{"id":8224,"date":"2024-01-12T19:02:42","date_gmt":"2024-01-12T19:02:42","guid":{"rendered":"https:\/\/www.orielstat.com\/blog\/?p=8224"},"modified":"2024-01-12T19:09:40","modified_gmt":"2024-01-12T19:09:40","slug":"understanding-fda-and-eu-medical-device-labeling-requirements","status":"publish","type":"post","link":"https:\/\/www.orielstat.com\/blog\/understanding-fda-and-eu-medical-device-labeling-requirements\/","title":{"rendered":"Understanding FDA and EU Medical Device Labeling Requirements"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"8224\" class=\"elementor elementor-8224\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-7388bb3 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"7388bb3\" data-element_type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4264d41\" data-id=\"4264d41\" data-element_type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<section class=\"elementor-section elementor-inner-section elementor-element elementor-element-d04a716 blog-details-page elementor-section-full_width elementor-section-height-default elementor-section-height-default\" data-id=\"d04a716\" data-element_type=\"section\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-66 elementor-top-column elementor-element elementor-element-e193c4d\" data-id=\"e193c4d\" data-element_type=\"column\" data-settings=\"{&quot;background_background&quot;:&quot;gradient&quot;}\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t\t\t<div class=\"elementor-element elementor-element-aa22ff3 elementor-widget elementor-widget-post-info\" data-id=\"aa22ff3\" data-element_type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/elementor\/css\/custom-widget-icon-list.min.css?ver=0\"><link rel=\"stylesheet\" href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/plugins\/elementor-pro\/assets\/css\/widget-theme-elements.min.css\">\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item-7f6be35 elementor-inline-item\" itemprop=\"datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/www.orielstat.com\/blog\/2024\/01\/12\/\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\tJanuary 12, 2024\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-25cfb2d elementor-widget elementor-widget-heading\" data-id=\"25cfb2d\" data-element_type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-heading-title{padding:0;margin:0;line-height:1}.elementor-widget-heading .elementor-heading-title[class*=elementor-size-]>a{color:inherit;font-size:inherit;line-height:inherit}.elementor-widget-heading .elementor-heading-title.elementor-size-small{font-size:15px}.elementor-widget-heading .elementor-heading-title.elementor-size-medium{font-size:19px}.elementor-widget-heading .elementor-heading-title.elementor-size-large{font-size:29px}.elementor-widget-heading .elementor-heading-title.elementor-size-xl{font-size:39px}.elementor-widget-heading .elementor-heading-title.elementor-size-xxl{font-size:59px}<\/style><h1 class=\"elementor-heading-title elementor-size-default\">Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols<\/h1>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-78a7c7e elementor-widget elementor-widget-image\" data-id=\"78a7c7e\" data-element_type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-image{text-align:center}.elementor-widget-image a{display:inline-block}.elementor-widget-image a img[src$=\".svg\"]{width:48px}.elementor-widget-image img{vertical-align:middle;display:inline-block}<\/style>\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" width=\"760\" height=\"508\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837.jpg\" class=\"attachment-full size-full wp-image-6276\" alt=\"\" loading=\"lazy\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837.jpg 760w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837-300x201.jpg 300w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837-500x334.jpg 500w\" sizes=\"(max-width: 760px) 100vw, 760px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-f7a5edb elementor-widget elementor-widget-text-editor\" data-id=\"f7a5edb\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t<style>\/*! elementor - v3.16.0 - 17-10-2023 *\/\n.elementor-widget-text-editor.elementor-drop-cap-view-stacked .elementor-drop-cap{background-color:#69727d;color:#fff}.elementor-widget-text-editor.elementor-drop-cap-view-framed .elementor-drop-cap{color:#69727d;border:3px solid;background-color:transparent}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap{margin-top:8px}.elementor-widget-text-editor:not(.elementor-drop-cap-view-default) .elementor-drop-cap-letter{width:1em;height:1em}.elementor-widget-text-editor .elementor-drop-cap{float:left;text-align:center;line-height:1;font-size:50px}.elementor-widget-text-editor .elementor-drop-cap-letter{display:inline-block}<\/style>\t\t\t\t<p>You\u2019re in the final stretch of your go-to-market plan and you\u2019re ready to label your finished medical device. Labeling is the easy part, right?<\/p><p><em>Not quite.<\/em><\/p><p>When it comes to medical devices, the term\u00a0<em>labeling<\/em>\u00a0encompasses much more than a sticker \u2013 it refers to a set of materials and information about your device that is crucial for patient safety and effective device use. Major regulatory bodies enforce specific requirements to ensure that medical device labeling meets certain standards. Compliance with these requirements is a legal obligation for medical device and IVD manufacturers as long as your device is on the market.<\/p><p>In this article, we\u2019ll give you a high-level understanding of what labeling is, explain terminology you should know, and discuss key FDA, EU, and international requirements.<\/p><h3>\u00a0<\/h3><h3>What Is Medical Device Labeling?<\/h3><p>First of all, let\u2019s establish what labeling is and what it isn\u2019t. Labeling is written, printed, or graphic matter affixed to or associated with a medical device that is related to its identification, technical description, or use. Below is a more detailed list of what is in the scope of labeling:<\/p><table><tbody><tr bgcolor=\"#336699\"><td width=\"50%\"><h5><span style=\"color: #ffffff;\">On or Accompanying the Device<\/span><\/h5><\/td><td><h5><span style=\"color: #ffffff;\">Promoting the Device<\/span><\/h5><\/td><\/tr><tr><td><ul><li>Symbols or words on the device itself<\/li><li>Instructions for use (IFU)<\/li><li>Maintenance or safety manuals<\/li><li>Packaging: pouch, box, or carton label<\/li><\/ul><\/td><td><ul><li>Web video tutorials or user training modules<\/li><li>Marketing materials, including social media posts, web pages, sales videos, and press releases<\/li><\/ul><\/td><\/tr><\/tbody><\/table><p>Any of the product\u2019s labeling materials can be scrutinized by regulators to ensure they comply with labeling requirements and guidance, whether they are printed or digital (i.e., e-labeling). Let\u2019s look at how two major regulatory frameworks \u2013 the US FDA and EU Medical Devices Regulation (EU MDR 2017\/745) \u2013 regulate device labels and labeling.<\/p><h3>\u00a0<\/h3><h3>Key Medical Device Labeling Regulations in the US and EU<\/h3><p>Title 21 of the Code of Federal Regulations is very prescriptive regarding medical device labeling. 21 CFR Part 801 covers every aspect of labeling, from unique device identification (UDI) to translations. 21 CFR Part 820 \u2013 Quality System Regulation, Section 820.120 outlines labeling controls and monitoring procedures as part of your quality management system (QMS).<\/p><p>In the EU MDR, labeling requirements are addressed in Annex 1, Chapter III \u2013 Requirements Regarding the Information Supplied with the Device, Section 23.<\/p><h3>\u00a0<\/h3><h3>Components of a Medical Device Label<\/h3><p>When you think about medical device labeling, the actual label on the device is probably the first thing that comes to mind. While the label is only one piece of the labeling puzzle, it is a critical piece to get right.<\/p><p>The term\u00a0<em>label\u00a0<\/em>refers to the written, printed, or graphic information appearing on the device itself, on the package of each unit, or on the packaging of multiple devices. The label can also include a marking, which is engraved or printed directly onto the product. As you\u2019ll see in the table below, US and EU label requirements are relatively consistent.<\/p><table><tbody><tr bgcolor=\"#336699\"><td><h5><span style=\"color: #ffffff;\">Label Requirement<\/span><\/h5><\/td><td width=\"208\"><h5><span style=\"color: #ffffff;\">US FDA<\/span><\/h5><\/td><td width=\"208\"><h5><span style=\"color: #ffffff;\">Europe<\/span><\/h5><\/td><\/tr><tr><td bgcolor=\"#add8e6\">Device identification: name, description, and \/ or intended use<\/td><td>Yes<\/td><td>Yes (CE Marking and Notified Body number are also required)<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Manufacturer identification: name and full address<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Lot number or serial number<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Unique Device Identifier (UDI)<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Manufacture or use-by date<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Name and address of in-country representative<\/td><td>Yes<\/td><td>Yes, for manufacturers outside the EU<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Substance warnings<\/td><td>Yes<\/td><td>If applicable<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Storage or handling instructions<\/td><td>Yes<\/td><td>If applicable<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Statement that product is a medical device<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Warnings or precautions<\/td><td>Yes<\/td><td>If applicable<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Indication that device is sterile, single-use, or custom-made<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><tr><td bgcolor=\"#add8e6\">Device measurements, quantities, etc.<\/td><td>Yes<\/td><td>Yes<\/td><\/tr><\/tbody><\/table><p>While many fundamental label requirements are the same, it\u2019s important to review US and EU requirements carefully to ensure that you comply, particularly if your product carries device-specific label requirements. Some discrepancies also exist between US and EU requirements for when to apply specific label exceptions.<\/p><h3>\u00a0<\/h3><h3>Unique Device Identifier (UDI) Requirements for Labeling in the US and EU<\/h3><p>UDI is \u201ca series of numeric or alphanumeric characters created through a globally accepted device identification and coding standard\u201d that allows the identification and traceability of a specific device [EU MDR Annex VI, Part C(1)]. Your device UDI must be created by an accredited issuing entity and registered in a country-specific database, such as GUDID in the US or EUDAMED in the EU.<\/p><p>UDI includes two parts:<\/p><ul><li><strong>Device identifier (UDI-DI)<\/strong>, which includes the company\u2019s identification number and the device version or model<\/li><li><strong>Production identifier (UDI-PI)<\/strong>, which provides access to information about the manufacture of that device, such as expiration date, lot or batch number, manufacturing site, etc.<\/li><\/ul><p>UDI also includes a UDI carrier, which comprises automatic identification and data capture (AIDC) technology, such as a barcode, and, if applicable, a human-readable interpretation (HRI). The UDI carrier should be placed on the device label or on the device itself, should be included on all levels of packaging, and must be readable during normal use and throughout the device\u2019s intended lifetime.<\/p><p><a href=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1.jpg\"><img decoding=\"async\" loading=\"lazy\" class=\"lazy loaded\" src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1-e1690296258130.jpg\" sizes=\"(max-width: 500px) 100vw, 500px\" srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1-e1690296258130.jpg 500w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1-e1690296258130-300x232.jpg 300w\" alt=\"\" width=\"500\" height=\"386\" data-src=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1-e1690296258130.jpg\" data-sizes=\"(max-width: 500px) 100vw, 500px\" data-srcset=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1-e1690296258130.jpg 500w, https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/udi-label-example_1-e1690296258130-300x232.jpg 300w\" data-was-processed=\"true\" \/><\/a><\/p><h6><em>Source:\u00a0<a href=\"https:\/\/www.fda.gov\/medical-devices\/unique-device-identification-system-udi-system\/udi-basics\" rel=\"nofollow\">https:\/\/www.fda.gov\/medical-devices\/unique-device-identification-system-udi-system\/udi-basics<\/a><\/em><\/h6><h3>\u00a0<\/h3><h3>Benefits of Using Symbols on Your Medical Device Label<\/h3><p>Symbols aren\u2019t required, but they can save valuable real estate on your device label, bypass language barriers, and reduce translation needs. FDA addresses the use of symbols in\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfCFR\/CFRSearch.cfm?fr=801.15\" rel=\"nofollow\">21 CFR Part 801.15<\/a>. In the EU,\u00a0<a href=\"https:\/\/www.iso.org\/standard\/77326.html\" rel=\"nofollow\">ISO 15223-1<\/a>\u00a0is the commonly used standard for compliance with the MDR. You can design your own symbols, but you will need to explain your custom symbols in accompanying text or a symbols glossary in the IFU, which is why most companies use internationally recognized symbols.<\/p><h3>\u00a0<\/h3><h3>What to Include in Your Medical Device Instructions for Use (IFU)<\/h3><p>As the name implies, your device\u2019s instructions for use explain everything the user needs to know about your device, including how and when to operate it. IFU can refer to a single, comprehensive document or several documents, including manuals, quick-start guides, online tutorials, and more. Your IFU should always include the following:<\/p><ul><li>Identity of the device and its manufacturer, including the device name or model number and description, as well as the manufacturer\u2019s name, address, and contact information<\/li><li>Intended use: indications, target groups, and users<\/li><li>Clinical performance and benefits<\/li><li>Information for safety: warnings, precautions, contraindications, residual risks, and side effects<\/li><li>Installation, preparation, operation, maintenance, and disposal instructions<\/li><li>Instructions for reporting incidents<\/li><li>Additional information for any device that is sterile, single-use, or involves radiation or hazardous substances<\/li><\/ul><p>It may be tempting to conserve space (and time) when preparing your IFU, especially if you\u2019re required to translate your IFU into multiple languages. Always prioritize clarity and attention to detail over brevity to ensure that your IFUs are accurate, thorough, and easy to understand. Well-written and organized IFUs are essential to preventing use errors and mitigating risk to patients or users.<\/p><p>\u00a0<\/p><table><tbody><tr><td><h5>Usability Considerations for the IFU<\/h5><p>Requirements aside, it\u2019s also important that you consider how your IFU will be used. Here are some tips:<\/p><ul><li>Write for the education and professional level of the intended user<\/li><li>Build human factors risk mitigation into instructions<\/li><li>Build usability study information into instructions<\/li><li>Supplement with photos, diagrams, and symbols<\/li><li>Use boldface text, notes, and warning text within procedural steps<\/li><li>Explore the strengths and weaknesses of the user interface design<\/li><li>Obtain objective evidence confirming that the user interface can be used safely<\/li><\/ul><\/td><\/tr><\/tbody><\/table><h3>\u00a0<\/h3><h3>Translation Requirements for Medical Device Labeling<\/h3><p>Translation requirements are a major point of difference between the US and EU. US FDA requires English-language labeling, with some exceptions. However, the EU MDR requires labeling translations to accommodate the official languages of the EU\u2019s 27 Member States, which could include 24 distinct languages. In general, all labeling must be translated, including:<\/p><ul><li>Label<\/li><li>Packaging<\/li><li>IFU<\/li><li>Software interfaces<\/li><li>Company website<\/li><\/ul><p>You will need controls in place to ensure that even minor labeling revisions are accurately reflected across all languages. Account for translation time when making any changes to labeling for your products distributed in the EU.<\/p><h3>\u00a0<\/h3><h3>Controlling Claims About Your Medical Device<\/h3><p>As far as regulators are concerned, any direct or implied assertion about your product, whether it\u2019s in an ad or a social media post \u2013 and whether it was made by someone at your company or not \u2013 can be considered a claim. Claims that \u201cmisbrand\u201d (FDA\u2019s term) or misrepresent your product can violate regulator guidelines and get your device taken off the market. Therefore, any claim about your device should be carefully crafted and monitored.<\/p><ul><li>Managing claims requires diligence, but it can be done as long as you have a system in place:<\/li><li>Arm your team with approved language they can use when writing ads or other promotional material.<\/li><li>Maintain an inventory of all device claims from product documentation, literature, and labeling in a claims database; ensure that all claims are substantiated.<\/li><li>Train your team on how and when (and where, if marketing internationally) to use social media to promote your product.<\/li><li>Implement a strategy for monitoring claims made outside your organization.<\/li><\/ul><h3>\u00a0<\/h3><h3>Ready to Learn More?<\/h3><p>Complying with device labeling requirements calls for meticulous attention to detail. If you\u2019re not sure where to start, our in-depth class on\u00a0<a href=\"https:\/\/www.orielstat.com\/courses\/medical-device-labeling-requirements-training\" target=\"_blank\" rel=\"nofollow noopener\">FDA and EU Medical Device Labeling Requirements<\/a>\u00a0will provide clarity on the path forward. 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Cause Analysis<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-27\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/clinical-evaluation-reports\/\">Clinical Evaluation Reports<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-59\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/combination-products\/\">Combination Products<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-23\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/complaint-handling-postmarket-surveillance\/\">Complaint Handling and PMS<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-33\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/design-control\/\">Design Control<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-34\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/in-vitro-diagnostics-ivdr\/\">EU IVDR (2017\/746)<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-16\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/eu-medical-device-regulation\/\">EU MDR (2017\/745)<\/a>\n<\/li>\n\t<li 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href=\"https:\/\/www.orielstat.com\/blog\/category\/labeling\/\">Labeling<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-18\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/mdsap\/\">MDSAP<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-58\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/pharmaceutical\/\">Pharmaceuticals<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-28\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qms-auditing\/\">QMS Auditing<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-72\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/qmsr\/\">QMSR<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-73\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/regulatory-compliance\/\">Regulatory Compliance<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-65\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software\/\">Software<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-63\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/software-cybersecurity\/\">Software and Cybersecurity<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-32\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/supplier-management\/\">Supplier Management<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-67\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/training\/\">Training<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-1\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/medical-device-ra-qa\/\">Uncategorized<\/a>\n<\/li>\n\t<li class=\"cat-item cat-item-35\"><a href=\"https:\/\/www.orielstat.com\/blog\/category\/validation\/\">Validation<\/a>\n<\/li>\n\t\t\t<\/ul>\n\n\t\t\t<\/section>\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols You\u2019re in the final stretch of your go-to-market plan and you\u2019re ready to label your finished medical device. Labeling is the easy part, right? Not quite. When it comes to medical devices, the term\u00a0labeling\u00a0encompasses much more than a sticker \u2013 it refers to [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6276,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_header_footer","format":"standard","meta":[],"categories":[66],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v21.7) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.orielstat.com\/blog\/understanding-fda-and-eu-medical-device-labeling-requirements\/\" \/>\r\n<meta property=\"og:locale\" content=\"en_US\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:description\" content=\"Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols You\u2019re in the final stretch of your go-to-market plan and you\u2019re ready to label your finished medical device. Labeling is the easy part, right? Not quite. When it comes to medical devices, the term\u00a0labeling\u00a0encompasses much more than a sticker \u2013 it refers to [&hellip;]\" \/>\r\n<meta property=\"og:url\" content=\"https:\/\/www.orielstat.com\/blog\/understanding-fda-and-eu-medical-device-labeling-requirements\/\" \/>\r\n<meta property=\"og:site_name\" content=\"Oriel STAT A MATRIX - ELIQUENT Life Sciences Blog\" \/>\r\n<meta property=\"article:published_time\" content=\"2024-01-12T19:02:42+00:00\" \/>\r\n<meta property=\"article:modified_time\" content=\"2024-01-12T19:09:40+00:00\" \/>\r\n<meta property=\"og:image\" content=\"https:\/\/www.orielstat.com\/blog\/wp-content\/uploads\/2023\/07\/two-persons-reviewing-labels-product-e1690296466837.jpg\" \/>\r\n\t<meta property=\"og:image:width\" content=\"760\" \/>\r\n\t<meta property=\"og:image:height\" content=\"508\" \/>\r\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\r\n<meta name=\"author\" content=\"usr192162\" \/>\r\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\r\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"usr192162\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\r\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Oriel STAT A MATRIX &#8211; ELIQUENT Life Sciences Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.orielstat.com\/blog\/understanding-fda-and-eu-medical-device-labeling-requirements\/","og_locale":"en_US","og_type":"article","og_description":"Medical Device Production, QMS and NPS Software Risk Assessment, Validation, and Protocols You\u2019re in the final stretch of your go-to-market plan and you\u2019re ready to label your finished medical device. 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