SRN for Medical Devices: The Single Registration Number (SRN Number) identifies every economic operator in and outside of EUDAMED. The Actor registration module enables economic operators to submit, by means of an actor registration request, the information necessary to obtain a single registration number (SRN). The SRN is issued once the relevant competent authority has validated the Actor registration request. All medical device legal manufacturers, authorized representatives, system/procedure pack producers, and importers involved in placing the medical devices and IVDs on the European market are provided a single registration number. It’s the most common way of identifying these “Economic Operators” (EO) in the EUDAMED database.


All economic operators or actors who fall under the regulation 2017/745 (MDR) and/or 2017/746 (IVDR) must register in the EUDAMED Actor Module (module 1) Registration, and as a result SRN is mandatory for the following actor: –

  1. Manufacturer (or legal manufacturer)
  2. Authorized Representative (EC REP)
  3. System and procedure pack producer
  4. Importer


Distributors are not assigned an SRN but a larger manufacturer with multiple legal entities placing devices on the European market might have multiple SRNs.


Procedure to attain SRN 

Requests for an SRN are submitted via EUDAMED and then reviewed by a national Competent Authority 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.

*For EU Economic Operators

  1. Actors are required to register with EUDAMED.
  2. Economic operators based in the EU must choose the Competent Authority in the Member State where they are located.
  3. After verifying the request, the responsible Authority can confirm the registration.
  4. The Actor receives SRN via Email-Id.

*For Non-EU Economic Operator

  1. Actors are required to register with EUDAMED.
  2. Non-EU manufacturers must choose the Competent Authority in the Member State where their Authorized Representative is based.
  3. Manufacturers situated outside the EU must ensure that their Authorized Representatives register with EUDAMED as an Economic Operator, who will be notified of the registration request.
  4. The registration request will be forwarded to the Competent Authority once the Authorized Representative has verified the mandate.
  5. Once the registration request has been validated by the appropriate authorities, the SRN is sent to the actor by email.


How to read the SRN correctly?

The SRN is composed of the following letters followed by nine digits. The first two letters represent the ISO country code where the Economic Operator is based, followed by an acronym denoting the type of EO. The final nine digits represent the unique SRN.

  • MF = Manufacturer
  • AR = Authorized Representative
  • PR = System & Procedure Pack Producer
  • IM = Importer

Here is an example of SRN,       CH-AR-000000001

Where CH denotes the country name, AR denotes the Economic Operator, and the rest nine-digit number is the unique number.


Where is the SRN used?

Once a Single Registration Number is issued to a device manufacturer it can be used in various locations including:

  • MDR or IVDR Declaration of Conformity
  • Certificates issued by your Notified Body
  • Referenced in your technical documentation
  • Added to a Free Sale Certificate


It will also be mentioned in your Periodic Safety Update Reports (PSURs), field safety notices/corrective actions, incident reports, and clinical reports. Furthermore, any request for conformity assessment by a European Notified Body in the future shall require an SRN in accordance with MDR Article 31(3).


Author: Mrs. Shireen Khan

Technical Expert, EUDAMED and EU Regisatrtion for Medical Device, I3CGLOBAL

Date: 2022.05.07