Case Study: Successful Implementation of UDI Data Management at a Leading Dental Products Manufacturer

About the Company

A mid-sized dental product manufacturer headquartered in Germany develops and produces a wide range of dental implant systems, surgical instruments, and digital planning solutions for modern dentistry. With a product portfolio of more than 1,200 items, the company operates globally and distributes its products in over 35 countries worldwide.

The Challenge

As a globally active company in the medical technology sector, the manufacturer faced the complex challenge of meeting the diverse Unique Device Identification (UDI) requirements of various regulatory authorities:

  • Extensive product portfolio: Management of over 1,200 UDI-relevant products
  • Time-consuming manual processes: Manual data entry into EUDAMED required 10–15 minutes per UDI record for experienced personnel, even longer in case of errors
  • Global compliance requirements: Simultaneous fulfillment of FDA (USA), EUDAMED (EU), and other international regulations
  • Data quality and consistency: Ensuring up-to-date and consistent product-related data across multiple systems
  • Decentralized organizational structure: Coordination between product management, regulatory affairs, and quality assurance across various locations
  • Existing SAP system: The need for seamless integration into the current IT infrastructure

The Head of Regulatory Affairs described the situation: “With more than 1,000 products, manual data entry into EUDAMED alone would have taken over 250 working hours – not including corrections and updates. Given our international focus, we had to manage multiple UDI systems simultaneously – a challenge that our previous processes could hardly meet.”

The Solution: Global UDI SAP Add-On

Following a comprehensive market analysis, the company chose the Global UDI SAP Add-On solution from Europe IT Consulting. The decision was driven by the following key product features:

Global UDI SAP Add-On: Core Features

  • Multi-regulatory support: Simultaneous management of FDA, EUDAMED, and other authority standards with specific validations
  • Seamless SAP integration: Direct connection to existing SAP modules without data redundancy
  • Excel bulk import: Time-saving handling of large datasets using specialized import templates
  • Validated 3-step workflow: Automated approval processes with complete documentation
  • Direct authority interfaces: AS2/AS4 connectors for direct, secure communication with authorities

Implementation Phases

Phase 1: Requirements Analysis and System Setup

  • Detailed gap analysis of existing processes
  • Configuration of the SAP Add-On with a focus on FDA and EUDAMED as primary authorities
  • Setup of business units according to product categories (implants, instruments, digital solutions)

Europe IT Consulting supported this phase with a two-day onsite workshop, during which the company’s specific requirements were analyzed and a customized implementation plan developed. The experienced consulting team conducted in-depth interviews with all relevant stakeholders to ensure that all regulatory and operational needs were addressed.

Phase 2: Data Migration and Quality Assurance

  • Import of existing product data using Excel templates
  • Validation and cleansing of records
  • Establishment of a central UDI database with complete traceability

Phase 3: Workflow Implementation and Training

  • Setup of a three-stage approval workflow with clearly defined responsibilities
  • Comprehensive training of staff from product management, regulatory affairs, and quality assurance
  • Testing phase with realistic data examples for all involved departments

The intensive support provided by Europe IT Consulting throughout the entire project was a key success factor. The dedicated project team was available for both technical and regulatory questions, helping to optimize UDI processes and establish best practices. Weekly project steering meetings with the consultants allowed for agile adjustments to the implementation plan as challenges arose.

Phase 4: Authority Connection and Go-Live

  • Gradual go-live with selected product groups
  • AS4 /AS2 data submission service of Europe IT to EUDAMED and FDA GUDID

Results and Benefits

Time Savings and Efficiency Gains

  • Reduction in UDI data maintenance time from 10–15 minutes per record to an average of 2 minutes through optimized input screens and data reuse
  • Savings of over 200 working hours during the initial EUDAMED data submission
  • Reduction in processing time for regulatory updates from an average of 3 days to 4 hours
  • Acceleration of the approval process by 65% through automated workflows

Quality Improvement and Compliance

  • Error rate in data submission reduced from 12% to under 1%
  • 100% compliance rate during regulatory audits since implementation
  • Complete documentation of all changes and approvals through the integrated audit trail system

Business Advantages

  • Faster market entry of new products due to optimized regulatory processes
  • Simplified internationalization through parallel handling of different country requirements
  • Cost savings by avoiding compliance violations and associated penalties
  • Reduction in personnel requirements for UDI-related tasks despite increasing regulatory demands

Stakeholder Statements

Head of Regulatory Affairs Department:
“The Global UDI solution has fundamentally changed the way we work. What used to be an extremely time-consuming process—taking 10–15 minutes per record—is now a streamlined operation. The ability to manage all regulatory requirements for different markets from a single system is particularly valuable. The ongoing support from Europe IT Consulting’s expert team was a critical success factor – from the first workshop to go-live and beyond.”

UDI Data Manager:
“As the person responsible for daily UDI data maintenance, I can confirm that the software has significantly simplified our lives. The Excel upload function was especially helpful during initial data migration, and the intuitive user interface allows us to easily manage even complex changes across multiple products. The automatic validation checks give us the confidence that our data is correct before submission.”

Lessons Learned and Best Practices

The following best practices were derived from the project:

  1. Early involvement of all stakeholders: Engaging product management, regulatory affairs, and IT from the outset ensures all requirements are considered.
  2. Phased implementation: A step-by-step approach allows teams to gain experience and make adjustments before full-scale rollout.
  3. Comprehensive training: In-depth employee training is essential for acceptance and effective system use.
  4. Regular data quality checks: Both automated and manual reviews should be established to maintain high data quality over time.
  5. Clear responsibilities in the approval process: A defined workflow with transparent responsibilities prevents delays and confusion.
  6. Leverage expert knowledge: The combination of specialized software and experienced compliance consulting enables optimal adaptation to company-specific and regulatory needs.

Outlook

Following successful implementation, the company plans to expand the Global UDI solution with additional features:

  • Integration with the existing PLM system to avoid data redundancy
  • Implementation of a business intelligence module to analyze regulatory trends
  • Expansion to include additional authority modules for the Asian market (NMPA, PMDA)

“Thanks to the modular structure of the Global UDI SAP Add-On, we can flexibly respond to new requirements and continuously develop our UDI strategy,” emphasizes the Head of Regulatory Affairs. “The system grows with our needs and supports our global expansion strategy. We especially value the long-term support from Europe IT Consulting, which goes far beyond technical implementation and provides expert assistance with regulatory issues.”