Page Last Updated: 23 January 2024
A Single Registration Number (SRN) is a unique number assigned to your company by a European Competent Authority. SRNs are only issued to companies (‘Economic Operators’) that require registration in EUDAMED (the European Database on Medical Devices). The SRN is then published on EUDAMED’s public website.
The purpose of the SRN is for better traceability and transparency of Economic Operators and the devices associated with them. It is like how a government agency may issue a tax ID to a company, to more easily track that the company is meeting its legal obligations. The SRN similarly provides a clearer understanding of what medical device companies are on the market, what products they are placing on the market, and if they are following through with the obligations as outlined in the Regulation. If you are familiar with the US market, then the EUDAMED SRN is similar in concept to your FDA Establishment Registration Number.
If your organization is not an Economic Operator that must register in EUDAMED, then you do not need, and cannot get, an SRN. For example, EU Distributors are also Economic Operators according to the MDR/IVDR. However, distributors are not required to register in EUDAMED, and therefore do not receive SRNs.
Further, if your organization performs several roles, then multiple SRNs may be needed. For example, if you are a legal manufacturer and a System/Procedure Pack Producer, then you will have two SRNs.
Note that Economic Operators are referred to as ‘Actors’ in EUDAMED. This is why the SRN registration section of EUDAMED is called the Actors registration module.
Without going into all the nuances: Manufacturer = Economic Operator = EUDAMED Actor.
Even if your organization is associated only with MDD/AIMDD/IVDD ‘legacy’ devices, and not with any MDR/IVDR CE marked devices, you are still required to register in EUDAMED.
However, you will be issued an Actor Identifier (ID), instead of an SRN. The Actor ID and the SRN look the same, and practically speaking, have the same function.
To get an SRN, you must register in the EUDAMED ‘Actors’ registration module.
For the steps on how to complete this application, please read: How to register your company in EUDAMED
EUDAMED was originally scheduled to be fully functional by May 26, 2020. However, it has been postponed. For the most current understanding of EUDAMED’s deadlines, please read: EU Commission Proposes EUDAMED Gradual Rollout
In the meantime, some EUDAMED modules are available for voluntary use, such as the Actor module (discussed above) and the UDI/Device registration module.
Industry is strongly encouraged to begin using the system and not wait until the last minute to enter their data. However, until EUDAMED is mandatory, the registration requirements under the MDD/AIMDD/IVDD continue to apply. Therefore, even if you voluntarily register in EUDAMED, you must still register your devices per the MDD/AIMDD/IVDD requirements as well.
For an overview of which devices currently require registration, and where, please read: EU Medical Device & IVD Registration Requirements