{"id":3706,"date":"2026-08-11T14:42:21","date_gmt":"2026-08-11T14:42:21","guid":{"rendered":"https:\/\/sanyangmedical.com\/ce-marking-medical-device-step-by-step\/"},"modified":"2026-09-05T19:31:14","modified_gmt":"2026-09-05T19:31:14","slug":"ce-marking-medical-device-step-by-step","status":"publish","type":"post","link":"https:\/\/sanyangmedical.com\/fr\/ce-marking-medical-device-step-by-step\/","title":{"rendered":"CE Marking Step by Step for Imported Medical Devices"},"content":{"rendered":"<p>Importing medical devices into the European Union requires CE marking \u2014 a conformity mark that signals the product meets the EU Medical Device Regulation (MDR 2017\/745). For manufacturers and distributors outside Europe, the CE marking process involves multiple steps, specific documentation, and engagement with a Notified Body. Getting it wrong means customs rejection, market withdrawal, or legal liability.<\/p>\n<p>For the parallel route into Great Britain, see our <a href=\"https:\/\/sanyangmedical.com\/ukca-uk-mdr-2002-great-britain\/\">UKCA and UK MDR 2002 guide<\/a>.<\/p>\n<p>This guide walks through each step of CE marking for imported medical devices, from device classification to post-market surveillance, with practical details on timelines, costs, and common pitfalls that delay market entry.<\/p>\n<p><img decoding=\"async\" class=\"wp-image-3256\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/iec-featured-lab.png\" alt=\"Medical device safety testing laboratory where CE marking compliance tests are performed\" width=\"1536\" height=\"1024\" loading=\"lazy\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/iec-featured-lab.png 1536w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/iec-featured-lab-300x200.png 300w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/iec-featured-lab-1024x683.png 1024w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/iec-featured-lab-768x512.png 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/iec-featured-lab-18x12.png 18w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><\/p>\n<div class=\"yt-facade\" data-yt-id=\"TYAPsGQ8uGg\" role=\"button\" tabindex=\"0\" aria-label=\"Play video: What is CE Marking?\"><\/div>\n<p><script>(function(){var f=document.querySelector('.yt-facade');if(!f)return;f.innerHTML='<iframe style=\"width:100%;aspect-ratio:16\/9;border:none\" src=\"https:\/\/www.youtube.com\/embed\/'+f.dataset.ytId+'?autoplay=1\" title=\"YouTube video\" allow=\"accelerometer;autoplay;clipboard-write;encrypted-media;gyroscope;picture-in-picture\" allowfullscreen><\/iframe>';})();<\/script><\/p>\n<h2>Step 1: Determine Device Classification<\/h2>\n<p>Every CE marking process starts with classification. Under EU MDR 2017\/745, medical devices are classified into four risk categories based on their intended use, invasiveness, and duration of contact with the body:<\/p>\n<ul style=\"font-size:15px!important;\">\n<li><strong>Class I (Low Risk):<\/strong> Non-invasive devices like examination gloves, stethoscopes, and manual surgical instruments. Self-certification is permitted \u2014 the manufacturer declares conformity without Notified Body involvement.<\/li>\n<li><strong>Class IIa (Medium-Low Risk):<\/strong> Invasive devices used for less than 60 minutes, or active therapeutic devices. Examples: surgical lights, suction pumps, anesthesia masks. Requires Notified Body audit.<\/li>\n<li><strong>Class IIb (Medium-High Risk):<\/strong> Invasive devices used for longer durations, or devices that administer energy to the body. Examples: operating tables with electrical adjustment, laser surgical units, ventilators. Requires Notified Body audit with type examination.<\/li>\n<li><strong>Class III (High Risk):<\/strong> Implantable devices, life-supporting equipment, and devices incorporating medicinal substances. Examples: cardiac pacemakers, hip implants. Full quality system assessment plus design examination by Notified Body.<\/li>\n<\/ul>\n<p>Misclassification is the single most common reason for CE marking delays. The <a href=\"\/eu-mdr-device-classification-class-i-iia-iib\/\">EU MDR device classification guide<\/a> provides a detailed decision tree for determining the correct class based on MDR Annex VIII rules.<\/p>\n<h2>Step 2: Appoint an EU Authorized Representative<\/h2>\n<p>Non-EU manufacturers must appoint an Authorized Representative (AR) established within the European Union. The AR acts as the regulatory contact point for EU competent authorities and holds specific legal responsibilities:<\/p>\n<ul style=\"font-size:15px!important;\">\n<li>Maintaining the Technical Documentation available for competent authority review<\/li>\n<li>Holding a copy of the EU Declaration of Conformity and the EU certificate<\/li>\n<li>Registering the device in the EUDAMED database on behalf of the manufacturer<\/li>\n<li>Complying with registration obligations and reporting serious incidents<\/li>\n<\/ul>\n<p>The AR agreement must be signed before submitting to a Notified Body. Choose an AR with experience in your device category \u2014 they will be asked to verify your technical documentation and may flag gaps before submission.<\/p>\n<h2>Step 3: Prepare Technical Documentation<\/h2>\n<p>The Technical File (or Technical Documentation) is the evidentiary backbone of your CE marking application. Under MDR Annex II and III, it must include:<\/p>\n<ol style=\"font-size:15px!important;\">\n<li><strong>Device description and specification<\/strong> \u2014 intended purpose, variants, accessories, operating principles<\/li>\n<li><strong>Design information<\/strong> \u2014 drawings, manufacturing processes, diagrams of components and materials<\/li>\n<li><strong>Risk management file<\/strong> \u2014 ISO 14971 risk analysis, evaluation, and control measures<\/li>\n<li><strong>Verification and validation reports<\/strong> \u2014 bench testing, biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2)<\/li>\n<li><strong>Clinical evaluation report<\/strong> \u2014 literature review or clinical investigation data supporting safety and performance claims<\/li>\n<li><strong>Labeling and IFU<\/strong> \u2014 symbols per ISO 15223-1, UDI assignment, language requirements per member state<\/li>\n<li><strong>Post-Market Surveillance plan<\/strong> \u2014 how you will collect and analyze post-market data<\/li>\n<\/ol>\n<p>The <a href=\"\/mdr-technical-documentation-eu-importers\/\">MDR technical documentation guide for EU importers<\/a> covers what importers should verify in the manufacturer&#8217;s technical file before placing products on the EU market.<\/p>\n<p>For importers sourcing from Chinese manufacturers, the <a href=\"\/solutions\/oem-odm-localization\/\">Sanyang Medical OEM\/ODM localization service<\/a> covers how CE + ISO 13485 compliant production, labeling, and documentation support are handled for EU-bound devices.<\/p>\n<\/p>\n<p><img decoding=\"async\" class=\"wp-image-2904\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w.webp\" alt=\"Medical device production line with quality management system for CE marking compliance\" width=\"1920\" height=\"1920\" loading=\"lazy\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w.webp 1920w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w-300x300.webp 300w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w-1024x1024.webp 1024w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w-150x150.webp 150w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w-768x768.webp 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w-1536x1536.webp 1536w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-operating-table-factory-photo-hotel-1920w-12x12.webp 12w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/p>\n<h2>Step 4: Engage a Notified Body<\/h2>\n<p>For Class IIa, IIb, and III devices, a Notified Body (NB) must assess your conformity. The NB is an independent organization designated by an EU member state to evaluate medical device compliance.<\/p>\n<p>Key considerations when selecting a Notified Body:<\/p>\n<ul style=\"font-size:15px!important;\">\n<li><strong>Designation scope<\/strong> \u2014 the NB must be designated for your specific device type and classification. Not all NBs cover all categories.<\/li>\n<li><strong>Location and language<\/strong> \u2014 while any EU NB can certify any device, working with one that speaks your language and understands your market reduces communication delays.<\/li>\n<li><strong>Timeline<\/strong> \u2014 current NB waiting times range from 6 to 18 months depending on device class and NB workload. Plan your submission well in advance of your target market entry date.<\/li>\n<li><strong>Cost<\/strong> \u2014 NB fees vary significantly. Initial certification for Class IIa typically costs \u20ac15,000\u201330,000; Class IIb ranges from \u20ac25,000\u201360,000. Annual surveillance audits add \u20ac8,000\u201315,000 per year.<\/li>\n<\/ul>\n<p>The <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector_en\" rel=\"noopener\" target=\"_blank\">European Commission medical devices sector page<\/a> is the official reference for the MDR text, guidance documents, and implementation timelines manufacturers use when navigating CE marking alongside other regulatory pathways.<\/p>\n<h2>Step 5: Conformity Assessment Route<\/h2>\n<p>The MDR defines several conformity assessment routes depending on device class:<\/p>\n<table style=\"width:100%;border-collapse:collapse;margin:1.5em 0;\">\n<thead>\n<tr style=\"background:#f0f4f8;\">\n<th style=\"padding:10px;border:1px solid #ddd;text-align:left;\">Class<\/th>\n<th style=\"padding:10px;border:1px solid #ddd;text-align:left;\">Assessment Route<\/th>\n<th style=\"padding:10px;border:1px solid #ddd;text-align:left;\">Notified Body Role<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td style=\"padding:10px;border:1px solid #ddd;\">Class I<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">Self-certification (Annex IV)<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">Not required (unless sterile or measuring)<\/td>\n<\/tr>\n<tr>\n<td style=\"padding:10px;border:1px solid #ddd;\">Class IIa<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">QMS audit (Annex IX) or Type exam (Annex X) + QMS (Annex XI)<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">Required \u2014 audits manufacturing QMS and reviews technical documentation<\/td>\n<\/tr>\n<tr>\n<td style=\"padding:10px;border:1px solid #ddd;\">Class IIb<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">QMS audit (Annex IX) or Type exam + Production QMS (Annex X + XI)<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">Required \u2014 full design review plus QMS audit<\/td>\n<\/tr>\n<tr>\n<td style=\"padding:10px;border:1px solid #ddd;\">Class III<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">QMS audit (Annex IX) with design examination<\/td>\n<td style=\"padding:10px;border:1px solid #ddd;\">Required \u2014 most rigorous assessment including clinical data review<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Most surgical equipment manufacturers fall into Class IIa or IIb. The <a href=\"\/iso-13485-vs-iso-9001-which-certificates-matter\/\">ISO 13485 vs ISO 9001 comparison<\/a> explains which quality management standard your NB will audit against.<\/p>\n<h2>Step 6: Issue EU Declaration of Conformity<\/h2>\n<p>Once the Notified Body issues a positive assessment, the manufacturer signs the EU Declaration of Conformity (DoC). This legal document states that the device meets all applicable requirements of the MDR. It must include:<\/p>\n<ul style=\"font-size:15px!important;\">\n<li>Manufacturer name and address<\/li>\n<li>Authorized Representative name and address<\/li>\n<li>Device name, model, and classification<\/li>\n<li>Notified Body name, number, and certificate reference<\/li>\n<li>Conformity assessment procedure used<\/li>\n<li>Harmonized standards applied (e.g., IEC 60601-1, ISO 14971)<\/li>\n<\/ul>\n<p>The DoC must be kept for the lifetime of the device plus 10 years (15 years for implantable devices).<\/p>\n<h2>Step 7: Register in EUDAMED and Affix CE Mark<\/h2>\n<p>The final steps before placing the device on the EU market:<\/p>\n<ol style=\"font-size:15px!important;\">\n<li><strong>EUDAMED registration<\/strong> \u2014 register the manufacturer, Authorized Representative, and device in the European Database on Medical Devices. Your AR typically handles this.<\/li>\n<li><strong>Assign UDI<\/strong> \u2014 the Unique Device Identifier must be placed on the device label and submitted to EUDAMED.<\/li>\n<li><strong>Affix CE mark<\/strong> \u2014 the CE logo must be visible, legible, and indelible on the device or its packaging. If the Notified Body was involved, their 4-digit identification number follows the CE mark.<\/li>\n<\/ol>\n<p>The <a href=\"\/ce-vs-iso-13485-medical\/\">CE marking vs ISO 13485 guide<\/a> clarifies the common confusion between product certification (CE mark) and quality system certification (ISO 13485) \u2014 both are required but serve different purposes.<\/p>\n<p><img decoding=\"async\" class=\"wp-image-3148\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w.webp\" alt=\"Factory quality inspection of medical devices before CE marking certification and export\" width=\"1920\" height=\"1920\" loading=\"lazy\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w.webp 1920w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w-300x300.webp 300w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w-1024x1024.webp 1024w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w-150x150.webp 150w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w-768x768.webp 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w-1536x1536.webp 1536w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-abs-emergency-trolley-factory-photo-india-1920w-12x12.webp 12w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/p>\n<h2>Post-Market Obligations<\/h2>\n<p>CE marking is not a one-time event. After market entry, manufacturers must maintain compliance through:<\/p>\n<ul style=\"font-size:15px!important;\">\n<li><strong>Post-Market Surveillance (PMS)<\/strong> \u2014 systematic collection and analysis of data on device performance in clinical use<\/li>\n<li><strong>Periodic Safety Update Reports (PSUR)<\/strong> \u2014 for Class IIa (every 2 years) and Class IIb\/III (annually)<\/li>\n<li><strong>Vigilance reporting<\/strong> \u2014 serious incidents and field safety corrective actions must be reported to competent authorities within defined timelines<\/li>\n<li><strong>Notified Body surveillance audits<\/strong> \u2014 annual unannounced audits plus scheduled recertification every 5 years<\/li>\n<\/ul>\n<p>The <a href=\"\/medical-device-vigilance-reporting-guide\/\">medical device vigilance reporting guide<\/a> provides a detailed timeline and template for reporting serious incidents under MDR requirements.<\/p>\n<h2>Common Pitfalls and How to Avoid Them<\/h2>\n<p>Based on experience guiding manufacturers through CE marking, these are the most frequent delays:<\/p>\n<ol style=\"font-size:15px!important;\">\n<li><strong>Incomplete clinical evaluation<\/strong> \u2014 the Notified Body rejects the application because the clinical data does not support all claimed indications. Solution: engage a clinical evaluator early in the documentation process.<\/li>\n<li><strong>Wrong device classification<\/strong> \u2014 self-classifying as Class I when the device should be Class IIa. Solution: use the MDR Annex VIII decision rules systematically, or engage a regulatory consultant.<\/li>\n<li><strong>Missing post-market documentation<\/strong> \u2014 PMS plan and PSUR template are often overlooked in initial submissions. Solution: prepare these alongside the technical file, not as an afterthought.<\/li>\n<li><strong>Inadequate Authorized Representative<\/strong> \u2014 choosing an AR without relevant device experience leads to documentation gaps. Solution: verify the AR&#8217;s track record with your device category before signing.<\/li>\n<\/ol>\n<p>For manufacturers preparing their first CE marking application, the <a href=\"\/pre-shipment-inspection-medical-equipment\/\">pre-shipment inspection guide<\/a> covers how quality checks before export align with MDR production quality requirements.<\/p>\n<div class=\"faq-card\">\n<h3>How long does CE marking take for a medical device?<\/h3>\n<p>For Class I devices (self-certification), the process takes 1\u20133 months if documentation is ready. For Class IIa, expect 8\u201314 months including Notified Body review. For Class IIb and III, the timeline extends to 12\u201324 months. The longest delay is typically the Notified Body queue, which can add 6\u201318 months to the process.<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>How much does CE marking cost for medical devices?<\/h3>\n<p>Total costs include testing (\u20ac5,000\u201350,000 depending on device complexity), Notified Body fees (\u20ac15,000\u201360,000 for initial certification), Authorized Representative fees (\u20ac3,000\u201310,000 annually), and internal documentation preparation. For a Class IIa surgical device, total first-year costs typically range from \u20ac30,000\u201380,000.<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>Can a non-EU manufacturer apply for CE marking directly?<\/h3>\n<p>No. Non-EU manufacturers must appoint an EU Authorized Representative who acts as the regulatory liaison. The manufacturer cannot submit directly to a Notified Body without an AR in place. The AR must be named on the CE certificate and in the EUDAMED registration.<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>Is CE marking valid in all countries?<\/h3>\n<p>CE marking is recognized in EU member states and EEA countries (Norway, Iceland, Liechtenstein). It is not automatically accepted in other markets \u2014 the US requires FDA clearance, the UK requires UKCA marking (post-Brexit), and other countries have their own regulatory pathways. But CE marking is often accepted as supporting evidence in markets that recognize EU standards.<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>What happens if my medical device has CE marking but fails a market surveillance check?<\/h3>\n<p>The competent authority can issue a corrective action request, require product recall, or suspend the CE certificate. The manufacturer must investigate the non-conformity, implement corrective actions, and demonstrate compliance before the device can return to market. The <a href=\"https:\/\/health.ec.europa.eu\/medical-devices-sector\/new-regulations\/guidance-mdcg-endorsed-documents-and-other-guidance_en\" rel=\"noopener\" target=\"_blank\">MDCG endorsed guidance documents<\/a> provide parallel guidance for EU market surveillance and field safety corrective action reporting.<\/p>\n<\/div>\n<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How long does CE marking take for a medical device?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"For Class I devices (self-certification), the process takes 1\u20133 months if documentation is ready. For Class IIa, expect 8\u201314 months including Notified Body review. For Class IIb and III, the timeline extends to 12\u201324 months. 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The manufacturer must investigate the non-conformity, implement corrective actions, and demonstrate compliance before the device can return to market.\"\n      }\n    }\n  ]\n}\n<\/script><\/p>\n<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"Article\",\n  \"name\": \"CE Marking Step by Step for Imported Medical Devices\",\n  \"description\": \"Complete step-by-step guide to CE marking for imported medical devices under EU MDR 2017\/745. Covers device classification, technical documentation, Notified Body engagement, conformity assessment, and post-market obligations.\",\n  \"author\": {\n    \"@type\": \"Organization\",\n    \"name\": \"Sanyang Medical\"\n  },\n  \"publisher\": {\n    \"@type\": \"Organization\",\n    \"name\": \"Sanyang Medical\"\n  },\n  \"datePublished\": \"2026-08-10\",\n  \"dateModified\": \"2026-08-10\",\n  \"mainEntityOfPage\": {\n    \"@type\": \"WebPage\",\n    \"@id\": \"https:\/\/sanyangmedical.com\/ce-marking-medical-device-step-by-step\/\"\n  }\n}\n<\/script><\/p>\n<p><script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"GeoCoordinates\",\n  \"name\": \"Sanyang Medical Equipment\",\n  \"description\": \"CE marking process for medical devices under EU MDR 2017\/745: 7 steps from device classification (Class I\/IIa\/IIb\/III) through technical documentation, Notified Body engagement, conformity assessment, EU Declaration of Conformity, EUDAMED registration, and post-market surveillance.\"\n}\n<\/script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Importing medical devices into the European Union requires CE marking \u2014 a conformity mark that signals the product meets the EU Medical Device Regulation (MDR 2017\/745). For manufacturers and distributors outside Europe, the CE marking process involves multiple steps, specific documentation, and engagement with a Notified Body. Getting it wrong means customs rejection, market withdrawal, &#8230; <a title=\"CE Marking Step by Step for Imported Medical Devices\" class=\"read-more\" href=\"https:\/\/sanyangmedical.com\/fr\/ce-marking-medical-device-step-by-step\/\" aria-label=\"En savoir plus sur CE Marking Step by Step for Imported Medical Devices\">Lire la suite<\/a><\/p>","protected":false},"author":1,"featured_media":3256,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rank_math_title":"CE Marking Step by Step for Medical Devices | EU MDR Guide","rank_math_description":"Complete 7-step guide to CE marking for imported medical devices under EU MDR 2017\/745. 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