EUDAMED Registration – A Comprehensive Guide for Manufacturers
EUDAMED Registration: Your Step-by-Step Guide
Compliance with European regulations is essential for placing medical devices on the market, and registering in the EUDAMED database is a key component of this process. Whether you’re new to EUDAMED or need clarity on specific steps, this guide will walk you through the essentials.
What Is EUDAMED?
EUDAMED (European Database on Medical Devices) is a centralized platform established under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It serves to enhance transparency and coordination across EU member states.
Steps for EUDAMED Registration
1. Actor Registration
Start by creating an EU Login account. Then, submit your actor registration, including company details and information about your Person Responsible for Regulatory Compliance (PRRC). Once submitted, your application will be reviewed, and an SRN (Single Registration Number) will be assigned.
2. Authorized Representative Confirmation
Your Authorized Representative must confirm the actor registration submission and accept their role as your official representative in the EU.
3. Device Registration
Using your SRN, access the UDI/Device registration module. Here, you’ll provide detailed information about your medical devices, ensuring full compliance with MDR/IVDR requirements.
Key Considerations for Manufacturers
Authorized Representative: If you work with multiple Authorized Representatives, clearly identify the primary contact for your registrations.
Deadlines: Staying ahead of registration deadlines is crucial for maintaining market access and compliance.
Why Is EUDAMED Registration Important?
EUDAMED not only ensures compliance but also facilitates better monitoring, traceability, and safety of medical devices in the EU market. Proper registration builds trust with regulators, distributors, and end-users.
Need Help?
Navigating EUDAMED can be complex, but you don’t have to do it alone. Our team of experts is ready to guide you through every step of the process, ensuring accuracy and compliance.
Want to discuss in person? Visit us at Arab Health 2025 in Dubai:
➡️ Hall S3, Booth A51
🗓️ 27–30 January 2025
