EUDAMED Registration

The Medical Devices and the IVD Medical Devices Regulation introduced the requirement to register medical devices in a European database, EUDAMED. EUDAMED aims to ensure a proper traceability level of the devices within the supply chain.

Who should register?

Economic operators must register in EUDAMED, namely importer, EU & non-EU& manufacturer, system and procedure pack producer and authorised representative. Member States, notified bodies, and sponsors must also enter data into the database. Although EUDAMED registration is still not mandatory, manufacturers are highly encouraged to register as actors and their devices. Indeed, some Competent Authorities are envisaging waving the national notification obligation for devices registered in EUDAMED.

The registration of all devices will become mandatory within 24 months after the Commission publishes a notice that EUDAMED is fully functional (or immediately in case of incidents).

How to register?

EUDAMED has six different modules, of which currently the first three are active:

  1. Actor registration
  2. UDI/Devices registration
  3. Notified Bodies and Certificates
  4. Clinical Investigations and performance studies
  5. Vigilance and post-market surveillance
  6. Market Surveillance

The manufacturer should register first as an actor and then proceed to the device registration. To register, manufacturers need to create an account and accurately fill the required information.

Actor registration

The first registration is the actor registration. Manufacturers will add certain data on their company, such as address, regulatory person information, and company identification details. Afterwards, the Authorised Representative will verify the registration before the Competent Authority’s validation. With this registration, manufacturers will receive the SRN number, required by notified bodies for the conformity assessment procedure.

Alternatively, Obelis can assist the manufacturer in the EUDAMED registration process, leading to fast validation and SRN number issuance.

Device registration

To register the device information in EUDAMED, manufacturers must:

  • Ensure the devices comply with the applicable legislation (MDR/IVDR).
  • In the case of non-EU manufacturers, sign a Mandate with the Authorised Representative.
  • Complete the actor registration.
  • Enter the device information in the Device Module, following the user guide provided by the EU Commission.

After completing the registration, the Authorised Representative must verify the UDI and Device information registration in EUDAMED performed by the non-EU manufacturer.

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