Whether a small business or a global medical device manufacturer: MDR and IVDR requirements raise similar questions for most companies. How can UDI data from different systems be reliably consolidated? What steps are necessary to prepare my data for EUDAMED? And which solutions support the submission of large UDI volumes to EUDAMED, swissdamed, or AusUDID?

The following real‑world, customer-inspired use cases offer insights into typical scenarios and decision-making processes. They show how different medical device manufacturers have addressed their individual challenges and established sustainable structures for their UDI processes.

Use Case 1: DesinfectOne – EUDAMED & Switzerland, Audit Preparation
Use Case 2: CrownMed Inc – Multiple Subsidiaries, Centralized Data Management Needed
Use Case 3: QuantumMedi – Multiple Companies Under One Contract, Scalable UDI Volumes Required
Use Case 4: MedaLegs GmbH – Very High UDI Volume

Do you face a similar situation – or something entirely different? We are happy to discuss your needs.

Possible Pitfalls

• Very short onboarding period before the audit

Solution & Support Provided with mytracekey Software

Software Solution: mytracekey UDI Manager FULL plus M2M, booked ahead of the audit to demonstrate a validated UDI process.

• Our support team closely guided the company, ensuring smooth and timely audit preparation.
• First data sets were successfully validated and transmitted to EUDAMED via M2M.
• All regulatory requirements were fully met.
• Quality Management was satisfied. They were able to integrate the process into their internal structures.
• Auditors were also pleased, thanks to full compliance with MDR requirements.

DesinfectOne about mytracekey UDI Manager

“Quality Management benefits greatly from data verification prior to upload and from the standardized process, helping them minimize risks.”

Possible Pitfalls

• Coordination and communication between subsidiaries
• Non-transparent software use as a regulatory risk
• Inefficient data entry

Solution & Support Provided with mytracekey Software

Software Solution: mytracekey UDI Manager ENTERPRISE

• All data can be managed within one tenant
• Each SRN has its own M2M connection to EUDAMED
• Different users and subsidiaries can enter and maintain data independently
• M2M significantly simplifies EUDAMED uploads
• The audit trail ensures traceability even with numerous users

CrownMed Inc. about the mytracekey UDI Manager

“We are pleased that tracekey provided the flexibility we needed. This enabled us to build a centralized master data management system for all subsidiaries, while keeping the solution user-friendly and easy to navigate.”

Possible Pitfalls

• Extensive alignment processes between the different companies
• Delays due to multiple onboarding processes

Solution & Support Provided with mytracekey Software

Software: One mytracekey UDI Manager account per company, each with M2M

• Initially, separate accounts with per‑company/SRN billing were independently booked via the webshop
• After several months, they switched to an ENTERPRISE contract for simplified billing and better cost overview
• All accounts and data remained intact
• M2M usage varied based on each company’s UDI requirements
• No user limit per tenant → ideal for large teams and inter-company collaboration

QuantumMedi about the mytracekey UDI Manager

“We were positively surprised by how user-friendly the software is. We could book our different tenants directly online and get started immediately. Looking back, the ENTERPRISE contract was the right decision: billing has become much simpler.”

Possible Pitfalls

• Different teams/people have varying levels of process understanding
• Unclear role responsibilities
• Pricing uncertainties due to changes and seasonal products

Solution & Support Provided with mytracekey Software

Software: mytracekey UDI Manager ENTERPRISE

• Process and onboarding workshop to align all teams: guidelines for software introduction and EUDAMED handling
• Best practices, explanation of roles, data collection, validation, and upload
• Clarification of tasks, organizational procedures, and workflows
• Transparent tiered pricing model agreed upon to accommodate seasonal variations and changes

MedaLegs GmbH about the UDI Manager

“Before speaking with tracekey, we were genuinely worried about how to efficiently and accurately register such a large number of UDIs in EUDAMED. With individual user trainings, workshops, and the user-friendly software, we were able to structure the process from the start with the necessary background knowledge and confidence.”

Manufacturers need a reliable software for their UDI Management

These use cases illustrate the wide range of starting points medical device companies face when implementing MDR/IVDR UDI requirements. Whether dealing with a few hundred or several hundred thousand UDIs, coordinating data across multiple locations, or preparing for an audit – each organization has its own structures, challenges, and priorities.

At the same time, the examples highlight three recurring success factors for UDI compliance:

1. Clear responsibilities
2. Reliable data quality
3. A system that fits the organizational framework

The experiences shared by these companies show that even complex requirements can be mastered when processes are transparent and both technical and organizational steps are aligned.

Regardless of company size or product portfolio, the path to UDI compliance is individual, and at the same time absolutely achievable. If you are facing similar challenges or a completely unique starting point, it is worth looking at proven approaches. We are happy to help you find the right solution for your situation.