Enterprise UDI Implementation Across 500+ Devices

Swiss MPC began with a detailed UDI readiness assessment across the client's entire product portfolio. We mapped every SKU against the applicable UDI requirements for each target market, identifying the specific Device Identifier (UDI-DI) and Production Identifier (UDI-PI) elements required. This analysis revealed that approximately 35% of existing labels required complete redesigns, while the remainder needed targeted modifications to incorporate UDI carriers (AIDC and HRI formats).

We developed a phased implementation plan aligned with the regulatory deadlines for each device class and market. Class III devices were prioritized first, followed by Class IIb, IIa, and Class I devices in subsequent waves. Each phase included label design, artwork verification, UDI database registration, and validation — structured to minimize disruption to manufacturing operations and supply chain logistics.

Our team worked directly with the client's IT department to integrate UDI data flows into their SAP ERP system and Windchill PLM environment. We designed data mapping schemas that ensured UDI-DI and UDI-PI data could be automatically generated, validated, and transmitted to EUDAMED and GUDID without manual re-entry. This integration eliminated the risk of transcription errors and established a sustainable, automated compliance workflow for future product launches.

For labeling compliance, we conducted a comprehensive review of all label artwork against EU MDR Annex I Chapter III, FDA 21 CFR Part 801, and ISO 15223-1 symbol requirements. Where direct marking was required for reusable surgical instruments, we worked with the client's manufacturing engineering teams to validate laser etching and electrochemical marking processes that maintained UDI readability through reprocessing cycles.

The project included extensive training for quality assurance, supply chain, and regulatory personnel across all four manufacturing sites. We developed site-specific SOPs for UDI label generation, verification, and database submission, ensuring consistent implementation regardless of location. Final validation included mock audits simulating both FDA and Notified Body UDI-focused inspections.