EUDAMED Actor Registration

Understanding Your Role in the EUDAMED System

EUDAMED, designed to provide a comprehensive overview of medical devices' lifecycle in the European Union (EU), requires the identification and connection of key organizations involved in the product's journey. These organizations are referred to as "Actors" within the EUDAMED system.

EUDAMED Actors definition

An EUDAMED Actor can be a natural or legal person (organization) that must register in EUDAMED. Actors are categorized into two groups: Supervising Entities and Economic Operators.

Supervising Entities encompass entities responsible for medical device oversight, including CE Marking certification. This group includes the European Commission, Competent Authorities, Designating Bodies, and Notified Bodies. Notified Body data in EUDAMED is sourced from the NANDO list of designated notified bodies.

In the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR), the term "Economic Operator" is used to identify entities involved in the supply chain. Economic Operators include manufacturers, authorized representatives, importers, distributors, and System/Procedure Pack Producers.

Are all Economic Operators considered EUDAMED Actors?

Not all MDR/IVDR Economic Operators are considered EUDAMED Actors. The following Economic Operators require registration in EUDAMED: manufacturers, authorized representatives, importers, and System/Procedure Pack Producers.

While distributors are considered economic operators, they do not need to register in EUDAMED. However, if a distributor also acts as an EU importer for certain devices, they become an Actor and must register as an importer in EUDAMED, specifically for those particular devices. They would not link themselves to any manufacturers/devices for which they are solely acting as distributors.

Guidance for Economic Operators and EUDAMED Actors

As an Economic Operator fulfilling various roles and also acting as a EUDAMED Actor, it is essential to follow the correct registration process. The following steps outline what you need to do:

1. Register in EUDAMED's Actor Registration Module: Manufacturers, System/Procedure Pack Producers, Authorized Representatives, and Importers should register in this module. Obtaining a Single Registration Number (SRN) is crucial, as it serves as your organization's unique identification code, linking your role and devices. The SRN plays a key role in EUDAMED's traceability functionality.

2. Device Registration for Manufacturers and System/Procedure Pack Producers: After obtaining the SRN, manufacturers and System/Procedure Pack Producers must register their devices in EUDAMED's UDI/Device Registration Module. Importers will then link themselves to the specific devices they import into Europe.

Addressing Multiple Economic Operator Functions as an Actor

It's important to note that a single SRN cannot be used for multiple roles. Each SRN is specific to a particular Economic Operator role. If your organization performs multiple functions, such as being both a manufacturer and a System/Procedure Pack Producer, you must register twice in EUDAMED and obtain two SRNs. Even if the company details and the Person Responsible for Regulatory Compliance are identical, the distinct Economic Operator roles require separate registrations.

Responsibilities as a EUDAMED Actor

Beyond the initial registration and device linking, your ongoing responsibilities as a EUDAMED Actor include:

• Entering clinical investigation and performance study data

• Uploading Summary of Safety and Clinical Performance (if applicable)

• Recording incident reports

• Uploading Field Safety Notices

• Ensuring your registration data remains current and complete

The responsibility for entering this data may vary depending on the Actor (e.g., Competent Authorities, Manufacturers), and certain EUDAMED functions are still under development, such as the Clinical Investigations and Performance Studies, Vigilance and Post-market Surveillance, and Market Surveillance Modules.

Benefits of Early Registration

While EUDAMED compliance is not currently mandatory (with the revised mandatory date set for Q2 2024), there are several reasons to register as an Actor early:

• A significant number of organizations must register, and all SRN registrations need to be reviewed by a European National Competent Authority before issuance.

• If you are a non-EU manufacturer, your Authorized Representative and the Competent Authority must review your SRN registration application, potentially causing delays if left until the deadline.

• Importers need to link to the devices they import, so delays in your EUDAMED registration will also affect their compliance.

• Some Competent Authorities, such as the Spanish Health Authority, already require EUDAMED registration.

We encourage you to explore the EUDAMED platform and familiarize yourself with its capabilities. Once fully functional, the database will be a powerful tool for industry stakeholders. To learn more about updated dates and important information, please refer to our public website and registration website.

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