Company registrations are submitted in the EUDAMED Actor Registration Module.
Simply put, Actors are the organizations that are required to register in EUDAMED.
Actors include Supervising Entities (e.g., 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.”
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 will not register in EUDAMED.
The first step is to create a EUDAMED account so you can register your company as an Actor and complete the steps needed to be issued a Single Registration Number (SRN).
To do so, go to this EUDAMED website home page and then select “Create your EU login account”. This EUDAMED website is not the same as the public access website. This is the one specifically for registration purposes.
Note that 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. That said, once the Actor registration is complete, others can register themselves as an additional LAA. Each person will have their own personal log-in.
The general information needed for the Actor registration is:
The 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 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.
Manufacturers of custom-made devices are not issued an SRN. Instead, they are issued an Actor ID.
Custom-made device manufacturers are fully exempt from EUDAMED device UDI 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.
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.
Your Actor Registration results in a Single Registration Number (SRN), this is your company’s unique identification number in Europe.
The SRN is issued to you by the European Competent Authority.
If your organization has multiple roles, then you may have multiple SRNs. For example, if a company acts as a System/Procedure Pack Producer (under Article 12 of the MDD or Article 22 of the MDR) and is a manufacturer, then you will submit two Actor registration requests: one as the manufacturer and one as the System/Procedure Pack Producer. Your company will then be issued two SRNs.
Manufacturers must include the SRN in their Declarations of Conformity, CE Marking Certificates (where applicable), the Summary of Safety and Clinical Performance (where applicable), and in the UDI-DI.
The SRN allows direct traceability back to your organization.
Timing depends on your Authorized Representative and the Competent Authority. Once you submit the Actor registration, the following steps will occur:
The total timeframe will depend 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 Consulting is located, endeavors to review all Actor requests within two working days. However, some estimate 2-6 weeks to process Actor requests.
Once the CA approves the registration, they will then issue the Single Registration Number .