Page Last Updated: 23 January 2024
Companies are required to register in EUDAMED (the European medical device database). Find out who has to register and how to do so.
Simply put, an Actor is any organization that is required to register in EUDAMED.
Actors include certain Economic Operators and Supervising Entities (e.g., European Competent Authorities).
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.”
The following Economic Operators must register in EUDAMED as Actors:
While distributors are also Economic Operators and must meet certain obligations under the MDR/IVDR, they are not registered in EUDAMED.
Economic Operators are organizations involved in the supply of medical devices onto the European Market. They are defined in the MDR/IVDR as: Manufacturers, System/Procedure Pack Producers, EU Authorized Representatives, EU Importers, and EU Distributors.
Actors are the organizations required to register in EUDAMED. Without going into all the nuances:
Manufacturer = Economic Operator = EUDAMED Actor
System/Procedure Pack Producer = Economic Operator = EUDAMED Actor
EU Authorized Representative = Economic Operator = EUDAMED Actor
EU Importer = Economic Operator = EUDAMED Actor
EU Distributor = Economic Operator ≠ EUDAMED Actor
EUDAMED is currently voluntary; its mandatory use date has been postponed. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout
Until EUDAMED is mandatory, the registration requirements under the MDD/AIMDD/IVDD continue to apply.
For an overview of which devices currently require registration, and where, please read: EU Medical Device & IVD Registration Requirements
The first step is to go to the EUDAMED registration website: Home Page
Once there, select “Create your EU login account” to get started.
The general information needed for the Actor registration:
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). Some Competent Authorities are stricter than others. For example, some may reject an Actor registration for not entering the company registration number, while others will not. Or, some will reject the registration if the street name is abbreviated, while others will not.
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 for granting approvals so that other employees can register. Once the Actor registration is complete, other employees can request to register themselves as additional LAAs, so that multiple people have full administrative access to the account.
Timing depends on your Authorized Representative and the Competent Authority. Once you submit the Actor registration, the following steps will occur:
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. Some Competent Authorities will review Actor requests within 2-3 working days. However, some estimate 2 or more 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.
After you have completed the Actor registration and obtained your SRN:
For more information on the device registration process, please read: EU Guide: Registering medical devices in EUDAMED
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.
Further, the System/Procedure Pack Producer will be issued an Actor ID, instead of a Single Registration Number. For all practical purposes, the the Actor ID and SRN look the same and serve the same purpose.
Manufacturers of custom-made devices are not issued a Single Registration Number. Instead, they are issued an Actor ID. For all practical purposes, the the Actor ID and SRN look the same and serve the same purpose.
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 EUDAMED is fully functional. Therefore, they are not completely exempt from registering as an Actor/Economic Operator, as this step is required in order to submit vigilance.