What is the EUDAMED Register?

EUDAMED (European Database on Medical Devices) is a European database for medical devices, designed to improve transparency and regulatory oversight in compliance with MDR (2017/745) and IVDR (2017/746) regulations.

Who Needs to Register in EUDAMED?

Registration in EUDAMED is mandatory for:

• Manufacturers of medical devices (both within and outside the EU).
• Importers and authorized representatives placing medical devices on the EU market.
• Distributors involved in the sale of medical devices within Europe.

Registration Process in EUDAMED

1. Company registration in the Actor Registration module – obtaining an SRN (Single Registration Number).
2. Medical device registration in the UDI/Device Registration module – entering product details and assigning a unique identifier (UDI).
3. Uploading technical documentation and clinical evaluation data in the Clinical Investigation & Performance Studies module.
4. Registering certifications and compliance in the Certificates & Notified Bodies module.
5. Submitting safety and incident reports in the Vigilance & Post-market Surveillance module.
6. Monitoring updates and maintaining data as required.

Registration in EUDAMED – is a crucial step for entering the EU market, ensuring compliance with European safety and quality regulations for medical devices.