EUDAMED Registration Webinar for MDR & IVDR

Navigating EUDAMED: Streamlined Compliance for EU MDR & IVDR Success

We hosted a webinar on navigating EUDAMED and understanding the practical steps manufacturers must take to ensure compliance. Danielle Slegers, our Director of Regulatory Affairs and PRRC, led the session. 

The discussion explored both the regulatory foundations of EUDAMED and the real-world challenges companies face in preparing for device and actor registrations.

For more information about MedEnvoy’s EUDAMED service, click here.

Here are some of the highlights: 

Why EUDAMED Matters 

Danielle began by putting EUDAMED into context. Introduced under the EU MDR and IVDR, the database was created to address past failures in device traceability and recall management. Its goal: to centralize data, improve transparency, and ensure patients and regulators can quickly access critical device information. 

Key Topics Covered 

1. Understanding UDI and Global Perspectives

• • What a UDI is and how it ensures traceability. 

• • Lessons learned from the U.S. FDA’s early adoption of UDI requirements. 

• • How Europe’s Basic UDI-DI structure differs from other regions. 

• • Upcoming databases in Switzerland (Swissmed) and Australia (TGA). 

2. Actor Registration & SRNs

• • Who must register: manufacturers, authorized representatives, importers, and SPP producers. 

• • What’s required to obtain a Single Registration Number (SRN). 

• • Common pitfalls that cause applications to be rejected (e.g., missing documents, inconsistent dates, mandate issues). 

3. Device Registration & Legacy Devices

• • The 130+ data fields required for EUDAMED submissions. 

• • How Basic UDI-DIs cluster devices by purpose, class, and design. 

• • Special considerations for legacy devices that were marketed under the MDD/IVDD. 

4. Compliance Risks & Market Access

• • Real-world examples where shipments were delayed at customs due to labeling or registration gaps. 

• • Why importers will soon be unable to place non-registered devices on the EU market. 

• • The need for proactive preparation ahead of mandatory deadlines expected in 2026. 

5. Data Management Challenges

• • Many companies still rely on large spreadsheets to manage UDI data. 

• • The biggest hurdles reported by attendees: resource constraints, data consistency, and understanding regulatory requirements. 

• • Why centralizing data and aligning QMS processes is critical for ongoing compliance. 

Key Takeaways 

• Start early: Don’t wait until deadlines are officially published. Registration is complex and time-consuming. 

• Validate your data: Inconsistent or incomplete records are the #1 cause of delays. 

• Plan globally: UDI databases are expanding beyond Europe, so prepare for multi-market requirements. 

• Maintain compliance: Updating EUDAMED is not a one-time task—ongoing lifecycle management is essential. 

How MedEnvoy Can Help 

At MedEnvoy, we provide EUDAMED Registration Services to help manufacturers manage actor and device registrations, maintain compliance, and streamline submissions across multiple markets. If you’d like support in preparing your data or handling registrations, our Regulatory Affairs experts are here to help. 

Watch the Full Webinar 

If you would like to dive deeper into timelines, submission steps, and practical guidance, you can watch the full recording here:

About the Speaker

Daniëlle Sleegers

Director of Regulatory Affairs & PRRC, MedEnvoy Global

Daniëlle has more than 15 years of experience in the medical device industry and has been hands-on in international registrations, post-market surveillance, clinical evaluations, and risk management. With her background in Biopharmaceutical Sciences and experience gained when working for the Medicines Evaluation Board of the Netherlands for 5 years before transferring to the medical device industry, she enjoys working in the medical device field to ensure regulatory compliance while supporting market access.