Applying for a Eudamed SRN registration number
Registration of economic operator in EUDAMED
The new regulations for the market authorisation of medical devices (MDR, EU/745) and in vitro diagnostic medical devices (IVDR, EU/746) imply certain changes. One important change for both market players and the EU member states is the obligation to register information centrally in the European EUDAMED database (MDR, Article 31, IVDR Article 28).
In order to gain access to EUDAMED, manufacturers, importers and authorised representatives must register in the EUDAMED actor registration module in order to obtain a single registration number (SRN). This SRN number allows access to EUDAMED and makes it possible, for example:
• to request a conformity assessment from a notified body;
• to submit the obligatory product information about medical devices or in vitro diagnostic medical devices;
• to submit obligatory reports of incidents or corrective actions involving medical devices or in vitro diagnostic medical devices.
The CIBG is the competent authority for the Netherlands as regards the registration of economic operators in the EUDAMED actor registration module. It assesses all new applications and, if approved, grants access to economic operators. If the details are complete and verified, the registered users will receive an SRN.
How do I apply for an SRN?
1. Create an EU login account
EUDAMED is part of the European Commission. In order to access EUDAMED, you first have to create an EU login account via: Create your EU Login account
2. Register in EUDAMED
If you have an EU login account, you should go to the EUDAMED login page.
3. Decide which kind of request you want to submit.
The start screen of the actor registration module will show you 2 options. One option for registering your organisation in order to obtain an SRN is as an actor (manufacturer, importer, authorised representative or system/procedure pack producer). It is also possible to grant access to additional people within your organisation. In this case your organisation will already have an SRN.
o Actor registration: as yet there is no actor (SRN) number for your organisation.
You want to continue registering your organisation. You have to decide who is going to be your organisation's Local User Administrator (LUA). Your organisation's LUA is authorised to validate the user requests and administer an organisation's user accounts.
o Application for access: your organisation is already registered (already has an SRN) and you also need to access EUDAMED. The LUA within your organisation can grant you access to your own organisation.
4. Number from the national commercial register
At step 1 of the actor registration you should enter your number from the national commercial register. At step 2 you should enter the address details associated with the relevant number from the national commercial register.
Allocating the SRN
After completing the actor registration, the competent authority (CIBG) assesses your application for uniqueness (double applications), completeness and registered address in the Netherlands. In the event of a positive assessment, the SRN will be assigned.
The period required to process an SRN application is 15 days.
NB! Due to significant pressure during the coronavirus crisis, the period required to process applications has increased to 40 days.
For more information on future developments of EUDAMED, registration and the issuing of the SRN, please refer to the following websites.
• EUDAMED user documentation: User Guide for Economic Operators
• All European Commission (technical) information on EUDAMED: EUDAMED page
• More information on the obligations of economic operators in EUDAMED: Ministry of Health, Welfare and Sport (VWS) website
We also kindly request that you keep an eye on the CIBG website for any new developments in the future.