Applying for a Eudamed SRN registration number
The new rules governing market authorisation for medical devices (Regulation (EU) 2017/745, MDR) and in vitro diagnostic medical devices (Article 30 of Regulation (EU) 2017/746, IVDR) introduce changes. A key change for both economic operators and EU Member States is the obligation to record information centrally in the European EUDAMED database (Article 31 MDR, Article 28 IVDR).
In order to gain access to EUDAMED, manufactures, importers and authorised representatives must register in the EUDAMED actors module to obtain an SRN, a unique registration number. The SRN grants access to EUDAMED and includes features such as:
• requesting a conformity assessment from a notified body;
• providing mandatory product information regarding medical devices or in vitro diagnostic medical devices (IVD);
• submitting mandatory reports regarding incidents or corrective actions in relation to medical devices or IVD.
In the Netherlands, the CIBG is the competent authority for the registration of economic operators in the EUDAMED actor registration module. It will assess all new applications and grant economic operators access on approval. Registered parties will receive an SRN once their data are complete and have been verified.
How do I apply for an SRN?
NB beide links hieronder bestaan al en wijzigen niet
1. Create an EU login account
EUDAMED is part of the European Commission. In order to gain access to EUDAMED, you will first need to create an EU login account at: Create your EU Login account
2. Logging into EUDAMED
Once you have an EU login account, browse to the EUDAMED login page
3. Select the type of request
On the start screen of the actors module, you will see 2 options. The first is an option to register your organisation as an actor (manufacturer, importer, authorised representative or compiler of systems/procedure packs) in order to obtain an SRN. The second is an option to grant access to additional individuals within your organisation. In this case, your organisation already has an SRN.
o Actor registration: your organisation does not have an actor number (SRN) yet.
You want to proceed to register your organisation. You must appoint an individual to act as the local user administrator (LUA) for your organisation. The LUA for your organisation will be authorised to validate user requests and manage the user accounts of the organisation.
o Access request: your organisation registered previously (already has an SRN), and you now also require access to EUDAMED. The LUA for your organisation can grant you access to your own organisation.
4. Number in the national Commercial Register
In Step 1 of the actor registration, enter your number in the national commercial register. In Step 2, enter the address details linked to the relevant number in the national commercial register.
Assignment of an SRN
After you complete the actor registration, the competent authority (CIBG) will assess whether your application is unique (not a duplicate request) and complete and confirm whether you are based in the Netherlands. If the outcome is positive, you will be assigned an SRN.
Applications for an SRN are processed within 15 days.
Please note: as a result of a high number of requests, the processing time has increased to 8 weeks.
For more information regarding future developments of EUDAMED, registration and the issue of SRNs, please visit the following websites:
• EUDAMED User Documentation: User Guide for Economic Operators
• All technical and other information provided by the European Commission regarding EUDAMED: EUDAMED page
• More information on the obligation of economic operators participating in EUDAMED: Ministry of Health, Welfare and Sport website
Please also monitor the current website with regard to future developments.