Implementing Unique Device Identification (UDI) in Medical Devices
Dr. Vikas Ghattargi
Management Representative (MR) || Quality and Regulatory Affairs || Risk Management || Lead Auditor ISO13485 ISO 9001 || Medical device Quality Control || Lean Six Sigma Black Belt || Personal Trainer
The world of medical devices is complex, and Unique Device Identification (UDI) is now a must-have for compliance, patient safety, and product tracking. But how can you implement UDI in your organization effectively? Let’s break it down:
Q: What exactly is UDI, and why does it matter for my devices?
A: UDI stands for Unique Device Identification — a system that assigns a unique code to every medical device. It consists of two parts:
UDI ensures better traceability across the device lifecycle, helping improve patient safety, streamline regulatory compliance, and prevent counterfeiting.
Q: How do I get started with UDI?
A: Start by understanding your market requirements. Choose an issuing agency that fits your global distribution strategy, such as GS1, HIBCC, or ICCBBA. Once selected, assign unique DI and PI codes to each product and integrate these codes into your labels and packaging.
Q: How does UDI impact my Quality Management System (QMS)?
A: UDI must be integrated into your QMS. This means updating your processes for design control, complaint handling, and post-market surveillance. Every change in product or batch should be reflected in the UDI, ensuring full traceability throughout the product’s lifecycle.
Q: How do I apply UDI to labels and devices?
A: UDI must appear on both your product labels and in Human-Readable (HRI) and Automatic Identification and Data Capture (AIDC) formats, such as barcodes. For devices used multiple times (like surgical tools), the UDI might need to be directly marked on the device itself.
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Q: What are the benefits of UDI beyond compliance?
A: Implementing UDI isn’t just about ticking regulatory boxes. It helps improve:
Q: How do I stay compliant with different global regulations?
A: Each market has its own UDI requirements. For example, the FDA GUDID (U.S.) and EUDAMED (EU) databases have different data submission guidelines and timelines. It’s critical to stay up-to-date on each region’s regulations and ensure your system supports multi-market compliance.
Q: How can I maintain UDI data over time?
A: UDI is not a one-time task. Set up robust systems to maintain, update, and submit UDI data regularly, especially when launching new versions or making manufacturing changes. Make sure your UDI database is always up-to-date and aligned with regulatory requirements.
Ready to improve compliance, traceability, and safety with UDI? Let’s start a conversation about how you can successfully implement UDI in your workflow!
#UDI #MedicalDevices #Compliance #PatientSafety #QualityManagement #SupplyChain