Device registration


There are two registers for registering medical device information: the national CERE register maintained by Fimea and the Eudamed register maintained by the European Commission. The public Eudamed register offers citizens, social and health care units and other operators adequate access to information about medical devices on the EU market.

Before selling medical devices, placing them on the market or making them available on the market, an operator liable to submit a notification must notify Fimea of their operation and the devices. The notification can be made to either the CERE register or the Eudamed register.  

Provisions on the obligation to register are laid down in section 49 of the Medical Devices Act (719/2021) and in Chapter III of Regulations EU/2017/745 and EU/2017/746.

Fimea’s Administrative Regulation 2/2021 specifies in greater detail the information concerning the submission of notifications, the information to be notified, and the procedures related to registration. 

Device registration

Device registration

About medical device registration

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. 
    1. After registration, the operator is assigned an Actor ID/SRN from Eudamed or a reference number from CERE.
  2. The actor registers its medical devices related to its operations in the Eudamed database or in Fimea’s CERE register, depending on its role. 
    1. 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.