Unique Device Identification (UDI) Requirements for Medical Devices

The Purpose of UDI

Through the enforcement of UDI, the FDA seeks to reduce the misidentification of medical devices in the field that frequently results from suppliers and hospitals renumbering devices post-production. Renumbering hinders clear communication about the medical device between customer and manufacturer. It complicates the critical transmission of both recalls out to the customer and adverse event reports back to the manufacturer. While seeking to positively impact patient safety by improving the traceability of adverse event reports and product recalls, the regulation also seeks to protect manufacturers’ IP from the damaging effects of counterfeiting.

The Challenge of UDI

In addition to requiring medical device manufacturers to provide UDI-compliant labeling, the new regulation presents them with the significant challenge of efficiently handling the vast amounts of data required for UDI-compliant submissions for each and every product, including unique product versions, variants, configurations, and packaging. These activities include:

• Gather, format, and submit UDI data electronically
• Ensure the timely and accurate review and approval of all UDI data
• Create new submissions for all product versions and variants
• Update submissions when products, product configurations, or product packages change
• Track FDA responses, including rejections and related audits
• Document UDI data at the time of submission, storing a “snapshot” for future audits
• Address any and all future changes to the regulation
• Comply with similar global UDI regulations coming soon from various regional markets

The Cost of UDI Compliance

Predictably, the cost of complying with this complex, far-reaching regulation will be significant. It will present a challenge to the personnel, budgets, resources, and infrastructure needed to gain compliance across all product offerings while maintaining that compliance in the face of ever-changing products and new global requirements. What’s more, the risks associated with noncompliance are severe: threatening a manufacturer’s ability to sell medical devices across state lines in the US.

The PTC UDI solution: Compliance without Complexity

To help its medical device customers meet these needs, PTC began partnering with the FDA and major medical device manufacturers as far back as 2011, when the regulation was first proposed. The purpose: to architect a software solution that would fulfill the regulatory requirements of UDI while reducing the complexity involved in complying with such a far-reaching new requirement.

As a result, the PTC UDI solution is the first preconfigured, out-of-the-box solution to help medical device companies meet the end-to-end needs of UDI submission as quickly and effectively as possible. It provides complete management and traceability of UDI data while retaining the flexibility needed to scale to future regulatory and product development changes.

The PTC UDI solution allows you to:

• Collect and Control key UDI data, aggregating it from multiple data stores and legacy systems while maintaining dynamic, change-controlled links to source data;
• Automate the submission process with out-of-the-box review and approval workflows, pre-submission data validation algorithms identical to those used by the FDA, data formatting for seamless electronic submission, and submission monitoring and reporting;
• Streamline the management of UDI data, both to accommodate product versions/variants and to meet the needs of future regulatory requirements from the FDA and other global agencies.

Built upon the proven, enterprise-class PTC Windchill architecture, the PTC UDI solution leverages powerful workflow, automation, and electronic gateway capabilities to form an integral part of a PLM and quality-related software suite. It can additionally be integrated with existing ERP, MDM, MES, PLM, and quality systems.

For more information, please contact a sales representative.