EUDAMED Registration

The Medical Devices and the IVD Medical Devices Regulations 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.

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Economic operators must register in EUDAMED, namely importer, EU & non-EU manufacturers, 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).

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.

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.

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.

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Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

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Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
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