\" data-end=\"1459\" data-is-last-node=\"\" data-is-only-node=\"\"><li data-section-id=\"1vgz7vc\" data-start=\"1221\" data-end=\"1255\">Update technical documentation<\/li><li data-section-id=\"1uegtgo\" data-start=\"1256\" data-end=\"1280\">Conduct gap analysis<\/li><li data-section-id=\"58ufqy\" data-start=\"1281\" data-end=\"1313\">Strengthen clinical evidence<\/li><li data-section-id=\"19s7wkn\" data-start=\"1314\" data-end=\"1360\">Implement post-market surveillance systems<\/li><li data-section-id=\"8krhpt\" data-start=\"1361\" data-end=\"1459\" data-is-last-node=\"\">Work with experienced regulatory consultants and notified bodies for smooth CE marking approval.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/details>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t<script type=\"application\/ld+json\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What is EU MDR and how does it affect CE marking?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"EU MDR (Medical Device Regulation 2017\\\/745) is the updated European regulation that introduced stricter requirements for medical device safety, clinical evaluation, technical documentation, and post-market surveillance for obtaining CE marking.\"}},{\"@type\":\"Question\",\"name\":\"Which medical devices are affected by EU MDR?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"EU MDR applies to most medical devices, including implants, diagnostic devices, software, reusable surgical instruments, and certain products previously exempt under older directives.\"}},{\"@type\":\"Question\",\"name\":\"What are the key changes introduced under EU MDR for CE marking?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Major changes include:Stricter clinical evaluation requirementsEnhanced technical documentationUnique Device Identification (UDI)Increased post-market surveillanceStronger traceability and risk management\"}},{\"@type\":\"Question\",\"name\":\"Is ISO 13485 required for EU MDR CE marking?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Yes. ISO 13485 is highly important for demonstrating compliance with quality management system requirements under EU MDR.\"}},{\"@type\":\"Question\",\"name\":\"How can medical device manufacturers prepare for EU MDR compliance?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Manufacturers should:Update technical documentationConduct gap analysisStrengthen clinical evidenceImplement post-market surveillance systemsWork with experienced regulatory consultants and notified bodies for smooth CE marking approval.\"}}]}<\/script>\n\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>All those devices sold in the European Union market must bear CE marking. EU-2017\/745 EU medical device regulation was approved on 5th April 2017 by the European Union and EU authorized representative to cover the weakness and improve the safety, performance, and efficiency of medical devices marketed in the European Union. To ensure that the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":6525,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[],"class_list":["post-6520","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical-device-manufacturing"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts\/6520","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/comments?post=6520"}],"version-history":[{"count":0,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/posts\/6520\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/media\/6525"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/media?parent=6520"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/categories?post=6520"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/operonstrategist.com\/za-en\/wp-json\/wp\/v2\/tags?post=6520"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}