Staying on top of global Unique Device Identification (UDI) regulatory compliance can improve outcomes for both patients and medical device manufacturers

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, as digitization continues to play an increasing and positive role in healthcare, medical device software and regulated software as a medical device (SaMD) is required to carry unique device identification too. 

Each UDI linked to the FDA’s Global Unique Device Identification Database (GUDID), 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’s evolution. Both databases function as a registration and notification system, but only GUDID is open to the public to reference currently, and EUDAMED aims for full implementation by 2025. 

While medical device 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’s 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.

In fact, Jay Crowley, a recognized expert on UDI, acknowledges this in his presentation, UDI 2.0 What have we learned – and where are we going, and even quotes Machiavelli in support of medical device inventors and the challenges of compliance:

‘Nothing 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.’  – Niccolo Machiavelli (1523)

Benefits for Medical Device Manufacturers

In taking on the challenge of staying on top of compliance and regulatory requirements, medical device manufacturers are not just pleasing the EU’s Medical Device (MDR) regulation and FDA’s UDI regulation and 21 CFR Part 803, medical device manufacturers themselves also benefit. They are able to:

• Better manage recalls
• More easily distinguish between device versions, sizes and other characteristics
• Track devices from different production facilities
• Collect accurate data for post-market surveillance
• Increase efficiency in their supply chain management.

UDIs can also make it more difficult for counterfeit devices to enter the market and threaten the sale of legitimate, regulatory-compliant devices.

As recalls of medical devices, medical devices with faulty software, pharmaceuticals and nutraceuticals continue, the Universal Device Identification’s ability to facilitate post-market surveillance has remained an asset for manufacturers, clinicians, and patients since the launch of the UDI regulations.

Universal Device Identification in the US & Europe: The Same But Very Different

The UDI was introduced by the FDA in 2013 but was not introduced by EUDAMED in Europe until 2017. 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. 

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. 

As previously mentioned, UDIs can be extremely helpful to medical device manufacturers for conducting post-market surveillance (PMS). 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 “post-market clinical follow-up (PMCF)”, and unlike the US, it’s required for all medical devices, and justification is required for not conducting it.

In summary, the core UDI requirements are quite similar but the EU system is more comprehensive.

UDI Creates Opportunities to Sell Outside the US and Europe 

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.

Reminder Regarding Devices Labeled Before and After September 2023: Full Compliance with UDI Requirements is Now Mandatory

For every manufacturer involved in a device’s lifecycle, there are guidelines set forth by the FDA in reference to September 2023. 

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 September 2023. Devices labeled on or after September 24, 2023 must comply with all applicable UDI requirements. Full compliance 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.

Also, medical device manufacturers should remember that 21 CFR 830.330 (b) requires manufacturers to maintain updated information in GUDID for the life of the device. 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 ‘Device Description,’ and commercial distribution end date.

Global UDI Challenges will Continue for Medical Device Manufacturers

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:

1. Diverse Regulatory Landscape: Different countries and regions have distinct regulatory frameworks and timelines for UDI adoption. Manufacturers must navigate a complex web of regulations, each with its unique requirements, documentation, and compliance deadlines which is time-consuming and requires a lot of resources.
2. Integration with Existing Systems: Implementing a standardized UDI system usually requires significant adjustments to existing processes, labeling systems and databases. Integrating UDI into the manufacturing and distribution workflow can be challenging, especially for manufacturers operating on legacy systems.
3. Interoperability Among Different Systems: Across the supply chain this can be challenging. UDI data needs to be seamlessly shared between manufacturers, regulatory authorities, healthcare providers, and distributors for it to work as intended and needs to follow standardized data formats and protocols.
4. Global Supply Chain Complexity: Many device manufacturers operate on a global scale with intricate supply chains involving multiple suppliers, contract manufacturers, and distributors. Small and medium-sized manufacturers may face budgetary issues, so it’s harder to invest in the necessary technology and processes required for compliance.
5. Timeline Pressures: Regulatory agencies set specific deadlines for UDI compliance, and manufacturers may face challenges in meeting these timelines. It’s important to remain abreast of the timelines, regulatory changes, and be prepared to overhaul existing processes and systems within a limited timeframe. Operational disruptions and potential delays in product releases can occur without proper planning.
6. Legacy Device Challenges: For manufacturers with an extensive portfolio of existing devices, ensuring UDI compliance for legacy products can be a formidable task. Retrofitting UDI onto older devices may require redesigning labels, updating databases, and managing regulatory submissions for products that were not initially designed with UDI in mind.
7. Global Harmonization Efforts: While efforts are underway to harmonize UDI requirements globally, achieving true global alignment remains a work in progress. Manufacturers must stay abreast of evolving regulations in different regions and be agile in adapting their UDI strategies to align with changing global standards.

From Concept to the Marketplace: Checklist of  Considerations to Ensure UDI Compliance

While a UDI system is intended to capture and maintain information related to the identification and attributes of medical devices, that’s 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 supplier management.

For instance, a 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’s full implementation in a couple of years.

Therefore, the successful journey of a product being fully compliant in the global marketplace can be made more manageable by considering following:

• Automated Data Collection: Competent aggregation of UDI attribute data from various sources within the enterprise. This includes information about the device identifier, production identifier, and other relevant attributes. Should also be capable of maintaining a single and secure system of record for regulatory submissions. This is critically important given that data provided to the GUDID should be consistent with data provided to regulatory agencies for other purposes such as recalls.
  
• Enforce Access Control: Preserve data integrity and manage changes throughout the product life cycle while automating review and approval workflows.
• Manage FDA GUDID Transactions: Ensure capability to record verification, accurate submission and confirmation while automatically triggering approval workflows when regulatory submission requirements need to be updated, along with a secure audit trail of every transaction.
• Integrate Serialization and Data Collection Capabilities: Efficiency in inventory tracking and enhanced label printing for the creation of regulatory compliant labels.
• Capability to Easily Incorporate Future Change: For example, if a manufacturer has a product sold at retail, the US Sunrise 2027 initiative to accept 2D barcodes at point-of-sale, the manufacturer may have to make some changes to labeling to accommodate a retail pharmacy or other retail distributor as one example.

The Cost of Non-Compliance is Greater than Compliance

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.

QAD’s Proven Track Record

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.

Quality and Traceability as Standard in QAD Solutions

QAD integrates quality into core life sciences manufacturing processes, which provides manufacturers with quality management automation and analytics features, including item data attributes for enhanced quality control. In addition, QAD EQMS 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. 

QAD traceability and serialization functionality helps companies comply with regulations for UDI and the DSCSA (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.

QAD Adaptive ERP Designed to Meet the Challenges of Today and Provide Flexibility for Tomorrow’s Demands

Designed to ensure better outcomes for medical device manufacturers and ultimately patients, QAD Adaptive ERP enables medical device manufacturers to: 

• Deploy a full-featured, cloud-enabled ERP solution that is available on an FDA “Qualified” and auditable infrastructure 
• Optimize processes across life sciences manufacturing, the supply chain and customer facing operations, with an emphasis on quality, cost and delivery while achieving operational excellence 
• Support global growth and expansion 
• Access and analyze processes and data, with visibility to fine-tune operations and make rapid, fact-based business decisions 
• Operate sites simultaneously with a single view of transactions and information across all business entities 
• More rapidly meet ever-evolving compliance requirements

Visit our website to see specific ways QAD has helped life science manufacturers solve their most pressing concerns today and set them up for success with tomorrow’s inevitable uncertainties.