Up-to-dateness of registration information is the responsibility of the medical device operator

All medical device operators subject to the registration obligation must ensure that their registration information is correct and up-to-date either in the EU’s EUDAMED database or in Fimea’s national CERE register. The up-to-dateness of registration information is always the operator’s responsibility.

The obligation applies to all economic operators with the obligation to notify medical devices. These include manufacturers, importers, authorised representatives, system or procedure pack assemblers or steriliser thereof, distributors and sterilisation service providers, self-manufacturers, and manufacturers of custom-made devices.

Registration information must be kept up to date in the register in which the registration has been made and any changes must be notified without delay.

What changes require an update?

Registration information must be updated whenever changes take place in the information notified to the register. For example, these include: 

• change of the company name, business ID, address or contact details
• changes in the operator’s role
• change of contact persons
• termination of operation or the operator no longer works with medical devices.

Other changes related to operation, such as placing new medical devices on the market or changes to already registered devices, also require that the information be updated in the appropriate register.

It is advisable to check registration information regularly

Although changes must be notified without delay when they take place, it is good practice to review the registered data regularly, for example once a year. The annual review of the registered information should be carried out towards the end of the year, as the supervision fee for the following year is determined on the basis of the information submitted to the register by the end of the year.

For example, the following can be included in the annual review:

• going through the registered information
• verifying the registration against the operator’s actual operation
• checking the validity and the sufficient validity period of the user IDs in EUDAMED.

Regular reviews help to identify any update needs in time.

Operators are urged to contact Fimea with a low threshold in unclear situations. Advice on registration matters can be obtained from Fimea’s service mailbox [email protected], which can be contacted in questions related to both EUDAMED and CERE registrations.

Up-to-date information supports supervision and patient safety

Up-to-date register information is an essential part of the supervision and traceability of medical devices and helps to ensure their patient safety. Inadequate or outdated information may complicate regulatory supervision and cause unnecessary costs for operators, for example, in the form of supervision fees.

Further information on the registration obligations and instructions for updating information in EUDAMED and CERE can be found on Fimea’s website.

Device and operator registrations 

Device and operator notifications to EUDAMED 

Device and operator notifications to CERE 

Fimea Regulation 2/2021 (Finlex) (in Finnish and Swedish)