EUDAMED Actor Registration

Company registrations are submitted in the EUDAMED Actor Registration Module. Once the Actor registration is approved, companies are issued a unique Single Registration Number (SRN).

What is an Actor?

Simply put, an Actor is any organization that is required to register in EUDAMED.

Actors include Supervising Entities (e.g., European Competent Authorities), in addition to Economic Operators.

Per the EU Commission’s document on Actor Roles:

“An actor is a natural or legal person (organisation) with a specific role that has to be registered in EUDAMED.”

Which Economic Operators have to register in EUDAMED?

The following Economic Operators must register in EUDAMED as Actors:

• • Manufacturers (both EU and non-EU)
  • System/procedure pack producers
  • Authorised Representatives
  • Importers

While distributors are also Economic Operators and must meet certain obligations under the MDR/IVDR, they will not register in EUDAMED.

How do I register my company EUDAMED?

The first step is to go to the EUDAMED website: Home Page

This EUDAMED website is not the same as the public access website. This is the one specifically for registration purposes.

Once there, select “Create your EU login account” to get started.

The general information needed for the Actor registration:

• • Company name, address and email address for the general public
  • Select which national Competent Authority should approve your registration request
    • If you are a European company, it is the Competent Authority where you are located; if you are a non-European company, it is the Competent Authority where your Authorized Representative is located
  • Identify your European Authorized Representative (applicable only for non-EU manufacturers)
    • Then, upload the Authorized Representative Mandate Summary Document
  • Upload signed Declaration on Information Security Responsibilities
  • Identify your organization’s Person Responsible for Regulatory Compliance (PRRC)

Once you have entered the above information, submit the request. It will first be reviewed by your Authorized Representative (if applicable) and then finally by the Competent Authority, who will issue your Single Registration Number (SRN).

For more information, please read: What is an SRN?

NOTE: the first person to start the Actor registration, by default, becomes the Local Actor Administrator (LAA) for that account. This is the highest-level access one can have for the EUDAMED account and this role is responsible to grant approvals for other employees to register. That said, once the Actor registration is complete, others can request to register themselves as additional LAAs. Each person will have their own personal log-in.

The EU Commission has published a User Guide and video (no sound).

How long will it take to be issued a Single Registration Number (SRN)?

Timing depends on your Authorized Representative and the Competent Authority. Once you submit the Actor registration, the following steps will occur:

1. 1. If you are a non-EU manufacturer, the request will be routed to your Authorized Representative (AR). The AR will either approve, send it back for corrections, or reject it.
   2. Once the AR approves the registration, it then goes to the national Competent Authority (CA) for final approval. 

The total timeframe, therefore, depends on how long it takes your authorized representative (if applicable) to review your registration application. Then, how long it takes for you to make corrections (if needed). And finally, how long it takes the Competent Authority to approve the Actor registration request. Each Competent Authority has a different target based on its own resources and goals. The Irish Competent Authority, where Casus is located, endeavors to review all Actor requests within two working days. However, some estimate 2-6 weeks to process Actor requests.

Once the Competent Authority approves the registration, they will then issue the Single Registration Number (SRN).

Once the SRN has been issued, manufacturers are able to submit their device registrations in the EUDAMED UDI/Device Registration Module.

For more information, please read: Registering Devices in EUDAMED

Note for System/Procedure Pack Producers (S/PPP)

The Authorized Representative (AR) will not review Actor registration requests for System/Procedure Pack Producers (S/PPP), even if the S/PPP is not based in the EU. Instead, the non-EU S/PPP should identify the most applicable Competent Authority (CA) to review the request.

As general practice, the S/PPP should select the same CA as where their AR is located, even though the AR will not review the S/PPP request. The Irish CA, for example, recommends this and asks that the S/PPP include the AR’s information in the application comments section for faster processing.

Note for Custom-made Device Manufacturers

Manufacturers of custom-made devices are not issued a Single Registration Number. Instead, they are issued an Actor ID.

Custom-made device manufacturers are fully exempt from EUDAMED UDI/Device registration requirements. However, Class III custom-made implantable devices require Notified Body certification, covering the quality management system. And the Notified Body must then register the Certificate in EUDAMED.

Further, all custom-made device manufacturers are required to submit vigilance and post-market surveillance data into EUDAMED, once fully functional. Therefore, they are not exempt from registering as an Actor/Economic Operator, as this step is required in order to submit vigilance.