A Single Registration Number is assigned to all medical device legal Manufacturers, Authorized Representatives, System/Procedure Pack Producers and Importers involved in placing medical devices and IVDs on the European market. It is the primary means of identifying these so-called “Economic Operators” (EO) in the EUDAMED database. Distributors are not assigned an SRN but a larger manufacturer with multiple legal entities placing devices on the European market might have multiple SRNs.
Requests for an SRN are submitted via EUDAMED and then reviewed by a national Competent Authority (Ministry of Health) who then issues the number. This portion of the EUDAMED database is called the “Actor Registration Module.” If a manufacturer is located outside of the European Union, their Authorized Representative will verify the registration request and then pass it along to the Competent Authority for review.
The example below shows a hypothetical SRN for each of the four Economic Operators (EO), also known as Actors. The complete SRN consists of four letters followed by nine numbers. The first two letters are the ISO country code where the Economic Operator is based, followed by an abbreviation for the type of EO. The last nine digits are the unique SRN itself.
MF = Manufacturer
AR = Authorized Representative
PR = System & Procedure Pack Producer
IM = Importer
The example importer SRN above is for MedEnvoy Global BV, based in The Netherlands. You can search for Economic Operators on the EUDAMED database here.
How the EUDAMED SRN is used
Once a Single Registration Number is assigned to a device manufacturer it can be used in many places including:
MDR or IVDR Declaration of Conformity
Certificates issued by your Notified Body
Referenced in your technical documentation
Added to a Certificate of Free Sale
It will also be referenced in your Periodic Safety Update Reports (PSUR), field safety notices/corrective actions, incident reports and clinical reports. Also, going forward any request for conformity assessment by a European Notified Body will require an SRN according to Article 31(3) of the MDR.
Timing of the EUDAMED database
Registration in EUDAMED is optional until May 2024. However, it is now possible to register on a voluntary basis, which means that a company can get a real SRN and may, if desired, start using it on their Declaration of Conformity and certificates. It takes little effort to register now so you are advised to do so. As we get closer to the May 2024 deadline there will be a crush of companies scrambling to register and modify procedures. Keep in mind that full compliance in EUDAMED - including reporting of serious incidents - will be required as of May 2024. Thus, all of your Economic Operators, including your importer, must be registered at that time. Better to start now and get your procedures honed.
If you would like to learn more about how Single Registration Numbers are used and how to get one, the European Commission has published many helpful resources on EUDAMED registration which can be found here.