What is a EUDAMED SRN (Single Registration Number)?
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What is a Single Registration Number (SRN)?
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, which is the European Database on Medical Devices. The SRN is then made available 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.
Who Needs an SRN?
- Manufacturers (both non-EU and EU-based manufacturers)
- System & Procedure Pack Producers
- Authorized Representatives
- Importers
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, 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.
Note that Economic Operators are referred to as ‘Actors’ in EUDAMED, which is why the SRN registration section of EUDAMED is called the Actor Registration module.
Without going into the nuance: Manufacturer = Economic Operator = EUDAMED Actor.
What if I Only Have MDD/AIMDD/IVDD Devices?
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.
Current EUDAMED Status
EUDAMED was originally scheduled to be fully functional by May 26, 2020. However, EUDAMED has been postponed multiple times. For more information on the timeline, please read: New Mid-2025 Implementation Date?
In the meantime, EUDAMED modules have been released for use on a voluntary basis, including the Actor registration module discussed above. Industry is strongly encouraged to begin using the system and not wait until the last minute to enter their data.
Until EUDAMED is mandatory, industry should continue to follow the registration requirements under the Directives (MDD, AIMDD, IVDD): European Registration Requirements
