EUDAMED Registration and Compliance

• Actor Registration - allows economic operators to register their information, including importers, manufacturers, and authorized representatives.
• Unique Device Identification (UDI) - keeps data specific to the device. All UDI information must be managed by economic operators, who must thereafter send the information to EUDAMED.
• Certificates - keeps EU certifications up to date for every product category.
• Clinical Investigation - keeps records of the gathering and examination of clinical data.
• Vigilance - keeps track of significant incidents.
• Market Surveillance - keeps track of post-market surveillance data.

(Where Module 4 & 5 are not currently fully functional)

What is EUDAMED?

EUDAMED is a centralized electronic database developed by the European Commission to facilitate the exchange of information among manufacturers, authorized representatives, competent authorities, notified bodies, and other stakeholders involved in the medical device regulatory framework. It serves as a platform for registering economic operators and medical devices while supporting post-market surveillance and vigilance activities.

Manufacturers, Authorized Representatives, and Importers are among the economic operators required by Article 31 of EU MDR and Article 28 of EU IVDR to get a Single Registration Number, or "SRN," through EUDAMED Registration.

Manufacturers are required by Article 29 of EU MDR and Article 26 of EU IVDR to add records to the EUDAMED Database for each device, including its UDI data.

Who Must Register?

EUDAMED has been established to improve transparency, traceability and regulatory oversight of medical devices placed on the European market. For manufacturers located outside the European Union, registration in EUDAMED is an essential regulatory requirement before marketing devices within the EU. Non-EU manufacturers must appoint an EU Authorized Representative (EU-Rep) before initiating the registration process. The Authorized Representative must already be registered in EUDAMED to facilitate the manufacturer's registration.

Importance of the Single Registration Number (SRN)

Upon successful registration, the manufacturer receives a Single Registration Number (SRN), which serves as a unique identifier for the organization. The SRN is used in regulatory submissions, technical documentation, declarations of conformity, and communications with competent authorities. Maintaining an active and valid SRN is essential for continued regulatory compliance.

Procedure

• Create an EU Login Account
• Registration Process for Non-EU Manufacturers

1. 01

   Access EUDAMED

2. 02

   Identify the Authorized Representative

3. 03

   Upload Required Documentation

4. 04

   Submit the Registration Request

5. 05

   Obtain the SRN

• Managing Actor Information
• User Access Management
• Device Registration in EUDAMED

Benefits of EUDAMED Registration

• Demonstrates compliance with EU MDR and IVDR requirements.
• Enhances transparency and traceability of medical devices.
• Facilitates communication with competent authorities.
• Supports market access within the European Union.
• Improves regulatory oversight and post-market monitoring.

Get Expert Support for Your EUDAMED Registration.

We can help you with?

• EUDAMED Actor Registration
• Single Registration Number (SRN) Application
• EUDAMED Registration for Non-EU Manufacturers
• Device Registration and UDI Data Support
• EUDAMED User Access and Actor Information Management
• Regulatory Guidance on EUDAMED Requirements