{"id":3682,"date":"2026-08-09T17:22:26","date_gmt":"2026-08-09T17:22:26","guid":{"rendered":"https:\/\/sanyangmedical.com\/eu-mdr-device-classification-class-i-iia-iib\/"},"modified":"2026-09-05T19:30:22","modified_gmt":"2026-09-05T19:30:22","slug":"eu-mdr-device-classification-class-i-iia-iib","status":"publish","type":"post","link":"https:\/\/sanyangmedical.com\/es\/eu-mdr-device-classification-class-i-iia-iib\/","title":{"rendered":"EU MDR Device Classification: Class I, IIa and IIb"},"content":{"rendered":"<p><!-- WP Post HTML --><br \/>\n<!-- Rank Math SEO --><br \/>\n<!-- Title: EU MDR Classification: Class I, IIa and IIb | Sanyang --><br \/>\n<!-- Slug: eu-mdr-device-classification-class-i-iia-iib --><br \/>\n<!-- Focus Keyword: EU MDR classification --><br \/>\n<!-- Meta Description: EU MDR classification explained: how Annex VIII rules assign Class I, IIa and IIb, where surgical lights and hospital beds land, and what importers must verify. --><br \/>\n<!-- Category: compliance-certifications --><\/p>\n<p>For how the same class maps to the GB route, see our <a href=\"https:\/\/sanyangmedical.com\/ukca-uk-mdr-2002-great-britain\/\">UKCA and UK MDR 2002 guide<\/a>.<\/p>\n<article class=\"sy-article\">\n<figure class=\"sy-article__featured\">\n    <img fetchpriority=\"high\" decoding=\"async\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-surgical-light-diamond-product-photo-hotel.jpg\" alt=\"Sanyang Medical Diamond LED surgical light, a Class I device under EU MDR classification\" width=\"1920\" height=\"1080\" loading=\"eager\" class=\"wp-image-1586\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-surgical-light-diamond-product-photo-hotel.jpg 1920w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-surgical-light-diamond-product-photo-hotel-300x169.jpg 300w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-surgical-light-diamond-product-photo-hotel-1024x576.jpg 1024w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-surgical-light-diamond-product-photo-hotel-768x432.jpg 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-surgical-light-diamond-product-photo-hotel-1536x864.jpg 1536w\" sizes=\"(max-width: 1920px) 100vw, 1920px\" \/><figcaption>An LED surgical light of the type that MDCG 2021-24 places in Class I under the EU MDR.<\/figcaption><\/figure>\n<div class=\"sy-article__body\">\n<p>EU MDR classification decides everything downstream: which conformity assessment route applies, whether a notified body is involved, what documentation the manufacturer must hold, and what an importer can demand before signing. The rules live in Article 51 and Annex VIII of Regulation (EU) 2017\/745, and the official example list sits in the Medical Device Coordination Group&#8217;s MDCG 2021-24 guidance. This article maps Class I, IIa and IIb for operating room equipment, shows you where surgical lights and hospital beds actually land, and lists the verification steps a buyer should run on every supplier claim.<\/p>\n<p>The classification system has four classes: I, IIa, IIb and III. Most operating room equipment that a hospital buys as furniture or infrastructure, surgical lights, operating tables, hospital beds, medical trolleys and pendants, sits in the lower half of that scale. The exceptions are where importers get into trouble: sterile versions, measuring functions and devices intended for diagnosis climb the ladder, and each climb changes the certificate package.<\/p>\n<p>This article is written from the buyer&#8217;s side of the table. The full legal text is in <a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/?uri=CELEX:32017R0745\" target=\"_blank\" rel=\"noopener\">Regulation (EU) 2017\/745<\/a>, and the example tables below come from the European Commission&#8217;s <a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2021-10\/mdcg_2021-24_en_0.pdf\" target=\"_blank\" rel=\"noopener\">MDCG 2021-24 guidance on classification<\/a>, which is the document to cite when a supplier&#8217;s class claim does not match yours.<\/p>\n<div class=\"yt-facade\" data-yt-id=\"ZVSlXv-v_YM\" role=\"button\" tabindex=\"0\" aria-label=\"Play video: What is European Medical Device Regulation (EU MDR) | Assent Inc.\" style=\"position:relative;width:100%;padding-bottom:56.25%;background:#000;border-radius:8px;margin:24px 0;cursor:pointer;overflow:hidden;\">\n<div style=\"position:absolute;top:0;left:0;width:100%;height:100%;display:flex;align-items:center;justify-content:center;\">\n    <svg width=\"68\" height=\"48\" viewBox=\"0 0 68 48\"><path d=\"M66.52 7.5c.78 2.94.78 15 0 17.94a8.5 8.5 0 01-6 6C57.58 32.22 34 32.22 34 32.22s-23.58 0-26.52-.78a8.5 8.5 0 01-6-6C.7 22.5.7 10.44 1.48 7.5a8.5 8.5 0 016-6C10.42.72 34 .72 34 .72s23.58 0 26.52.78a8.5 8.5 0 016 6z\" fill=\"red\"\/><path d=\"M45 24L27 14v20\" fill=\"white\"\/><\/svg>\n    <\/div>\n<\/p>\n<\/div>\n<p>    <script>\n    (function(){var f=document.querySelectorAll('.yt-facade');for(var i=0;i<f.length;i++){(function(el){el.addEventListener('click',function(){var id=el.getAttribute('data-yt-id');el.innerHTML='<iframe style=\"position:absolute;top:0;left:0;width:100%;height:100%\" src=\"https:\/\/www.youtube.com\/embed\/'+id+'?autoplay=1\" frameborder=\"0\" allow=\"autoplay;encrypted-media\" allowfullscreen><\/iframe>';});})(f[i]);}})();\n    <\/script><\/p>\n<h2>How MDR Classification Works<\/h2>\n<p>Classification is not a quality grade and it is not a market decision. It is a legal determination made by the manufacturer, applying the 22 rules in Annex VIII to the device&#8217;s intended purpose, its invasiveness, its duration of contact and its energy profile. The same physical product can land in different classes if the intended purpose is worded differently, which is why the wording on the label and in the Instructions for Use is part of the classification evidence.<\/p>\n<p>The rules group into four chapters: non-invasive devices, invasive devices, active devices and special rules. Active devices are where OR equipment mostly lives, and two rules matter more than the rest: the rule covering devices intended for diagnosis, which carries the illumination exception, and the fallback rule that classifies all other active devices as Class I. The MDCG guidance walks each rule with a worked example list, and the tables in this article use those examples verbatim.<\/p>\n<p>One structural point every importer should memorize: the class determines the conformity assessment annex in Article 52, and that annex determines whether a notified body appears in the certificate chain. A class that is claimed without a matching assessment route is a red flag, not a detail.<\/p>\n<h2>The Four Classes and What They Mean<\/h2>\n<p>The four classes form a risk ladder, and each rung adds obligations. Class I devices are non-invasive or low-risk active devices where the manufacturer self-declares conformity: it draws up the technical documentation, issues the EU Declaration of Conformity and affixes the CE mark without a notified body. The exceptions are the Class I sub-classes: sterile devices (Is), devices with a measuring function (Im) and reusable surgical instruments (Ir), where a notified body assesses that specific aspect.<\/p>\n<p>Class IIa and IIb devices go through notified body assessment under Annex IX or Annex XI, with technical documentation review, clinical evaluation and post-market surveillance reports (PSUR) required from Class IIa upward. Class III is the top rung, covering the highest-risk devices such as implants, with the strictest assessment and annual surveillance.<\/p>\n<table>\n<thead>\n<tr>\n<th>Class<\/th>\n<th>Conformity route<\/th>\n<th>MDCG examples<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<td>Class I<\/td>\n<td>Self-declaration, no notified body<\/td>\n<td>Surgical lamps, examination lamps, electric hospital beds<\/td>\n<\/tr>\n<tr>\n<td>Class IIa<\/td>\n<td>Notified body assessment<\/td>\n<td>Infusion cannulae, powered drills, dental handpieces<\/td>\n<\/tr>\n<tr>\n<td>Class IIb<\/td>\n<td>Notified body, clinical evaluation<\/td>\n<td>Surgical lasers, electrosurgical generators, ventilators<\/td>\n<\/tr>\n<tr>\n<td>Class III<\/td>\n<td>Strictest route, annual surveillance<\/td>\n<td>Joint replacements, spinal implants<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Read the table as a certificate checklist. A supplier quoting a Class IIa or IIb device must show you a notified body certificate with the four-digit notified body number. A supplier quoting Class I must show you the Declaration of Conformity, and if the device is sterile or measuring, a notified body statement for that aspect as well.<\/p>\n<h2>Where OR Equipment Actually Lands<\/h2>\n<p>The MDCG guidance settles the questions that float around operating room procurement. Surgical lamps are listed as Class I under the rule for devices intended for diagnosis, through the illumination exception: devices intended to illuminate the patient&#8217;s body in the visible spectrum, such as examination lamps and surgical lamps, are Class I. The guidance note defines illuminate as administering visible light for diagnosis, for example in visual electrophysiology, not merely casting light to improve visibility.<\/p>\n<p>That note is the whole game for lighting. A standard surgical light that casts light on the field is Class I and follows self-declaration. A light with an intended purpose that reaches into diagnosis, such as a device specified for visual electrophysiology screening, climbs to Class IIa because the intended purpose changed, not because the hardware changed. When a supplier upgrades a light&#8217;s brochure language, re-check the class claim.<\/p>\n<p>Electric hospital beds appear in the guidance as Class I under the fallback rule for all other active devices, alongside electric wheelchairs and dental patient chairs. The same logic applies to electric operating tables and most motorized OR furniture: Class I by default. The boundary moves when a function appears: a motorized ICU bed with integrated weighing scales carries a measuring function, which flags the Class Im aspect and pulls notified body involvement for that feature. The <a href=\"https:\/\/sanyangmedical.com\/ce-mdr-vs-fda-or-equipment-import\/\">CE MDR vs FDA for OR equipment<\/a> article compares this EU path against the US route for the same products.<\/p>\n<h2>Class I, IIa and IIb in Practice<\/h2>\n<p>For a Class I surgical light or operating table, the practical difference between a compliant and a non-compliant shipment is the documentation pack. The manufacturer must hold the technical documentation with the classification rule cited, the EU Declaration of Conformity referencing Regulation (EU) 2017\/745, the IEC 60601 test reports, and the label and IFU in the languages of the member states where the device is placed on the market. The <a href=\"https:\/\/sanyangmedical.com\/mdr-technical-documentation-eu-importers\/\">MDR technical documentation for EU importers<\/a> article lists the file structure line by line, and it is the companion piece to this EU MDR classification overview.<\/p>\n<p>For Class IIa and IIb, add the notified body certificate and the clinical evaluation summary. PSUR obligations start at Class IIa, so the manufacturer should be able to show the post-market surveillance plan as part of the file. UDI requirements apply across classes with staggered deadlines, and the importer registers as an economic operator in EUDAMED under its Article 13 obligations: verify the CE mark, check the DoC, confirm the labels and IFU, and keep the records for the authorities.<\/p>\n<p>None of this is optional for the buyer. The importer is legally responsible for verifying these elements before placing devices on the EU market, and customs and market surveillance authorities check exactly these documents. The factory&#8217;s certificate package is the importer&#8217;s compliance file, so it is worth auditing before the PO, not after the container arrives.<\/p>\n<figure>\n      <img decoding=\"async\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-delta-1536w.webp\" alt=\"Medical pendant production line with ceiling supply units in final assembly\" width=\"1536\" height=\"864\" loading=\"lazy\" class=\"wp-image-2606\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-delta-1536w.webp 1536w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-delta-1536w-300x169.webp 300w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-delta-1536w-1024x576.webp 1024w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-delta-1536w-768x432.webp 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-delta-1536w-18x10.webp 18w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><figcaption>Final assembly of ceiling supply units, where each device&#8217;s class and documentation set is fixed before export.<\/figcaption><\/figure>\n<h2>What Importers Must Verify<\/h2>\n<p>Run the class check as a five-point audit. First, the classification rule: the technical documentation must cite the specific Annex VIII rule that produces the claimed class, and the rule must match the device&#8217;s intended purpose. Second, the route: Class IIa and IIb require a notified body certificate; Class I requires a DoC, plus notified body involvement for Is, Im or Ir aspects. Third, the labels: CE mark, UDI carrier and the language requirements for your member state.<\/p>\n<p>Fourth, the certificate names: the DoC, the notified body certificate and the Free Sale Certificate must name the same manufacturer entity that appears on your contract, and the dates must cover the shipment window. Fifth, the sub-classes: a device sold as plain Class I that is delivered sterile, or that measures something clinically, is misclassified, and misclassification is a customs and liability problem, not a paperwork one.<\/p>\n<p>When the factory offers OEM or private-label production, the classification responsibility does not vanish: the legal manufacturer named on the device remains responsible for the classification and the conformity assessment, and your brand label sits on top of that legal entity. The <a href=\"https:\/\/sanyangmedical.com\/oem-odm-localization\/\">OEM\/ODM and localization services<\/a> page explains how the production and branding layers separate, and the <a href=\"https:\/\/sanyangmedical.com\/iso-13485-explained-standard-covers-buyers\/\">ISO 13485 explained<\/a> and <a href=\"https:\/\/sanyangmedical.com\/iso-13485-vs-iso-9001-which-certificates-matter\/\">ISO 13485 vs ISO 9001<\/a> guides cover the quality-system certificates that support the file.<\/p>\n<figure>\n      <img decoding=\"async\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel.png\" alt=\"Surgical light assembly and inspection line at Sanyang Medical factory\" width=\"2304\" height=\"1728\" loading=\"lazy\" class=\"wp-image-2237\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel.png 2304w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel-300x225.png 300w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel-1024x768.png 1024w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel-768x576.png 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel-1536x1152.png 1536w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/lamp-hotel-2048x1536.png 2048w\" sizes=\"auto, (max-width: 2304px) 100vw, 2304px\" \/><figcaption>The assembly and inspection line where each surgical light receives the serialized records behind its Declaration of Conformity.<\/figcaption><\/figure>\n<h2>Classification Mistakes That Delay Shipments<\/h2>\n<p>The most common mistakes follow a pattern, and each has a cost. Claiming Class I for a device that is actually IIa delays the shipment at the notified body stage, because the certificate does not exist. Carrying a measuring function without declaring the Im aspect produces the same delay at a different door. Copying the old class from a pre-MDR certificate without re-running the EU MDR classification against the new rules is the quiet one: the rules changed, and some devices moved up a class.<\/p>\n<p>Sterile versions are a frequent trap. The same trolley or accessory sold sterile moves from plain Class I to Class Is, and the sterile aspect needs notified body assessment even though the base device stays Class I. If your tender requires sterile packaging, confirm the Is handling in the quotation, because it changes both the certificate and the lead time.<\/p>\n<figure>\n      <img decoding=\"async\" src=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-golf-1536w.webp\" alt=\"Sanyang Medical pendant factory assembly and testing line\" width=\"1536\" height=\"2048\" loading=\"lazy\" class=\"wp-image-3076\" srcset=\"https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-golf-1536w.webp 1536w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-golf-1536w-225x300.webp 225w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-golf-1536w-768x1024.webp 768w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-golf-1536w-1152x1536.webp 1152w, https:\/\/sanyangmedical.com\/wp-content\/uploads\/2026\/07\/sanyang-medical-medical-pendant-factory-photo-golf-1536w-9x12.webp 9w\" sizes=\"auto, (max-width: 1536px) 100vw, 1536px\" \/><figcaption>Assembly and testing on the factory line, the stage where the classification statement and serialized records are matched to each unit.<\/figcaption><\/figure>\n<p>Systems and procedure packs carry their own rule under MDR Article 22, and accessories follow the class of the device they support unless they have their own intended purpose. A camera added to a surgical light for documentation does not change the light&#8217;s class by itself; a camera specified for diagnostic use does. The wording of the purchase order and the supplier&#8217;s IFU must agree on the intended purpose, or the classification argument starts at the border.<\/p>\n<h2>How to Confirm the Class Before You Order<\/h2>\n<p>Ask the factory for the class statement in writing before the PO, in the form of the classification rule cited in the technical documentation, not a one-line claim in a sales email. Request the Declaration of Conformity and, for anything above Class I, the notified body certificate with its four-digit number. Verify the entity names and dates against your contract, and keep the file for the importer&#8217;s records.<\/p>\n<p>For Sanyang Medical products, the certificate package covers CE marking, ISO 13485 and ISO 9001, with the Free Sale Certificate and Apostille for tender markets, and the sales team confirms the EU MDR classification statement per model in writing. Standard production runs 3 to 7 days and custom configurations 15 to 20 days, which leaves room to settle the classification documents inside the production window rather than at the port. Send the model list and your destination market, and we will return the class statement and certificate pack with the quotation.<\/p>\n<section class=\"sy-faq\">\n<h2>Frequently Asked Questions<\/h2>\n<div class=\"faq-card\">\n<h3>What are the EU MDR device classes?<\/h3>\n<p>Four classes: I, IIa, IIb and III. Class I devices follow manufacturer self-declaration, Class IIa and IIb require notified body assessment, and Class III covers the highest-risk devices with the strictest route.<\/p>\n<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>Is a surgical light Class I or Class IIa under the MDR?<\/h3>\n<p>A standard surgical lamp is Class I under the illumination exception in the diagnosis rule, per MDCG 2021-24. A light whose intended purpose reaches into diagnosis, such as visual electrophysiology screening, moves to Class IIa.<\/p>\n<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>Do Class I devices need a notified body?<\/h3>\n<p>Not for the base device. The sterile (Is), measuring (Im) and reusable surgical instrument (Ir) aspects do require notified body assessment, and a device sold as sterile always carries that extra step.<\/p>\n<\/p>\n<\/div>\n<div class=\"faq-card\">\n<h3>How is the MDR class of a device determined?<\/h3>\n<p>The manufacturer applies the 22 rules in Annex VIII to the device&#8217;s intended purpose, invasiveness, contact duration and energy profile. The MDCG 2021-24 guidance provides worked examples for each rule.<\/p>\n<\/p>\n<\/div>\n<\/section>\n<\/div>\n<\/article>\n<p><!-- FAQPage Schema --><br \/>\n<script type=\"application\/ld+json\">\n{\n  \"@context\": \"https:\/\/schema.org\",\n  \"@type\": \"FAQPage\",\n  \"mainEntity\": [\n    {\n      \"@type\": \"Question\",\n      \"name\": \"What are the EU MDR device classes?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Four classes: I, IIa, IIb and III. Class I devices follow manufacturer self-declaration, Class IIa and IIb require notified body assessment, and Class III covers the highest-risk devices with the strictest route.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Is a surgical light Class I or Class IIa under the MDR?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"A standard surgical lamp is Class I under the illumination exception in the diagnosis rule, per MDCG 2021-24. A light whose intended purpose reaches into diagnosis, such as visual electrophysiology screening, moves to Class IIa.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"Do Class I devices need a notified body?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"Not for the base device. The sterile (Is), measuring (Im) and reusable surgical instrument (Ir) aspects do require notified body assessment, and a device sold as sterile always carries that extra step.\"\n      }\n    },\n    {\n      \"@type\": \"Question\",\n      \"name\": \"How is the MDR class of a device determined?\",\n      \"acceptedAnswer\": {\n        \"@type\": \"Answer\",\n        \"text\": \"The manufacturer applies the 22 rules in Annex VIII to the device's intended purpose, invasiveness, contact duration and energy profile. The MDCG 2021-24 guidance provides worked examples for each rule.\"\n      }\n    }\n  ]\n}\n<\/script><\/p>\n<p><!-- GEO AI Block --><br \/>\n<script type=\"application\/ld+json\" id=\"evo301-geo-ai-block\">\n{\n  \"definition\": \"EU MDR classification is the process under Regulation (EU) 2017\/745 that assigns medical devices to Class I, IIa, IIb or III using the 22 rules in Annex VIII. The class determines the conformity assessment route, notified body involvement and the documentation an importer must verify.\",\n  \"data_statements\": [\n    \"MDCG 2021-24 lists surgical lamps and examination lamps as Class I under the illumination exception of the diagnosis rule.\",\n    \"Electric hospital beds are Class I under the fallback rule for all other active devices in MDCG 2021-24.\",\n    \"Class I devices follow manufacturer self-declaration, while Class IIa and IIb require notified body assessment.\",\n    \"Sterile (Is), measuring (Im) and reusable surgical instrument (Ir) aspects of Class I devices need notified body involvement.\",\n    \"Sanyang Medical ships standard production in 3 to 7 days, with 15 to 20 days for custom configurations.\"\n  ],\n  \"qa_concise\": [\n    {\n      \"q\": \"What are the four EU MDR classes?\",\n      \"a\": \"Class I, IIa, IIb and III, assigned by the rules in Annex VIII.\"\n    },\n    {\n      \"q\": \"Which class are surgical lamps under the MDR?\",\n      \"a\": \"Class I, per the illumination exception in MDCG 2021-24.\"\n    },\n    {\n      \"q\": \"Do Class IIa devices need a notified body?\",\n      \"a\": \"Yes, under Annex IX or Annex XI of Regulation (EU) 2017\/745.\"\n    },\n    {\n      \"q\": \"What changes a Class I device into a higher class?\",\n      \"a\": \"An intended purpose in diagnosis, a measuring function, or sterile supply.\"\n    }\n  ]\n}\n<\/script><\/p>\n","protected":false},"excerpt":{"rendered":"<p>For how the same class maps to the GB route, see our UKCA and UK MDR 2002 guide. An LED surgical light of the type that MDCG 2021-24 places in Class I under the EU MDR. EU MDR classification decides everything downstream: which conformity assessment route applies, whether a notified body is involved, what documentation &#8230; <a title=\"EU MDR Device Classification: Class I, IIa and IIb\" class=\"read-more\" href=\"https:\/\/sanyangmedical.com\/es\/eu-mdr-device-classification-class-i-iia-iib\/\" aria-label=\"Leer m\u00e1s sobre EU MDR Device Classification: Class I, IIa and IIb\">Leer m\u00e1s<\/a><\/p>","protected":false},"author":1,"featured_media":1586,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"rank_math_title":"EU MDR Classification: Class I, IIa and IIb | Sanyang","rank_math_description":"EU MDR classification explained: how Annex VIII rules assign Class I, IIa and IIb, where surgical lights and hospital beds land, and what importers must verify.","rank_math_focus_keyword":"EU MDR classification","rank_math_robots":"","rank_math_canonical_url":"","rank_math_facebook_title":"","rank_math_facebook_description":"","rank_math_twitter_title":"","rank_math_twitter_description":"","_yoast_wpseo_title":"","_yoast_wpseo_metadesc":"","_yoast_wpseo_focuskw":"","_yoast_wpseo_canonical":"","_yoast_wpseo_meta-robots-noindex":"","_yoast_wpseo_meta-robots-nofollow":"","_yoast_wpseo_opengraph-title":"","_yoast_wpseo_opengraph-description":"","_yoast_wpseo_twitter-title":"","_yoast_wpseo_twitter-description":"","_aioseo_title":"","_aioseo_description":"","_aioseo_keywords":"","_aioseo_robots_default":"","_aioseo_robots_noindex":"","_aioseo_og_title":"","_aioseo_og_description":"","_aioseo_twitter_title":"","_aioseo_twitter_description":"","aiosp_title":"","aiosp_description":"","aiosp_keywords":"","_seopress_titles_title":"","_seopress_titles_desc":"","_seopress_analysis_target_kw":"","_seopress_robots_canonical":"","_seopress_robots_index":"","_seopress_robots_follow":"","_seopress_social_fb_title":"","_seopress_social_fb_desc":"","_seopress_social_twitter_title":"","_seopress_social_twitter_desc":"","_genesis_title":"","_genesis_description":"","_genesis_canonical":"","_genesis_noindex":"","_genesis_nofollow":"","slim_seo":"","footnotes":""},"categories":[111],"tags":[],"class_list":["post-3682","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-compliance-certifications"],"_links":{"self":[{"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/posts\/3682","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/comments?post=3682"}],"version-history":[{"count":1,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/posts\/3682\/revisions"}],"predecessor-version":[{"id":3756,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/posts\/3682\/revisions\/3756"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/media\/1586"}],"wp:attachment":[{"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/media?parent=3682"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/categories?post=3682"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sanyangmedical.com\/es\/wp-json\/wp\/v2\/tags?post=3682"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}