Unique Device Identification Made Simple with V-Reg Solutions
How V-Reg Solutions Can Support Manufacturers Implement UDI (Unique Device Identification)
As global regulatory bodies continue to tighten traceability and post-market surveillance requirements for medical devices, the Unique Device Identification (UDI) system has become a critical part of regulatory compliance. For manufacturers, implementing UDI can be a complex, multi-step process that involves data structuring, submission to designated agencies, and integration into their quality management systems. This is where V-Reg Solutions —a regulatory data and compliance management platform—can significantly streamline and support the UDI implementation process.
What is UDI and Why is it Important?
Unique Device Identification (UDI) is a system used to mark and identify medical devices. It improves patient safety, enables better traceability, facilitates recalls, supports post-market surveillance, and enhances inventory management. A UDI consists of:
- Device Identifier (DI): Static information about the manufacturer and the model of the device.
- Production Identifier (PI): Dynamic information like lot number, serial number, manufacturing or expiration date. Governments and regulators such as the U.S. FDA, European Commission, and Health Canada mandate UDI implementation as part of their medical device regulations.
Challenges in UDI Implementation
Many manufacturers, especially small and medium-sized enterprises (SMEs), struggle with:
- Understanding regional requirements – Navigating differing UDI rules across global markets.
- Choosing the issuing agency – Selecting the right agency suitable for their product scope.
- Managing product complexity – Handling UDI for ~100 products and variants.
- Limited IT resources – No dedicated budget for complex software solutions.
- Data submission hurdles – Difficulty uploading data to systems like EUDAMED.
- System integration – Incorporating UDI into labelling, packaging, ERP, and QMS.
- Regulatory pressure – Short timelines to comply with MDR requirements.
This is where V-Reg Solutions comes into play.
How V-Reg Solutions Supports UDI Implementation
V-Reg Solutions is a regulatory consultancy designed to help medical device manufacturers comply with global regulatory requirements—including UDI. Here's how it can help:
1. Structured UDI Data Collection
V-Reg Solutions helps manufacturers to capture UDI data in the correct structure as per issuing agency and regulatory authority requirements. These include:
- Device description
- Risk class
- Intended use
- Sterilization information (If Applicable)
- Storage and handling
- Packaging levels
2. Multi-Region Regulatory Support
Different regions have different UDI requirements. V-Reg Solutions helps manufacturers configure UDI data as per specific regulatory authority standards.
3. UDI Issuing Agency Integration
V-Reg Solutions helps manufacturers choose the right agency and format (e.g., GTIN from GS1) based on their product type and market destination.
4. UDI Labelling and Packaging Guidance
V-Reg Solutions offers guidance for placing UDI barcodes (1D/2D) or RFID tags on device labels and packaging, depending on class, packaging level, and regional requirements.
5. Post-Market Updates and Lifecycle Management
UDI doesn’t stop at initial submission. Manufacturers may need to update data due to device changes or regulatory revisions. V-Reg Solutions tracks version history, manages DI re-use rules, and facilitates withdrawal or delisting of devices.
Conclusion
Implementing UDI is not just about placing a barcode on a label—it’s about building a robust, traceable, and compliant data around each medical device. For manufacturers navigating the intricacies of global regulations, V-Reg Solutions offers a comprehensive solution that simplifies and streamlines UDI management. Whether you are launching a new device or preparing for EU MDR compliance, V-Reg Solutions ensures your UDI strategy is accurate, efficient, and audit-ready.
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Contact Us: info@vregsolutions.com
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Website: https://www.vregsolutions.com/
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Location: B-115, Super Arcade, Near Science City, Hare Krishna Temple Road, Bhadaj, Santej, Tal. Kalol, Dist. Gandhinagar - 382721, Gujarat
