Medical devices illustration

Incident reporting

Incident reporting

Medical device adverse incidents must always be reported to the Finnish Medicines Agency Fimea as soon as possible.

Serious adverse incidents shall be reported within ten (10) days of the user or manufacturer first becoming aware of the incident. The cases of a near incident should be reported within thirty (30) days.

The duty to report applies to manufacturers and professional users of medical devices in Finland. Serious adverse incidents caused by a medical device made by a Finnish manufacturer occurring in another EEA State shall be reported to the authorities of the State where the incident occurred.

Failure to report is a punishable offence.

In urgent cases, reports may be made by telephone to +358 29 522 3341. However, a written report shall also always be filed without delay.

Finnish Medicines Agency Fimea has issued regulations on reporting serious adverse incidents for users and manufacturers (in Finnish). The regulations are in force from 15 September 2010.

Finnish Medicines Agency Fimea notifies manufacturers, users and other relevant parties of steps to be taken in the event of a serious adverse incident.

Notifications are sent to the following address:

by email:
meddev.vigilance@fimea.fi

by mail:
Finnish Medicines Agency Fimea
Medical Devices
Mannerheimintie 166
P.O.Box 55
FI-00034 Helsinki
FINLAND

Notifications can also be sent by fax +358 29 522 3002.

Guidelines on a Medical Devices Vigilance System

GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM MEDDEV 2.12-1 rev 8

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8

Manufacturer Incident Report (pdf-format)

Manufacturer Incident Report (MIR) (pdf-format), Helptext 

Field Safety Corrective Action (FSCA-report)