Medical device operator and device registrations

The registration of medical devices shall be carried out in two stages.

1. The operator registers either to the Eudamed register or the CERE register, depending on the operator’s role.

• After registration, the operator is assigned an Actor ID/SRN from Eudamed or a reference number from CERE.

1. The actor registers its medical devices related to its operations in the Eudamed database or in Fimea’s CERE register, depending on its role.

• Note! Importers are to link themselves to the manufacturer whose medical devices they import.

Eudamed or Fimea notification forms shall be used when declaring the information. The forms contain the information that is to be provided in the notifications.

Operators obliged to notify Fimea must keep the submitted information up to date (applies to the Eudamed and CERE register). Fimea must be immediately notified of any changes to the registered information, to the same register that the notification was made.

The submitter shall be:

• authorised to represent the company or trader;
• an authorised representative of the manufacturer; or
• any other party responsible for placing the medical device on the market.