How do you register in EUDAMED?
Start by identifying your organisation's role. Actor registration comes before user access and, depending on the role, device registration.
Independent resource centre
Five concise, sourced references to separate actions completed in the official portal from the data preparation work Let's EUDAMED can simplify.
Independent resource centre
Start by identifying your organisation's role. Actor registration comes before user access and, depending on the role, device registration.
An SRN is obtained through an actor registration request. Following review and approval by the competent national authority, EUDAMED generates the Actor ID or SRN.
The manufacturer prepares the dataset for the device type, including UDI identifiers and required information. Data quality and consistency should be checked before submission.
To request actor registration, a non-EU manufacturer needs an active authorised representative and must provide a mandate summary with the request.
Since 28 May 2026, four modules have been mandatory: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market Surveillance.
Let's EUDAMED
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
Test the Excel → checks → XML workflow on a defined scope with your regulatory team.