Request access
Free access Generate your EUDAMED XML files free of charge and validate them on your EUDAMED test environment (playground) before any production submission. Terms of use
All guides

Independent resource centre

How do you prepare a device and UDI registration?

The manufacturer prepares the dataset for the device type, including UDI identifiers and required information. Data quality and consistency should be checked before submission.

Independent resource, not affiliated with the European Commission. If in doubt, official documentation and your competent authority prevail.

Let's EUDAMED

Points to check

  1. 01

    Identify the applicable dataset: MDR, IVDR or legacy.

  2. 02

    Check Basic UDI-DI, UDI-DI, EMDN nomenclature and relationships between entities.

  3. 03

    Use the technical documentation and datasets published by the Commission.

  4. 04

    Let's EUDAMED can check the Excel file and generate XML; submission and the final result remain in EUDAMED.

Official sourceCommission européenne — EUDAMED

Let's EUDAMED

What Let's EUDAMED does — and does not do

Let's EUDAMED helps prepare, check and transform data into XML files. Registration, SRN issuance and submission remain within EUDAMED or with the competent authority. EUDAMED credentials must never be shared with us.

Excel → XML

Are your data ready to be structured?

Test the Excel → checks → XML workflow on a defined scope with your regulatory team.

Request beta access →