Case Study: Efficient UDI Management with Excel Template at an Innovative MedTech Startup

About the Company

An innovative MedTech startup based in Switzerland, specializing in minimally invasive diagnostic devices for cardiology, has established itself as a niche provider in the European medical technology market. Founded in 2017, the company currently employs 43 staff and distributes its focused product portfolio of around 80 product variants across 12 European countries.

The Challenge

As a manufacturer of medical devices, the company faced the task of meeting the UDI (Unique Device Identification) requirements of the EU Medical Device Regulation (MDR) within the given timeframe without allocating disproportionate resources:

  • Limited human resources: A single Regulatory Affairs Manager responsible for all regulatory requirements
  • No dedicated IT budget: No financial capacity for an extensive software solution
  • Lack of technical know-how: No internal capabilities for XML development or AS4 data transmission
  • Manageable product volume: Around 100 UDI-relevant products and variants
  • Tight regulatory deadline: Need for a fast solution to comply with MDR timelines
  • No SAP infrastructure: Use of a basic ERP system without extensibility

The Regulatory Affairs Manager described the situation: “As a small company with a manageable product portfolio, we didn’t need a complex enterprise solution, but we did need a structured, reliable process for UDI data collection and submission. Any incorrect or delayed entry in EUDAMED could have had significant consequences for our market access. What we really needed was not just a tool, but a competent partner to guide us through the complex regulatory process.”

The Solution: MDR/IVDR Excel Template and Data Submission Service with Personalized Consulting

After researching various options, the company opted for a pragmatic combination of the MDR/IVDR Excel Template and the Data Submission Service from Europe IT Consulting. A particularly valuable aspect was the comprehensive personal consulting that supported the entire process. This solution enabled cost-efficient and reliable UDI management in the following stages:

MDR/IVDR Excel Template & Service: Key Components

  • Validated Excel template: Preconfigured data fields with built-in validation rules based on EUDAMED specifications
  • Regulatory-compliant formatting: Automatic format checks for product codes, dates, and catalog values
  • Integrated help functions: Context-sensitive explanations of regulatory fields embedded within the template
  • Professional conversion service: Transformation of Excel data into authority-compliant XML format by specialists
  • Secure AS4 transmission: Guaranteed data delivery to EUDAMED through certified AS4 gateway infrastructure
  • Personal consulting: Dedicated advisor with in-depth regulatory knowledge throughout the entire process

Phase 1: In-Depth Consulting and Template Customization

  • Comprehensive 90-minute online consultation to clarify specific needs
  • Individual recommendations for optimal product data structuring
  • Delivery of the Excel template preconfigured for medical devices
  • Detailed guidance on template structure and editing principles

The consulting provided by Europe IT Consulting went far beyond a standard product introduction. As the Regulatory Affairs Manager noted: “Already during the first call, it became clear that we were dealing with real experts—not only technically competent but also deeply familiar with regulatory requirements. They asked targeted questions about our product setup and what needed to be considered.”

Phase 2: Data Collection and Validation with Ongoing Support

  • Systematic data entry using the validated Excel format
  • Regular follow-ups with the dedicated consultant at Europe IT Consulting
  • Use of integrated validation rules to ensure data quality
  • Resolution of open questions via a prioritized support channel

“The personal support and quick response time from Europe IT Consulting were critical—we always had someone who understood and collaborated with us,” said the Regulatory Affairs Manager. “Whenever I sent a question in the morning, I had a solid answer by the afternoon. For more complex topics, my advisor would even schedule a spontaneous video call to resolve the issue directly. This kind of commitment is invaluable when working under time pressure.”

The Regulatory Affairs Manager made full use of the template’s integrated help functions: “The context-sensitive explanations were extremely valuable for someone like me, managing UDI alone. I could look up exactly what was required for each field and in what format—without having to switch systems.”

Phase 3: Data Conversion and Submission with Expert Guidance

  • Submission of the completed Excel file to Europe IT Consulting
  • Proactive quality review by a regulatory expert before conversion
  • Identification and resolution of potential issues in advance
  • Professional conversion into authority-compliant XML format by Europe IT
  • Validation of XML structure against latest authority specifications by Europe IT
  • Secure transmission to EUDAMED via certified AS4 gateway by Europe IT
  • Delivery of detailed submission protocols and confirmations
  • Final review session with best practice recommendations for updates

One standout benefit was the proactive approach taken by the consulting team: “Before converting the data, our consultant reviewed the Excel file with a regulatory expert’s eye and identified two critical errors that would’ve led to rejection by EUDAMED. That level of quality control was worth its weight in gold.”

The entire process—from the initial consultation to the successful EUDAMED submission—was completed within three weeks, which was crucial for meeting regulatory deadlines.

Results and Benefits

Using the MDR/IVDR Excel Template in combination with the Data Submission Service and expert consulting yielded the following benefits:

Cost and Resource Efficiency

  • Approx. 85% cost savings compared to a full-scale software solution
  • Minimal training required thanks to intuitive Excel interface and built-in guidance
  • No IT infrastructure changes needed—entire process managed within standard office tools

Quality and Compliance via Expert Oversight

  • 0% error rate during initial EUDAMED submission due to multi-stage validation and expert review
  • 100% compliance with current MDR requirements
  • Complete traceability through detailed submission logs
  • Knowledge transfer thanks to ongoing regulatory consultation

Time Savings and Flexibility

  • Implementation time reduced from several months to three weeks
  • Flexible data updates without dependency on IT departments
  • Rapid adaptation to regulatory changes
  • Internal workload reduction through external expert support

Emotional Reassurance

  • Stress reduction through reliable expert support during critical stages
  • Trusted relationship with a dedicated advisor
  • Peace of mind through full regulatory compliance

Stakeholder Testimonials

Regulatory Affairs Manager:
“The MDR/IVDR Excel Template was the ideal solution for us. It offered the perfect balance between structure and flexibility. The built-in validation rules helped me avoid mistakes. The data submission service was particularly valuable—we lacked the know-how and infrastructure to handle XML conversion and AS4 submission ourselves.

What really set this project apart was the personal support from Europe IT Consulting. It felt like we had a temporary Regulatory Affairs expert on our team—someone who truly understood the challenges a small company like ours faces. Their responsiveness and ability to think alongside us made all the difference.”

CEO of the MedTech Startup:
“As a small company, we must allocate our resources strategically. The combination of Excel template, data submission service, and personal consulting enabled us to meet all regulatory requirements without launching a complex IT project. The cost savings compared to a full software solution were significant, and the ROI was immediately tangible.

What mattered most to me as CEO: I could trust that our RA Manager was getting excellent support. The close collaboration with Europe IT Consulting gave us the confidence that we wouldn’t make critical mistakes. In regulatory matters, even one error can have major consequences—and that concern was taken off our shoulders by this professional partnership.”

Lessons Learned and Best Practices

Based on this project, we recommend the following practices for similarly positioned companies:

  1. Match the solution to company size: For small product portfolios, an Excel-based solution with professional support can be more cost-effective than complex software systems.
  2. Start with structured data: Using validated templates from the beginning prevents rework and corrections later on.
  3. Engage experts early: Especially for technical aspects like XML formatting and AS4 transmission, specialist input is invaluable.
  4. Prioritize personal support: Having a dedicated advisor who understands your company’s specific challenges is often more impactful than technical features.
  5. Document everything: Ensure all submission steps are fully traceable for future audits and certifications.
  6. Establish sustainable processes: Even with Excel-based solutions, clearly defined responsibilities and update routines are essential.

Outlook

Following successful initial UDI submission, the company plans to continue its collaboration with Europe IT Consulting:

  • Regular product data updates via the Data Submission Service
  • Ongoing regulatory consulting for emerging changes
  • Continued adaptation to new authority requirements
  • Possible expansion to other markets such as the UK and USA

“As we grow, we’ll evaluate whether transitioning to a more comprehensive solution like the Global UDI SAP Add-On makes sense,” the CEO explains. “For now, the Excel template, combined with professional submission service and personal consulting, provides exactly the right level of support with optimal cost efficiency. We appreciate the flexibility of Europe IT Consulting in offering solutions tailored to our size—and treating us with the same care as a large client. It’s reassuring to know we have a partner who can grow with us and support us on every step of our regulatory journey.”