Finland: _ FIMEA Put-Off Submission of Device Notifications Until Further Notice

Finnish Medicines Agency (Fimea) announced on 2 June 2023, put the submission for device notifications on hold due to the large numbers of medical devices queuing up to be notified. According to the Medical Devices Act (719/2021), Section 4, all medical device distributors who distribute devices to retailers, healthcare, and social welfare facilities were required to submit device notifications to Fimea to report their distribution activities.

However, Fimea has not yet come up with a specific date to resume the submission of device notifications. Fimea launched an electronic submission service for medical devices on 2 May 2023, but the service is not applicable for data submission on distributors’ devices.

The electronic submission service can be used for information submission to the national CERE register and it is applicable for:

• In-house manufacturers of social and healthcare units

• Medical devices manufacturers (individual use only, except Class III implantable devices)

• Distributor prior to notification

It is recommended that all distributors check and update all information via the electronic transaction to the CERE register within 60 days.

Source: Finnish Medicines Agency (FIMEA)