EUDAMED Registration – A Comprehensive Guide for Manufacturers
What is EUDAMED Registration?
EUDAMED Registration is a crucial step for medical device manufacturers, importers, and Authorized Representatives aiming to comply with European regulations. The European Database on Medical Devices (EUDAMED) is a centralized system designed under the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to enhance transparency, traceability, and coordination across EU member states.
If you are new to EUDAMED Registration or need a clear roadmap for compliance, this step-by-step guide will walk you through the process.
Steps for EUDAMED Registration
1. Actor Registration
- Create an EU Login account – This is required to access the EUDAMED portal.
- Submit your actor registration – Provide company details, regulatory information, and details of your Person Responsible for Regulatory Compliance (PRRC).
- Review and approval – The application is reviewed, and if compliant, you will receive a Single Registration Number (SRN), a unique identifier for your company.
2. Authorized Representative Confirmation
- If you operate outside the EU, you need an Authorized Representative.
- The representative must confirm your registration submission and formally accept their role.
- Multiple representatives? Ensure your primary contact is clearly defined to streamline regulatory interactions.
3. Device Registration
- Once you receive your SRN, you must proceed with UDI/Device registration.
- Enter detailed product information into the UDI/Device registration module.
- Ensure compliance with MDR/IVDR requirements.
- Accurately document device attributes, classification, and intended use.
Key Considerations for Manufacturers
- Stay ahead of deadlines – EUDAMED compliance is mandatory for market access.
- Maintain accurate documentation – Errors in registration may lead to delays or non-compliance risks.
- Regularly update your records – Keep all device and actor data up to date in EUDAMED.
Why Is EUDAMED Registration Important?
EUDAMED Registration is not just a regulatory requirement but a way to enhance product traceability, compliance, and safety in the EU medical device market. Proper registration:
- Ensures regulatory compliance with MDR/IVDR.
- Improves monitoring and transparency.
- Builds trust with regulators, distributors, and end-users.
Need Help with EUDAMED Registration?
Navigating EUDAMED Registration can be complex, but you don’t have to do it alone. Our team of experts is here to ensure a smooth registration process, from actor registration to full compliance.
Meet Us at Arab Health 2025
Want to discuss your EUDAMED Registration process in person? Visit us at Arab Health 2025 in Dubai:
- Hall S3, Booth A51
- 27–30 January 2025 📅
Get Expert Guidance
For tailored support and compliance assistance, contact our team today. We help medical device companies streamline their EUDAMED Registration and maintain EU market access hassle-free.
➡️ Hall S3, Booth A51
🗓️ 27–30 January 2025
