Are you ready for May 28, 2026? Find out why Medtech companies need to come prepared!
In today’s blog, I want to focus on a critical topic for our customers in the Medical Technology industry: mastering global regulatory compliance. With fast-approaching deadlines and increasing complexity, staying ahead is not just an advantage – it's a necessity.
No time to read? Check out the recording of our related Partner Webcast: Navigating EU UDI Requirements 2026: How MedTech Companies Can Prepare for EUDAMED Readiness.
The European Union's Medical Device Regulation (MDR) sets the standard for the use of medical devices in the EU. Device manufacturers need to make sure that every new and existing medical device is correctly registered to maintain market access. In November 2025, the European Commission formally declared four of the six modules of the European database for Medical Devices (EUDAMED) functional, granting a six-month transition period before the use will be mandatory. This period will end on 28 May 2026: From this date on, device manufacturers operating in the EU market will need to register all new devices in the EUDAMED database. For existing devices, registration will become mandatory on 28. November 2026.
So, how can your company get ready?
We are really happy to bring to you, together with our partner p36, the right solution for this registration: the UDI Platform. Built on the SAP Business Technology Platform (BTP), this solution is designed to help you navigate complex requirements with confidence and efficiency, in the EU and worldwide, integrating seamlessly with the SAP product portfolio.
Why should my company use the UDI Platform?
Imagine reducing the effort for UDI data management from 50 hours down to just 5! With the UDI Platform, this isn't just a possibility; it's a reality. The solution automates the end-to-end process, from data collection and validation to submission to regulatory authorities. By eliminating error-prone manual entry and cumbersome spreadsheets, you can achieve up to 90% time savings.
This automation not only accelerates your compliance timeline but also frees up your teams to focus on innovation rather than administrative burdens.
How can I use the UDI Platform with my existing systems?
The UDI Platform is built on the SAP Business Technology Platform (BTP) and features the familiar, user-friendly SAP Fiori design. It is designed to be the central governance solution for all your UDI-related master data. The platform offers seamless, API-driven integration with your existing SAP systems and other data sources like PIM or RIMS. This means you can protect your “single source of truth,” pulling data like Material, Material Text, and Production Identifiers directly from your SAP system into the platform, ensuring data consistency and integrity.
What about the rest of the world?
DI is not just a European challenge. With regulations already active in the USA, China, Australia, South Korea, Saudi Arabia, and more countries on the way, managing global compliance is an ever-expanding program. The UDI Platform is your time-to-market accelerator. It features a Common Device Data Model that allows you to reuse up to 70% of your UDI data across multiple markets. You enter the data once, and the platform helps you adapt and submit it to various authorities like the FDA, NMPA, and European Commission. This centralized approach reduces redundant effort and ensures you stay compliant today and in the future.
Can I see the Platform?
Sure! The platform provides a comprehensive suite of tools, including:
A central dashboard for an at-a-glance view of tasks and submission status:
Dedicated modules for different regulations (MDR, IVDR, Legacy Devices):
A full audit trail with version history for complete traceability:
Data maintenance and approval:
Reporting capabilities:
With bulk processing capabilities via Excel for managing large product portfolios and easy EUDAMED submission, you can audit your data, leveraging optimized processes and increased automation. Track your current submissions and stay ahead of the curve.
So how do I get started?
The 2026 deadlines are approaching, but you don't have to face them unprepared. This tailormade solution provides the automation, integration, and global reach your business needs to turn a complex regulatory hurdle into a competitive advantage.
To learn more and ensure your organization is ready, I encourage you to take the next step:
* Book Your 30-Minute Expert Session Today
* Download the EUDAMED Readiness Checklist
To find out about the UDI Platform, built on SAP BTP, click here!
If you want to hear more about the UDI Platform from the experts, check out the recording of our related Partner Webcast: Navigating EU UDI Requirements 2026: How MedTech Companies Can Prepare for EUDAMED Readiness.
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