{"id":59895,"date":"2019-05-31T11:23:17","date_gmt":"2019-05-31T11:23:17","guid":{"rendered":"https:\/\/arca.bwy-demo.com\/medical-devices-serialization-and-traceability\/"},"modified":"2023-01-27T18:08:16","modified_gmt":"2023-01-27T17:08:16","slug":"medical-devices-serialization-and-traceability","status":"publish","type":"post","link":"https:\/\/www.arcalabelingmarking.com\/en\/medical-devices-serialization-and-traceability\/","title":{"rendered":"MEDICAL DEVICES SERIALIZATION AND TRACEABILITY"},"content":{"rendered":"<p>The international needs for patients\u2019 safety have led many countries to adopt some regulations for <strong>identifying<\/strong> the &#8220;<strong>Medical Devices<\/strong>&#8221; (contact lenses, bandages, scalpels, syringes, prosthesis, vitro diagnostic devices).<\/p>\n<p><strong>The UDI code (Unique Device Identifier) <\/strong>provides all the<strong> standardized information <\/strong>related to the life cycle of the device: from its production to its final use to prove its <strong>authenticity<\/strong>.<\/p>\n<p>USA (with the <strong>Food and Drug Administration<\/strong> <strong>FDA <\/strong>regulation) and UE (with the <strong>Medical Devices Regulation<\/strong> <strong>MDR 2017\/745<\/strong> and <strong>IVDR 2017\/746<\/strong> regulations) have approved regulations for the<strong> identification of medical devices <\/strong>while in Canada, Japan, China, Brazil, South Korea, China, Israel, Saudi Arabia and South Africa are about to be defined.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<p><strong>HOW TO SERIALIZE MEDICAL DEVICES<\/strong><\/p>\n<p>The producers must apply specific <strong>Unique Device Identifiers<\/strong> <strong>codes<\/strong> \u200b\u200bon all distributed medical devices. <strong>UDI<\/strong> is a unique numeric or alphanumeric code consisting of two parts:<\/p>\n<p>&#8211; <strong>Device ID<\/strong> (UDI-DI, Device Identifier). Identifies the specific version or model of the product (mandatory and fixed).<\/p>\n<p>&#8211; <strong>Production identification<\/strong> (UDI-PI, Production Identifier). It is variable and can contain one or more of the following information:<\/p>\n<ul>\n<li>Batch number<\/li>\n<li>Date of production<\/li>\n<li>Expiry date<\/li>\n<li>Serial number<\/li>\n<\/ul>\n<p>This information must be provided both in a human readable format (<strong>alphanumeric text<\/strong>) and in a format that can be read by machines using AIDC technology (<strong>Automatic Identification and Data Capture<\/strong>).<\/p>\n<p><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone size-full wp-image-82922\" src=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterSerializzazione-1.jpg\" alt=\"\" width=\"842\" height=\"613\" srcset=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterSerializzazione-1.jpg 842w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterSerializzazione-1-300x218.jpg 300w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterSerializzazione-1-768x559.jpg 768w\" sizes=\"(max-width: 842px) 100vw, 842px\" \/><\/p>\n<p>An <strong>UDI code<\/strong> must be placed on the primary packaging and at all upper levels of the device&#8217;s packaging. Since the <strong>GTIN (Global Trade Item Number<\/strong>, an <strong>identification number<\/strong> issued by <strong>GS1<\/strong>) is unique for each level of the device&#8217;s packaging, the UDI code is also unique to any level of the packaging.<\/p>\n<p>In fact, direct marking allows constant identification over time even when a device is no longer associated with the label or packaging.<\/p>\n<p>&nbsp;<\/p>\n<h3><strong>ARCA TECHNOLOGY FOR THE MARKING OF MEDICAL DEVICES<\/strong><\/h3>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-82930\" src=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-laser-01-1.jpg\" alt=\"\" width=\"960\" height=\"800\" srcset=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-laser-01-1.jpg 960w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-laser-01-1-300x250.jpg 300w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-laser-01-1-768x640.jpg 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/p>\n<p><strong>LASER MARKERS (UV, GREEN, FIBER, MOPA, CO2)<\/strong><br \/>\nThe <strong>ideal technology<\/strong> for direct marking on medical devices, indeed laser markers guarantees to:<br \/>\n&#8211; not damage the product preserving its integrity;<br \/>\n&#8211; etch high quality contents without defects, indelible and always readable;<br \/>\n&#8211; resist to highly alkaline, acid and corrosive cleaning processes.<\/p>\n<p><img decoding=\"async\" class=\"alignnone size-full wp-image-82926\" src=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-linerless-1.jpg\" alt=\"\" width=\"960\" height=\"800\" srcset=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-linerless-1.jpg 960w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-linerless-1-300x250.jpg 300w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/box-img-linerless-1-768x640.jpg 768w\" sizes=\"(max-width: 960px) 100vw, 960px\" \/><\/p>\n<p><strong>PRINT APPLY <\/strong><\/p>\n<p>The Ideal technology for printing UDI code in real time on a label and applying it on a product or a secondary packaging or a pallet allowing the code <strong>aggregation<\/strong> process (creation of the parent-child relationship between the unique codes of the unit packets and the UDI codes of the subsequent packaging levels) with the aim to obtain a better <strong>traceability <\/strong>of the medical devices.<\/p>\n<p><strong>CLASSIFICATION OF MEDICAL DEVICES<\/strong><\/p>\n<p>The classification of the medical device is based on the level of risk associated with the device under examination.<\/p>\n<ul>\n<li>Class III devices: cardiac catheters, coronary stents, heart valves, breast implants, HIV diagnostic tests, endosseous implants, artificial prostheses, long-term contact lenses, absorbable implantable materials for surgical sutures &#8230;<\/li>\n<li>Class II devices b: Pacemakers, automatic external defibrillators, acupuncture needles, infusion pumps &#8230;<\/li>\n<li>Class II devices a: Daily contact lenses, motorized wheelchairs, surgical drapes, dental materials, hearing aids, ultrasound diagnostic devices &#8230;<\/li>\n<li>Class I devices: Elastic bandages, latex gloves, portable and reusable surgical instruments.<\/li>\n<\/ul>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-83046\" src=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterArca-en-1.jpg\" alt=\"\" width=\"1500\" height=\"676\" srcset=\"https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterArca-en-1.jpg 1500w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterArca-en-1-300x135.jpg 300w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterArca-en-1-1024x461.jpg 1024w, https:\/\/www.arcalabelingmarking.com\/wp-content\/uploads\/NewsletterArca-en-1-768x346.jpg 768w\" sizes=\"(max-width: 1500px) 100vw, 1500px\" \/><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The international needs for patients\u2019 safety have led many countries to adopt some regulations for identifying the &#8220;Medical Devices&#8221; (contact lenses, bandages, scalpels, syringes, prosthesis, vitro diagnostic devices). The UDI code (Unique Device Identifier) provides all the standardized information related to the life cycle of the device: from its production to its final use to &#8230; <a title=\"MEDICAL DEVICES SERIALIZATION AND TRACEABILITY\" class=\"read-more\" href=\"https:\/\/www.arcalabelingmarking.com\/en\/medical-devices-serialization-and-traceability\/\" aria-label=\"Read more about MEDICAL DEVICES SERIALIZATION AND TRACEABILITY\">Read more<\/a><\/p>\n","protected":false},"author":3,"featured_media":60151,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[168,116],"tags":[],"class_list":["post-59895","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-focus","category-hot-topics"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v25.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Serialization and 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