EU EUDAMED Medical Device & IVD Registration

EUDAMED registration: what is mandatory now?

EUDAMED is the European database supporting the MDR and IVDR. It connects economic-operator, device and certificate information. Registration does not replace CE conformity assessment or turn a database entry into product approval.

The European Commission’s current overview confirms mandatory use of four modules from May 28, 2026. Each module has a different owner and purpose:

Until the remaining modules’ requirements apply, follow the current national/Commission arrangements for vigilance and study reporting. A forecast on a roadmap is not itself a mandatory-use date.

Which devices have a November 2026 deadline?

The Commission’s transition diagram identifies November 28, 2026 for relevant legacy and Regulation devices already placed on the market before mandatory use, where further units continue to be placed. New Regulation devices first placed after May 28, 2026 generally need registration before placement. Apply the specific transition case, including earlier registration triggered by relevant vigilance needs.

Do not give every product a blanket six-month extension. Classify the portfolio by Regulation/legacy status, first-placement history, continuing placement and any incident or safety action. A transition for CE certification is different from a transition for database registration.

Actor registration and the SRN

Create the appropriate EU Login access, identify the actor role and enter consistent legal-entity details. A non-EU manufacturer’s request involves its EU Authorized Representative; the competent authority validates the applicable registration. The Single Registration Number (SRN) identifies the actor and role, not a device authorization.

Check legal names, addresses, mandates, actor links and the PRRC information required for the role. Not every supply-chain business registers as the same actor type: a distributor is not automatically an importer or manufacturer. Assign a primary account owner and a backup, and control who can change records.

Prepare the device data before upload

For a Regulation device, reconcile the Basic UDI-DI, UDI-DI, issuing entity, EMDN code, class, intended purpose, model/catalogue information, responsible actor and certificate links where applicable. Basic UDI-DI groups devices for regulatory purposes; UDI-DI identifies a device/model level. UDI-PI contains production information and is not a requirement to upload each serial number or lot as a separate EUDAMED device record.

Legacy devices use the applicable EUDAMED DI/ID identification scheme, with specific linking rules when transitioning to Regulation devices. Do not impose every MDR/IVDR UDI-labeling obligation on a legacy device solely because database registration is required. Custom-made and other special categories need their own applicability assessment.

A controlled registration and maintenance workflow

1. Inventory the devices and determine the applicable deadline case.
2. Validate actors and representation before device entry.
3. Map controlled technical-documentation fields to the database fields and resolve inconsistent names or identifiers.
4. Review the draft/import results, submit and retain evidence of the final registered records.
5. Connect change control to record updates, new-UDI decisions, certificate changes and actor changes.

Link registration work with MDR or IVDR conformity assessment and the PMS program. Switzerland’s swissdamed is a separate system with Swiss obligations. Pure Global can support data preparation, portfolio triage, actor coordination and ongoing maintenance.