What is the Actor Registration Module?
The Actor Registration Module is the entry point for stakeholders in the EUDAMED database. It is mandatory for all actors—manufacturers, importers, and authorized representatives—to register and obtain a Single Registration Number (SRN).
The SRN is crucial as it provides access to other EUDAMED modules, including the UDI/Device Registration Module and the Vigilance Module.
Why is Actor Registration Important?
Actor registration ensures that all stakeholders are accounted for in the regulatory framework. Key benefits include:
- Streamlined Compliance: The SRN standardizes processes for regulatory submissions and device tracking.
- Enhanced Traceability: Ensures that each actor can be linked to the devices they manufacture, import, or represent.
- Transparency: Provides authorities with a clear overview of all entities involved in the medical device lifecycle.
Who Needs to Register?
Actor registration is mandatory for:
- Manufacturers: Both EU-based and non-EU manufacturers are required to register to place devices on the EU market.
- Authorized Representatives: Acting on behalf of non-EU manufacturers to ensure compliance.
- Importers: Responsible for verifying the compliance of imported devices.
Steps to Complete Actor Registration
The process of actor registration involves:
- Creating an Account: Access the EUDAMED database to create a user profile.
- Submitting Information: Provide details about your organization, including legal status and contact information.
- Receiving the SRN: Once validated, you will be assigned a Single Registration Number (SRN).
For detailed guidance, refer to the official MDR and IVDR documentation.
Integration with Other Modules
The Actor Registration Module is interconnected with other EUDAMED components, including:
- UDI/Device Registration Module: Ensures that registered devices can be linked to their respective actors.
- Notified Bodies and Certificates Module: Verifies the certification status of devices.
- Vigilance Module: Links actors to incident reports and corrective actions.
To learn more about these modules, see EUDAMED Modules Overview.