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The U.S. Food and Drug Administration aims to enhance patient safety through the Universal Device Identification system, by way of improving the traceability of medical devices throughout their life cycle, to protect both patients and clinician users. Moreover, <\/span>as digitization continues to play an increasing and positive role in healthcare<\/span>, medical device software and regulated software as a medical device (SaMD) is required to carry unique device identification too.<\/span>\u00a0<\/span><\/p>\n Each UDI linked <\/span>to the FDA\u2019s <\/span>Global Unique Device Identification Database (GUDID),<\/span> enables the ability to track and trace the device should an adverse medical event occur or a device fails. Europe has a similar database called EUDAMED. However, the GUDID is fairly established, and by now, most manufacturers are aware of submission requirements, while EUDAMED is constantly evolving. For manufacturers desiring commercial release of their product in Europe, it is important to stay abreast of EUDAMED\u2019s evolution. Both databases function as <\/span>a registration and notification system, but only GUDID is open to the public to reference currently, and EUDAMED aims for full implementation by 2025.\u00a0<\/span><\/p>\n While <\/span>medical device<\/span><\/a> manufacturers recognize the need for rigorous requirements to ensure their devices perform safely and effectively for patients and clinicians, adherence to compliance is not without its own complexities. When a new device is successfully brought to market, it\u2019s a significant accomplishment but is also just the first step of many, as manufacturers try hard to stay on top of compliance and regulation requirements to trade confidently and compliantly.<\/span><\/p>\n In fact, Jay Crowley, a recognized expert on UDI, acknowledges this in his presentation, <\/span>UDI 2.0 What have we learned \u2013 and where are we going<\/span><\/a>, and even quotes Machiavelli in support of medical device inventors and the challenges of compliance:<\/span><\/p>\n \u2018Nothing is more difficult to undertake, more perilous to conduct or more uncertain in its outcome, than to take the lead in introducing a new order of things. For the innovator has for enemies all those who have done well under the old and lukewarm defenders amongst those who may do well under the new.\u2019<\/span><\/i>\u00a0 – Niccolo Machiavelli (1523)<\/span><\/p>\n In taking on the challenge of staying on top of compliance and regulatory requirements, medical device manufacturers are not just pleasing the EU\u2019s Medical Device (MDR) regulation and FDA\u2019s UDI regulation and 21 CFR Part 803, medical device manufacturers themselves <\/span>also benefit<\/span><\/a>. They are able to:<\/span><\/p>\n UDIs can also make it more difficult for counterfeit devices to enter the market and threaten the sale of legitimate, regulatory-compliant devices.<\/span><\/p>\n As recalls of <\/span>medical devices<\/span><\/a>, <\/span>medical devices with faulty software<\/span><\/a>, <\/span>pharmaceuticals and nutraceuticals<\/span><\/a> continue, the Universal Device Identification\u2019s ability to facilitate post-market surveillance has remained an asset for manufacturers, clinicians, and patients since the launch of the UDI regulations.<\/span><\/p>\n The UDI was introduced by the FDA in 2013 but was not introduced by EUDAMED in Europe until 2017. <\/span>While UDI in the US and Europe are similar in some ways, there are also stark contrasts. Both the US and Europe require UDIs to be placed on device labels and packages, and the UDIs should consist of a device identifier (DI) and production identifier like lot\/batch and serial number.<\/span>\u00a0<\/span><\/p>\n However, the European Union requires all medical devices of all risk classes to have a UDI, while the US exempts certain low-risk devices from the UDI requirement. The EU UDI system is projected to be implemented in 2025-2027, while the US UDI system has been fully implemented.\u00a0<\/span><\/p>\n As previously mentioned, UDIs can be extremely helpful to medical device manufacturers for conducting post-market surveillance (PMS). <\/span>The FDA requires device manufacturers to carry out PMS for Class II or Class III devices with certain criteria. Class I devices are typically exempt from post market surveillance requirements. In Europe, post-market surveillance is referred to as \u201cpost-market clinical follow-up (PMCF)\u201d, and unlike the US, it\u2019s required for all medical devices, and justification is required for not conducting it.<\/span><\/p>\n In summary, the core UDI requirements are quite similar but the EU system is more comprehensive.<\/span><\/p>\n While the vision of a globally harmonized UDI standard has not been achieved, meeting UDI standards has yet another benefit: there is a welcome invitation to trade from buyers outside the US and European markets. While countries outside of the US and EU may not have similar or strict regulatory guidelines in place, they favor medical device manufacturers who have followed FDA and EU MDR compliance because compliant devices have met rigorous standards and earned trust.<\/span><\/p>\n For every manufacturer involved in a device\u2019s lifecycle, there are guidelines set forth by the FDA in reference to September 2023.\u00a0<\/span><\/p>\n For stakeholders in the device industry, the FDA provided a reminder regarding the enforcement policies related to Use of National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers on device labels and packages which applies to devices labeled before <\/span>September 2023. <\/span>Devices labeled on or after September 24, 2023 must comply with all applicable UDI requirements.<\/span> Full compliance<\/span><\/a> with all applicable UDI requirements is now mandatory, which includes adhering to the prohibition on using specific legacy FDA identification National Drug Code (NDC) and National Health Related Item Code (NHRIC) numbers on the label.<\/span><\/p>\n Also, medical device manufacturers should remember that <\/span>21 CFR 830.330 (b)<\/span><\/a> requires manufacturers to <\/span>maintain updated information in GUDID for the life of the device<\/span><\/i>. This means anytime information originally submitted to the GUDID changes, the GUDID information must be updated accordingly. For example, if an item is no longer able to be ordered, then the date of order cessation must be updated \/ added in the GUDID. Lastly, in order for data elements critical for GUDID to be most useful to the manufacturer and the public, ensure that these fields are populated and accurate for all Device Identifier (DI) records: the catalog number, customer contact number, full and complete device \u2018Device Description,\u2019 and commercial distribution end date.<\/span><\/p>\n Challenges will always stem from the complex nature of the global market and its various regulatory environments, and the supply chains within the life sciences industry:<\/span><\/p>\n While a UDI system is intended to capture and maintain information related to the identification and attributes of medical devices, that\u2019s only part of the UDI journey needed to get a device to market. Medical device manufacturers must consider the impact of UDI compliance on other processes such as labeling and <\/span>supplier management<\/span><\/a>.<\/span><\/p>\n For instance, a <\/span>manufacturer may have to meet with their suppliers, and customers, who in turn may have their own packaging and labeling requirements. If a manufacturer distributes products in the US and EU, it would be wise to plan ahead and consider the impact of EUDAMED\u2019s full implementation in a couple of years.<\/span><\/p>\n Therefore, the successful journey of a product being fully compliant in the global marketplace can be made more manageable by considering following:<\/span><\/p>\n Although UDI compliance is a considerable expense, the cost of non-compliance could result in loss of business and reputation. Working closely with leading medical device manufacturers, QAD has developed comprehensive yet flexible solutions enabling manufacturers to effectively comply with the FDA UDI final rule.<\/span><\/p>\n With over 450 life sciences customers in 59 countries, QAD has a proven record of providing effective solutions for global medical device manufacturers and offers a full-featured, cloud solution available on an FDA-qualified and auditable infrastructure.<\/span><\/p>\n QAD integrates quality into core <\/span>life sciences manufacturing<\/span><\/a> processes, which provides manufacturers with quality management automation and analytics features, including item data attributes for enhanced quality control. In addition, <\/span>QAD EQMS<\/span><\/a> provides advanced quality management capabilities to support continuous improvement and post-market regulatory requirements including CAPA, Non Conformance Reporting, Complaints, and Audit support, integrating a complete quality management system into supply chain planning and execution.\u00a0<\/span><\/p>\n QAD traceability and serialization functionality helps companies comply with regulations for UDI and the <\/span>DSCSA<\/span><\/a> (Drug Supply Chain Security Act). In addition, the QAD Lot Trace Workbench enables companies to conduct effective product recalls and perform required recall effectiveness reporting to regulatory authorities, and have an internal and immediate view of inventory\/materials to support decisions regarding rework, scrapping, materials to be returned from suppliers and more.<\/span><\/p>\n Designed to ensure better outcomes for medical device manufacturers and ultimately patients, <\/span>QAD Adaptive ERP<\/span><\/a> enables medical device manufacturers to:\u00a0<\/span><\/p>\nBenefits for Medical Device Manufacturers<\/span><\/h2>\n
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Universal Device Identification in the US & Europe: <\/span>The Same But Very Different<\/span><\/h2>\n
UDI Creates Opportunities to Sell Outside the US and Europe\u00a0<\/span><\/h2>\n
Reminder Regarding Devices Labeled Before and After September 2023: Full Compliance with UDI Requirements is Now Mandatory<\/b><\/h3>\n
Global UDI Challenges will Continue for Medical Device Manufacturers<\/span><\/h2>\n
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From Concept to the Marketplace: Checklist of\u00a0 Considerations to Ensure UDI Compliance<\/span><\/h2>\n
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\n<\/span><\/i><\/li>\nThe Cost of Non-Compliance is Greater than Compliance<\/span><\/h2>\n
QAD\u2019s Proven Track Record<\/span><\/h2>\n
Quality and Traceability as Standard in QAD Solutions<\/span><\/h3>\n
QAD Adaptive ERP Designed to Meet the Challenges of <\/span>Today<\/span><\/i> and Provide Flexibility for Tomorrow\u2019s Demands<\/span><\/h3>\n