{"id":44,"date":"2022-11-01T12:47:55","date_gmt":"2022-11-01T12:47:55","guid":{"rendered":"https:\/\/operonstrategist.com\/costarica\/?page_id=44"},"modified":"2025-09-18T12:04:00","modified_gmt":"2025-09-18T12:04:00","slug":"ce-marking","status":"publish","type":"page","link":"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/ce-marking\/","title":{"rendered":"CE Marking"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"44\" class=\"elementor elementor-44\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-2e9826fc banner-sec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"2e9826fc\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t\t\t\t\t<div class=\"elementor-background-overlay\"><\/div>\n\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-no\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-6c1d5f5f\" data-id=\"6c1d5f5f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-97afbfa banner-sec-heading elementor-widget elementor-widget-heading\" data-id=\"97afbfa\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h1 class=\"elementor-heading-title elementor-size-default\">CE Marking for Medical Devices in Brazil<\/h1>\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a5643a3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a5643a3\" data-element_type=\"section\" data-e-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-cedaaad\" data-id=\"cedaaad\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-b0858eb elementor-widget elementor-widget-heading\" data-id=\"b0858eb\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Trusted EU MDR &amp; IVDR Compliance Support for Brazilian Manufacturers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-447c46c elementor-widget elementor-widget-text-editor\" data-id=\"447c46c\" data-element_type=\"widget\" data-e-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\t\t<p data-start=\"361\" data-end=\"615\">Are you a medical device manufacturer in Brazil planning to export to Europe? To legally place your products on the European market, you must obtain CE Marking \u2014 proof that your device complies with EU safety, quality, and performance requirements. Operon Strategist supports Brazilian manufacturers in navigating EU MDR 2017\/745 and IVDR 2017\/746. From device classification to Notified Body coordination, we manage the complete CE Marking process, ensuring your device is fully compliant and ready for European commercialization.<\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4343b3e elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4343b3e\" data-element_type=\"section\" data-e-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-8e836c7\" data-id=\"8e836c7\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-bc30065 elementor-widget elementor-widget-heading\" data-id=\"bc30065\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">What is CE Marking for Medical Devices?<\/h2>\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-029e396 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"029e396\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-7a9c50f\" data-id=\"7a9c50f\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-1829996 elementor-widget elementor-widget-text-editor\" data-id=\"1829996\" data-element_type=\"widget\" data-e-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\t\t<p data-start=\"961\" data-end=\"1092\">CE Marking is a mandatory European conformity symbol that certifies your medical or IVD device meets EU regulatory standards.<\/p><p data-start=\"1094\" data-end=\"1144\">For Brazilian manufacturers, CE Marking enables:<\/p><ul><li data-start=\"1147\" data-end=\"1218\">Legal access to 30+ countries in the European Economic Area (EEA)<\/li><li data-start=\"1221\" data-end=\"1286\">International credibility and recognition of product safety<\/li><li data-start=\"1289\" data-end=\"1348\">Participation in EU tenders and reimbursement systems<\/li><li data-start=\"1351\" data-end=\"1383\">Regulatory approval under:<br \/>EU MDR 2017\/745 \u2013 for general medical devices<br \/>IVDR 2017\/746 \u2013 for in vitro diagnostic devices<\/li><\/ul>\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-a1e7ffd\" data-id=\"a1e7ffd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-daaa05d elementor-widget elementor-widget-image\" data-id=\"daaa05d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"1024\" height=\"510\" src=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/09\/CE-Marking-for-Medical-Devices-01-1-1024x510.jpg\" class=\"attachment-large size-large wp-image-3919\" alt=\"CE Marking for Medical Devices in Brazil\" srcset=\"https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/09\/CE-Marking-for-Medical-Devices-01-1-1024x510.jpg 1024w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/09\/CE-Marking-for-Medical-Devices-01-1-300x150.jpg 300w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/09\/CE-Marking-for-Medical-Devices-01-1-768x383.jpg 768w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/09\/CE-Marking-for-Medical-Devices-01-1-1536x766.jpg 1536w, https:\/\/operonstrategist.com\/en-br\/wp-content\/uploads\/2025\/09\/CE-Marking-for-Medical-Devices-01-1-2048x1021.jpg 2048w\" sizes=\"(max-width: 1024px) 100vw, 1024px\" \/>\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\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-8e9c965 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"8e9c965\" data-element_type=\"section\" data-e-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-50 elementor-top-column elementor-element elementor-element-3df67e5\" data-id=\"3df67e5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-0a5fd22 elementor-widget elementor-widget-heading\" data-id=\"0a5fd22\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Step-by-Step: CE Marking Process for Brazilian Manufacturers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-71bc562 elementor-widget elementor-widget-text-editor\" data-id=\"71bc562\" data-element_type=\"widget\" data-e-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\t\t<ul><li data-start=\"2652\" data-end=\"2749\"><strong data-start=\"2652\" data-end=\"2676\">Classify Your Device<\/strong> \u2013 Identify correct risk category (Class I, IIa, IIb, III, or IVD A\u2013D).<\/li><li data-start=\"2753\" data-end=\"2845\"><strong data-start=\"2753\" data-end=\"2771\">Appoint a PRRC<\/strong> \u2013 Person Responsible for Regulatory Compliance (per EU MDR Article 15).<\/li><li data-start=\"2849\" data-end=\"2918\"><strong data-start=\"2849\" data-end=\"2876\">Implement <a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/iso-13485-qms-medical-device\/\">ISO 13485<\/a> QMS<\/strong> \u2013 With ISO 14971-based risk management.<\/li><li data-start=\"2922\" data-end=\"3039\"><strong data-start=\"2922\" data-end=\"2957\">Prepare Technical Documentation<\/strong> \u2013 Including device specs, design files, CER, PMS plan, risk management reports.<\/li><li data-start=\"3043\" data-end=\"3126\"><strong data-start=\"3043\" data-end=\"3077\">Supplier &amp; Production Controls<\/strong> \u2013 Maintain traceability and quality standards.<\/li><li data-start=\"3130\" data-end=\"3221\"><strong data-start=\"3130\" data-end=\"3161\">Conduct Clinical Evaluation<\/strong> \u2013 Demonstrate safety and performance using clinical data.<\/li><li data-start=\"3225\" data-end=\"3307\"><strong data-start=\"3225\" data-end=\"3265\">Appoint EU Authorized Representative<\/strong> \u2013 Required for all Brazilian exporters.<\/li><li data-start=\"3311\" data-end=\"3388\"><strong data-start=\"3311\" data-end=\"3344\">Coordinate with Notified Body<\/strong> \u2013 For Class IIa, IIb, III, and IVD B\/C\/D.<\/li><li data-start=\"3392\" data-end=\"3474\"><strong data-start=\"3392\" data-end=\"3436\">Issue EU Declaration of Conformity (DoC)<\/strong> \u2013 Declare compliance with MDR\/IVDR.<\/li><li data-start=\"3479\" data-end=\"3554\"><strong data-start=\"3479\" data-end=\"3515\">Register in EUDAMED &amp; Assign UDI<\/strong> \u2013 Meet EU traceability requirements.<\/li><li data-start=\"3559\" data-end=\"3631\"><strong data-start=\"3559\" data-end=\"3576\">Affix CE Mark<\/strong> \u2013 Apply correct CE labeling on device and packaging.<\/li><li data-start=\"3636\" data-end=\"3729\"><strong data-start=\"3636\" data-end=\"3670\">Post-Market Surveillance (PMS)<\/strong> \u2013 Collect real-world data and ensure ongoing compliance.<\/li><\/ul>\t\t\t\t\t\t\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<div class=\"elementor-column elementor-col-50 elementor-top-column elementor-element elementor-element-f4bef52\" data-id=\"f4bef52\" data-element_type=\"column\" data-e-type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-51cd74c elementor-widget elementor-widget-heading\" data-id=\"51cd74c\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h4 class=\"elementor-heading-title elementor-size-default\">Let's Grow Your Business Together<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-0a5ff84 elementor-widget elementor-widget-wpforms\" data-id=\"0a5ff84\" 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alt=\"Loading\"><\/div><\/form><\/div>  <!-- .wpforms-container -->\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-02312cb elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"02312cb\" data-element_type=\"section\" data-e-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-1a92f47\" data-id=\"1a92f47\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d460006 elementor-widget elementor-widget-heading\" data-id=\"d460006\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why CE Marking Matters for Brazilian Exporters<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-626b386 elementor-widget elementor-widget-text-editor\" data-id=\"626b386\" data-element_type=\"widget\" data-e-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\t\t<ul><li data-start=\"1558\" data-end=\"1595\">Mandatory for EU Market Entry<\/li><li data-start=\"1598\" data-end=\"1651\">Proves Safety, Quality &amp; Clinical Performance<\/li><li data-start=\"1654\" data-end=\"1694\">Boosts International Recognition<\/li><li data-start=\"1697\" data-end=\"1752\">Enables Insurance Reimbursement &amp; Tender Access<\/li><li data-start=\"1755\" data-end=\"1811\">Strengthens Trust with Regulators &amp; Stakeholders<\/li><\/ul>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-657dab2 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"657dab2\" data-element_type=\"section\" data-e-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-428fb54\" data-id=\"428fb54\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-26c6787 elementor-widget elementor-widget-heading\" data-id=\"26c6787\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">CE Marking Services Tailored by Device Class<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b303d62 elementor-widget elementor-widget-text-editor\" data-id=\"b303d62\" data-element_type=\"widget\" data-e-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\t\t<h6 data-start=\"1869\" data-end=\"1894\">Class I Devices<\/h6><ul><li data-start=\"1897\" data-end=\"1925\">Self-certification support<\/li><li data-start=\"1928\" data-end=\"1965\">Technical documentation preparation<\/li><li data-start=\"1968\" data-end=\"2001\">Labeling &amp; packaging compliance<\/li><li data-start=\"2004\" data-end=\"2045\">Post-Market Surveillance (PMS) planning<\/li><\/ul><h6 data-start=\"2047\" data-end=\"2080\">Class IIa &amp; IIb Devices<\/h6><ul><li data-start=\"2083\" data-end=\"2128\">Clinical evaluation &amp; risk-benefit analysis<\/li><li data-start=\"2131\" data-end=\"2157\">Notified Body submission<\/li><li data-start=\"2160\" data-end=\"2192\">Vigilance &amp; PMS implementation<\/li><\/ul><h6 data-start=\"2194\" data-end=\"2221\">Class III Devices<\/h6><ul><li data-start=\"2224\" data-end=\"2257\">Clinical investigation guidance<\/li><li data-start=\"2260\" data-end=\"2287\">Expert panel consultation<\/li><li data-start=\"2290\" data-end=\"2323\">Comprehensive QMS documentation<\/li><\/ul><h6 data-start=\"2325\" data-end=\"2369\">In Vitro Diagnostic Devices (IVDs)<\/h6><ul><li data-start=\"2372\" data-end=\"2410\">Risk classification (A\u2013D under IVDR)<\/li><li data-start=\"2413\" data-end=\"2445\">Performance evaluation support<\/li><li data-start=\"2448\" data-end=\"2489\">Annex II\/III technical file preparation<\/li><li data-start=\"2492\" data-end=\"2536\">Notified Body coordination for Class B\/C\/D<\/li><li data-start=\"2539\" data-end=\"2575\">Post-market performance evaluation<\/li><\/ul>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-4d9b730 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"4d9b730\" data-element_type=\"section\" data-e-type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;classic&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-100 elementor-top-column elementor-element elementor-element-12540de2\" data-id=\"12540de2\" data-element_type=\"column\" data-e-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<div class=\"elementor-element elementor-element-26647111 elementor-widget elementor-widget-heading\" data-id=\"26647111\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Need CE Marking Support in Brazil? Contact Operon Strategist Now!<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a9f4e6d elementor-align-center elementor-widget elementor-widget-button\" data-id=\"7a9f4e6d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<div class=\"elementor-button-wrapper\">\n\t\t\t\t\t<a class=\"elementor-button elementor-button-link elementor-size-sm\" href=\"https:\/\/operonstrategist.com\/en-br\/contact-us\/\">\n\t\t\t\t\t\t<span class=\"elementor-button-content-wrapper\">\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-button-text\">Contact us<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-3922e6a elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"3922e6a\" data-element_type=\"section\" data-e-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-88c2095\" data-id=\"88c2095\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4941d2e elementor-widget elementor-widget-heading\" data-id=\"4941d2e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Why Choose Operon Strategist for CE Marking in Brazil?<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-5bba2d9 elementor-widget elementor-widget-text-editor\" data-id=\"5bba2d9\" data-element_type=\"widget\" data-e-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\t\t<p data-start=\"3797\" data-end=\"3954\">Operon Strategist is a global regulatory consulting partner helping Brazilian medical device and IVD manufacturers achieve CE Marking under MDR &amp; IVDR.<\/p><p data-start=\"3956\" data-end=\"4003\">We provide end-to-end support, including:<\/p><ul><li data-start=\"4006\" data-end=\"4051\">Device classification &amp; regulatory strategy<\/li><li data-start=\"4054\" data-end=\"4084\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/iso-13485-qms-medical-device\/\">ISO 13485 QMS implementation<\/a><\/li><li data-start=\"4087\" data-end=\"4130\">Technical documentation &amp; CER preparation<\/li><li data-start=\"4133\" data-end=\"4166\">Clinical evaluation &amp; PMS setup<\/li><li data-start=\"4169\" data-end=\"4197\">Notified Body coordination<\/li><li data-start=\"4200\" data-end=\"4238\">EU Authorized Representative support<\/li><\/ul><p data-start=\"4240\" data-end=\"4431\">With over a decade of international consulting experience and collaborations with EU Notified Bodies, we ensure faster, cost-effective, and compliant CE Marking for Brazilian exporters.<\/p>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-85c6344 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"85c6344\" data-element_type=\"section\" data-e-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-5bd6060\" data-id=\"5bd6060\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-52e8d612 elementor-widget elementor-widget-heading\" data-id=\"52e8d612\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Additional Regulatory Services by Operon Strategist<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7f67d6cf elementor-widget elementor-widget-text-editor\" data-id=\"7f67d6cf\" data-element_type=\"widget\" data-e-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\t\t<p data-start=\"4495\" data-end=\"4567\">Beyond CE Marking, we assist global medical device manufacturers with:<\/p><ul><li data-start=\"4570\" data-end=\"4604\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/anvisa-medical-device-registration-in-brazil\/\">ANVISA Registration<\/a> (Brazil)<\/li><li data-start=\"4607\" data-end=\"4637\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/fda-510-k\/\">US FDA 510(k) Submission<\/a><\/li><li data-start=\"4640\" data-end=\"4672\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/cdsco-registration\/\">CDSCO Registration<\/a> (India)<\/li><li data-start=\"4675\" data-end=\"4709\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/regulatory-approvals\/sfda-approval\/\">SFDA Approval<\/a> (Saudi Arabia)<\/li><li data-start=\"4712\" data-end=\"4752\"><a href=\"https:\/\/operonstrategist.com\/en-za\/services\/regulatory-approvals\/south-african-health-products-regulatory-authority-sahpra\/\">SAHPRA Registration<\/a> (South Africa)<\/li><li data-start=\"4755\" data-end=\"4783\"><a href=\"https:\/\/operonstrategist.com\/en-eg\/services\/regulatory-approvals\/eda-registration\/\">EDA Compliance<\/a> (Egypt)<\/li><\/ul><p data-start=\"4785\" data-end=\"4809\">We also specialize in:<\/p><ul><li data-start=\"4812\" data-end=\"4856\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\">Turnkey medical device manufacturing setup<\/a><\/li><li data-start=\"4859\" data-end=\"4902\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/validation-documentation\/\">Validation documentation<\/a> (DQ, IQ, OQ, PQ)<\/li><li data-start=\"4905\" data-end=\"4946\"><a href=\"https:\/\/operonstrategist.com\/en-br\/services\/turnkey-project-consultants\/product-feasibility-detail-project-report\/\">Feasibility studies &amp; business planning<\/a><\/li><\/ul>\t\t\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d785e32 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d785e32\" data-element_type=\"section\" data-e-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-627670a\" data-id=\"627670a\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-dbdf216 elementor-widget elementor-widget-heading\" data-id=\"dbdf216\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">FAQ'S<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-646abad elementor-widget elementor-widget-shortcode\" data-id=\"646abad\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"shortcode.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-shortcode\"><div id=\"rank-math-rich-snippet-wrapper\"><div id=\"rank-math-faq\" class=\"rank-math-block\">\n<div class=\"rank-math-list \">\n<div id=\"faq-1\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What is CE Marking and who needs it in Brazil?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Any Brazilian manufacturer exporting medical or IVD devices to Europe must obtain CE Marking for MDR\/IVDR compliance.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-2\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">How long does CE Marking take?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Typically 6\u201312 months, depending on device class and documentation.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-3\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Can you assist with Class III or IVD Class D devices?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Yes. We coordinate with Notified Bodies and provide expert regulatory guidance.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-4\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">What are the CE Marking costs?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Costs vary depending on device type and Notified Body involvement. Request a custom quote.<\/p>\n\n<\/div>\n<\/div>\n<div id=\"faq-5\" class=\"rank-math-list-item\">\n<h3 class=\"rank-math-question \">Do I need an EU Authorized Representative?<\/h3>\n<div class=\"rank-math-answer \">\n\n<p>Yes. Non-EU manufacturers, including those in Brazil, must appoint an EU Authorized Representative. Operon can assist.<\/p>\n\n<\/div>\n<\/div>\n<\/div>\n<\/div><\/div><\/div>\n\t\t\t\t\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<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>CE Marking for Medical Devices in Brazil Trusted EU MDR &amp; IVDR Compliance Support for Brazilian Manufacturers Are you a medical device manufacturer in Brazil planning to export to Europe? To legally place your products on the European market, you must obtain CE Marking \u2014 proof that your device complies with EU safety, quality, and [&hellip;]<\/p>\n","protected":false},"author":9,"featured_media":3919,"parent":20,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"unboxed","site-sidebar-style":"unboxed","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-44","page","type-page","status-publish","has-post-thumbnail","hentry"],"_links":{"self":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/44","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/users\/9"}],"replies":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/comments?post=44"}],"version-history":[{"count":5,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/44\/revisions"}],"predecessor-version":[{"id":3923,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/44\/revisions\/3923"}],"up":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/pages\/20"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media\/3919"}],"wp:attachment":[{"href":"https:\/\/operonstrategist.com\/en-br\/wp-json\/wp\/v2\/media?parent=44"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}