EUDAMED Actor Registration Step by Step Guide

EUDAMED Actor Registration Module: Why You Should Care?

EUDAMED Actor Registration Module is the first operational module of EUDAMED. In this module, all the economic operators (companies engaged in manufacturing, importing, or distributing medical devices) need to register themselves before any further action within EUDAMED takes place. After registration, every single economic operator gets his/her Single Registration Number (SRN) , a unique EU wide identification number that will be used in all further regulatory procedures. If you are a manufacturer (especially a non EU one), actor registration is the first step to comply with the regulations.

Important Update: Pursuant to the Regulation (EU) 2024/1860 and the publication of Commission Decision (EU) 2025/2371, the Actor Registration module, along with UDI/Device Registration, Notified Bodies & Certificates, and Market Surveillance, became mandatory as of May 28, 2026. Voluntary registration period finished; all relevant economic operators should get their SRNs in order to place devices on the EU market.

Note: EUDAMED Actor Registration Module is just a part of the whole system, but the crucial one as far as without it you can’t use other functional modules of EUDAMED.

Who Is Considered to Be an "ACTOR"?

All the below economic operators are considered to be actors:

• EU manufacturer

• Non EU manufacturer (also known as “third country”)

• Authorized Representative (AR) (for non EU manufacturers)

• EU Importer

• System or Procedure Pack Producer

All the above mentioned economic operators need to be registered in the Actor Module and be certified by their respective national competent authorities (NCA) before placing any devices on the EU market. As far as custom made devices are concerned, manufacturers of custom made class III implantable devices need to be registered in order to allow their Notified Body to upload the corresponding QMS certificate.

Why EUDAMED Actor Registration Is So Important

It Is Legally Required

Since May 28, 2026, it is strictly illegal to place any medical devices or IVDs on the EU market without actor registration in EUDAMED. You cannot submit device data, certificates, and safety reports without being registered as an actor in EUDAMED first.

It Ensures Smooth Market Access

Regulators, importers, and partners need your SRN. Your SRN should be included into your EU Declaration of Conformity, conformity assessment applications, Periodic Safety Update Reports (PSURs), Field Safety Corrective Actions (FSCAs), and serious incident reports. Without it, you won’t be able to go forward with the product launch or CE marking procedure at all.

It Helps You to Access Other EUDAMED Functional Modules

After registration you'll be able to access the following functional modules:

• UDI/Device (mandatory since May 28, 2026 for new devices; deadline for legacy devices is November 28, 2026)

• Notified Bodies & Certificates (mandatory since May 28, 2026)

• Market Surveillance (mandatory for Competent Authorities since May 28, 2026)

Note: The remaining two modules (Vigilance and Clinical Investigation) are still under development and will become mandatory following the future separate notification.

It Helps to Build Up the Transparent Medical Device Ecosystem

The EU uses your Actor Registration in order to verify your role, identity, and responsibilities.

What You Need to Register in the Actor Module

The following documentation is required:

• Company Information: name, legal entity, address, and role (manufacturer, AR, importer, etc.).

• Authorized Representative Mandate (only for non EU manufacturers): a signed document confirming the legal appointment of your AR.

• Information Security Declaration: signed document, confirming your company's responsibilities concerning information security using the appropriate template.

• Proof of Business Existence: business registration certificate or any other official document.

• EUDAMED User Account: you should have an EU Login account in order to submit your application.

Step By Step: How Actor Registration Works

Timeframe: Generally depends on the response time of the particular National Competent Authority and the accuracy and completeness of the documents you upload.

What Will Follow the Registration?

After your Actor Registration is completed, what comes next is:

• Immediate access to the mandatory EUDAMED modules;

• Begin the registration of your devices in the UDI/Device module (All new devices must be registered right away; Legacy devices which have already been put on the market will need to do that until November 28, 2026).

• Ensure your Notified Body will link your certificates to the basic UDI-DI in your registration.

• Assigning internal users with particular access roles (such as Local Actor Administrator);

In case you are a non EU manufacturer, you will need your Authorised Representative to complete his/her registration and accept the mandate before your account can be fully activated and validated by the NCA.

Tips to Help You With a Successful Registration

• Use the official EUDAMED portal EUDAMED Actor Registration.

• Download updated official document templates (Declaration on Information Security, Mandate summary);

• Double check your company registration details and information about the legal representative to avoid immediate rejection of your application by the NCA;

• Assign one of the internal users to manage your EUDAMED access (Local Actor Administrator);

• Follow the email notifications sent to you by the NCA.

Conclusion

Actor Registration Module is much more than just a procedure to go through. It is an official entry point of your company to the European medical device market under the regulation of European Commission EUDAMED. Without a validated registration and a Single Registration Number (SRN), there is no way to access other important EUDAMED modules such as the Device Registration or Certificate Upload. In this regard, SRN becomes a unique identifier of your company in all EU countries, thus providing uniqueness and transparency.